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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01976364
Registration number
NCT01976364
Ethics application status
Date submitted
29/10/2013
Date registered
5/11/2013
Date last updated
21/05/2020
Titles & IDs
Public title
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
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Scientific title
A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
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Secondary ID [1]
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2011-002169-39
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Secondary ID [2]
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A3921092
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Universal Trial Number (UTN)
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Trial acronym
OPAL BALANCE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tofacitinib
Treatment: Drugs - Tofacitinib
Treatment: Drugs - Methotrexate
Treatment: Drugs - Placebo Methotrexate
Experimental: Tofacitinib -
Treatment: Drugs: Tofacitinib
Tofacitinib 5 mg tablet twice daily
Treatment: Drugs: Tofacitinib
Tofactinib 10 mg tablet twice daily
Treatment: Drugs: Methotrexate
Methotrexate 7.5-20 mg weekly
Treatment: Drugs: Placebo Methotrexate
Placebo to match active methotrexate orally once a week
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
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Timepoint [1]
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Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
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Primary outcome [2]
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Number of Adverse Events (AEs) by Severity
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Assessment method [2]
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An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function).
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Timepoint [2]
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Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
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Primary outcome [3]
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Number of Participants With Abnormal Clinical Laboratory Values
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Assessment method [3]
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Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin [total, direct, indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria.
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Timepoint [3]
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Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
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Primary outcome [4]
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Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
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Assessment method [4]
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Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin[total,direct,indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria.
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Timepoint [4]
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Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study)
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Primary outcome [5]
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Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
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Assessment method [5]
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HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
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Timepoint [5]
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Sub-study: Baseline (Day 1), Month 6
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Primary outcome [6]
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Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6
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Assessment method [6]
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PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.
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Timepoint [6]
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Sub-study: Baseline (Day 1), Month 6
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Secondary outcome [1]
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Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response
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Assessment method [1]
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Participants with 20% improvement from baseline in tender and swollen joint counts and 20% improvement in at least 3 of the 5 measures: Patient's global assessment of arthritis (PtGA), Physician's global assessment of arthritis (PhyGA), participant's assessment of arthritis pain, HAQ-DI and C-reactive protein (CRP) in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
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Timepoint [1]
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Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [2]
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Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response
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Assessment method [2]
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Participants with 50% improvement from baseline in tender and swollen joint counts and 50% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
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Timepoint [2]
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Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [3]
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Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response
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Assessment method [3]
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Participants with 70% improvement from baseline in tender and swollen joint counts and 70% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
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Timepoint [3]
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Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [4]
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Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Assessment method [4]
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HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
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Timepoint [4]
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Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [5]
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Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
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Assessment method [5]
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PsARC is comprised of 4 clinical improvement criteria: greater than or equal to (>=) 20% improvement in PhyGA (VAS), >=20% improvement in PtGA; and >= 30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.
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Timepoint [5]
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Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [6]
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Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Assessment method [6]
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The PGA-PsO was a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).
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Timepoint [6]
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Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [7]
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Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Assessment method [7]
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PASI: combined assessment of lesion severity and body area affected into single score; range =0 (no disease) -72 (maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0 (0%) - 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1 =slight, 2 =moderate, 3 =marked, 4 =very marked. Final PASI =sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.
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Timepoint [7]
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Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [8]
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Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Assessment method [8]
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PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
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Timepoint [8]
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Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [9]
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Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Assessment method [9]
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PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of clinical sign components for erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) and severity estimated by clinical signs components for erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
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Timepoint [9]
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Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [10]
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Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Assessment method [10]
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Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis severity score for a participant was 0-60. Higher score indicated greater severity.
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Timepoint [10]
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Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [11]
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Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Assessment method [11]
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Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
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Timepoint [11]
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Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [12]
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Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Assessment method [12]
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The SPARCC enthesitis index identifies the presence or absence of tenderness at 16 enthesial sites, including (right and left): medial epicondyle humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle, Achilles tendon insertion into calcaneum and plantar fascia insertion into calcaneum. On examination, tenderness was recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicated a greater number of sites that are affected by enthesitis.
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Timepoint [12]
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Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [13]
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Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Assessment method [13]
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BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 centimeter (cm) with higher score represented more severe ankylosing spondylitis disease activity.
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Timepoint [13]
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Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [14]
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Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Assessment method [14]
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BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 cm with higher score represented more severe ankylosing spondylitis disease activity.
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Timepoint [14]
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Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
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Secondary outcome [15]
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Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36
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Assessment method [15]
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The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains were aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores were used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represented better physical health status.
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Timepoint [15]
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Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
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Secondary outcome [16]
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Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36
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Assessment method [16]
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The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.
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Timepoint [16]
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Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
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Secondary outcome [17]
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Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
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Assessment method [17]
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SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning.
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Timepoint [17]
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Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
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Secondary outcome [18]
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Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
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Assessment method [18]
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SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning.
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Timepoint [18]
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Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
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Secondary outcome [19]
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Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
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Assessment method [19]
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The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain.
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Timepoint [19]
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Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
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Secondary outcome [20]
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Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
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Assessment method [20]
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The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions.
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Timepoint [20]
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Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
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Secondary outcome [21]
0
0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Query!
Assessment method [21]
0
0
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represents better vitality.
Query!
Timepoint [21]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [22]
0
0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Query!
Assessment method [22]
0
0
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning.
Query!
Timepoint [22]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [23]
0
0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Query!
Assessment method [23]
0
0
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning.
Query!
Timepoint [23]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [24]
0
0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Query!
Assessment method [24]
0
0
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning.
Query!
Timepoint [24]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [25]
0
0
Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36
Query!
Assessment method [25]
0
0
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this outcome measure.
Query!
Timepoint [25]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30 and 36
Query!
Secondary outcome [26]
0
0
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36
Query!
Assessment method [26]
0
0
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure.
Query!
Timepoint [26]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [27]
0
0
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36
Query!
Assessment method [27]
0
0
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure.
Query!
Timepoint [27]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [28]
0
0
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36
Query!
Assessment method [28]
0
0
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure.
Query!
Timepoint [28]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [29]
0
0
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36
Query!
Assessment method [29]
0
0
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this outcome measure.
Query!
Timepoint [29]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [30]
0
0
Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36
Query!
Assessment method [30]
0
0
The EQ VAS recorded the participant's self-rated health on a vertical VAS as standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state.
Query!
Timepoint [30]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [31]
0
0
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36
Query!
Assessment method [31]
0
0
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better participant status. All responses were added with equal weight to get total score.
Query!
Timepoint [31]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [32]
0
0
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36
Query!
Assessment method [32]
0
0
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Query!
Timepoint [32]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [33]
0
0
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Query!
Assessment method [33]
0
0
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Query!
Timepoint [33]
0
0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Query!
Secondary outcome [34]
0
0
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12
Query!
Assessment method [34]
0
0
HAQ-DI assessed the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
Query!
Timepoint [34]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
Query!
Secondary outcome [35]
0
0
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12
Query!
Assessment method [35]
0
0
PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in mm, swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), SF-36 physical component summary (norm-based domain score were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and CRP in mg/L. PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.
Query!
Timepoint [35]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
Query!
Secondary outcome [36]
0
0
Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12
Query!
Assessment method [36]
0
0
PsARC was comprised of 4 clinical improvement criteria: >=20% improvement in PhyGA (VAS), >=20% improvement in PtGA; and >= 30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.
Query!
Timepoint [36]
0
0
Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [37]
0
0
Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12
Query!
Assessment method [37]
0
0
The PGA-PsO is a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).
Query!
Timepoint [37]
0
0
Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [38]
0
0
Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12
Query!
Assessment method [38]
0
0
Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage (Head and neck = 10 handprints [1 handprint =10%], upper extremities = 20 handprints [1 handprint =5%], Trunk (including axillae and groin) = 30 handprints [1 handprint =3.33%], lower extremities (including buttocks) = 40 handprints [1 handprint =2.5%]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
Query!
Timepoint [38]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [39]
0
0
Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12
Query!
Assessment method [39]
0
0
Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.
Query!
Timepoint [39]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [40]
0
0
Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12
Query!
Assessment method [40]
0
0
Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.
Query!
Timepoint [40]
0
0
Sub-study: Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [41]
0
0
Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12
Query!
Assessment method [41]
0
0
Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Query!
Timepoint [41]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [42]
0
0
Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12
Query!
Assessment method [42]
0
0
Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Query!
Timepoint [42]
0
0
Sub-study: Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [43]
0
0
Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12
Query!
Assessment method [43]
0
0
Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.
Query!
Timepoint [43]
0
0
Sub-study: Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [44]
0
0
Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12
Query!
Assessment method [44]
0
0
A psoriatic arthritis participant was considered with minimal disease activity if participant had >= 5 of 7 criteria: 1) tender/painful joint count less than or equals to (<=) 1; (2) swollen joint count <=1; (3) BSA <=3%; (4) Patient Assessment of Arthritis Pain (VAS) <=15 mm; (5) PtGA (VAS) <=20 mm; (6) HAQ-DI score <=0.5; (7) tender entheseal points (using LEI) <=1.
Query!
Timepoint [44]
0
0
Sub-study: Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [45]
0
0
Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12
Query!
Assessment method [45]
0
0
68 joints were assessed to determine joints that are considered tender or painful. Response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Done/Not Applicable (to be used for artificial or missing joints). The 68 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Query!
Timepoint [45]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [46]
0
0
Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12
Query!
Assessment method [46]
0
0
Joints were assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Sixty-six (66) joints were assessed for swelling. The 66 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Query!
Timepoint [46]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [47]
0
0
Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12
Query!
Assessment method [47]
0
0
The investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and independent of the PtGA and Patient Assessment of Arthritis Pain. The investigator's response was recorded using a 100 mm VAS where 0 =PSA not active at all and 100 =PSA extremely active. Higher score indicated more PSA.
Query!
Timepoint [47]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [48]
0
0
Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12
Query!
Assessment method [48]
0
0
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participant's response were recorded using a 0 - 100 mm VAS where 0 =not affected at all and 100 =extremely affected. Higher score indicated worse condition due to PSA.
Query!
Timepoint [48]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [49]
0
0
Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12
Query!
Assessment method [49]
0
0
Participants assessed the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. Higher score indicated more severe pain.
Query!
Timepoint [49]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [50]
0
0
Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12
Query!
Assessment method [50]
0
0
The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay.
Query!
Timepoint [50]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [51]
0
0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [51]
0
0
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.
Query!
Timepoint [51]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [52]
0
0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [52]
0
0
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.
Query!
Timepoint [52]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [53]
0
0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [53]
0
0
SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting & carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence & extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning.
Query!
Timepoint [53]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [54]
0
0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Physical Domain Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [54]
0
0
SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning.
Query!
Timepoint [54]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [55]
0
0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [55]
0
0
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain.
Query!
Timepoint [55]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [56]
0
0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [56]
0
0
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions.
Query!
Timepoint [56]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [57]
0
0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [57]
0
0
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represented better vitality.
Query!
Timepoint [57]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [58]
0
0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [58]
0
0
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning.
Query!
Timepoint [58]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [59]
0
0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [59]
0
0
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning.
Query!
Timepoint [59]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [60]
0
0
Sub Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [60]
0
0
The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning.
Query!
Timepoint [60]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [61]
0
0
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [61]
0
0
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better participant status. All responses were added with equal weight to get total score.
Query!
Timepoint [61]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [62]
0
0
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [62]
0
0
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Query!
Timepoint [62]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [63]
0
0
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12
Query!
Assessment method [63]
0
0
FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.
Query!
Timepoint [63]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [64]
0
0
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12
Query!
Assessment method [64]
0
0
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this measure.
Query!
Timepoint [64]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [65]
0
0
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12
Query!
Assessment method [65]
0
0
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure.
Query!
Timepoint [65]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [66]
0
0
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12
Query!
Assessment method [66]
0
0
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure.
Query!
Timepoint [66]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [67]
0
0
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain
Query!
Assessment method [67]
0
0
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure.
Query!
Timepoint [67]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [68]
0
0
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12
Query!
Assessment method [68]
0
0
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this measure.
Query!
Timepoint [68]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Secondary outcome [69]
0
0
Sub Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12
Query!
Assessment method [69]
0
0
The EQ VAS recorded the participant's self-rated health on a vertical VAS as standard verticle 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state.
Query!
Timepoint [69]
0
0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Query!
Eligibility
Key inclusion criteria
- Previous participation in qualifying PsA study involving tofacitinib
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Time from End of Study visit of qualifying study is >3 months.
- Pregnant female, breastfeeding female or female of childbearing potential unwilling or
unable to use highly effective birth control for duration of study and one ovulatory
cycle thereafter.
Sub-study Inclusion Criteria:
- Subjects who have completed at least 24 months of treatment with tofacitinib in the
extension study
- Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)
Sub-study
-Subjects who are receiving methotrexate by a route other than oral
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/02/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
20/05/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
686
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Rheumatology Research Unit - Maroochydore
Query!
Recruitment hospital [3]
0
0
Pacific Private Clinic - Southport
Query!
Recruitment hospital [4]
0
0
Emeritus Research - Camberwell
Query!
Recruitment hospital [5]
0
0
St. Vincent's Hospital (Melbourne) - Fitzroy
Query!
Recruitment hospital [6]
0
0
St. Vincent's Hospital - Fitzroy
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [3]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [4]
0
0
3124 - Camberwell
Query!
Recruitment postcode(s) [5]
0
0
3065 - Fitzroy
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Idaho
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Minnesota
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nebraska
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Hampshire
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Ohio
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Pennsylvania
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
South Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Utah
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Washington
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Brabant Flamand
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Brussels
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Genk
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Gent
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Leuven
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Merksem
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
MG
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
PR
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
RS
Query!
Country [30]
0
0
Bulgaria
Query!
State/province [30]
0
0
Pleven
Query!
Country [31]
0
0
Bulgaria
Query!
State/province [31]
0
0
Plovdiv
Query!
Country [32]
0
0
Bulgaria
Query!
State/province [32]
0
0
Stara Zagora
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Ontario
Query!
Country [34]
0
0
Czechia
Query!
State/province [34]
0
0
Brno
Query!
Country [35]
0
0
Czechia
Query!
State/province [35]
0
0
Ostrava
Query!
Country [36]
0
0
Czechia
Query!
State/province [36]
0
0
Praha 2
Query!
Country [37]
0
0
Czechia
Query!
State/province [37]
0
0
Praha 4
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Uherske Hradiste
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Mecklenburg-vorp
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Berlin
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Frankfurt am Main
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Freiburg
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Homburg
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Koeln
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Olsberg
Query!
Country [46]
0
0
Hungary
Query!
State/province [46]
0
0
Budapest
Query!
Country [47]
0
0
Hungary
Query!
State/province [47]
0
0
Veszprem
Query!
Country [48]
0
0
Mexico
Query!
State/province [48]
0
0
D.F
Query!
Country [49]
0
0
Mexico
Query!
State/province [49]
0
0
Distrito Federal
Query!
Country [50]
0
0
Mexico
Query!
State/province [50]
0
0
Jalisco
Query!
Country [51]
0
0
Mexico
Query!
State/province [51]
0
0
Sinaloa
Query!
Country [52]
0
0
Mexico
Query!
State/province [52]
0
0
Yucatan
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Chihuahua
Query!
Country [54]
0
0
Poland
Query!
State/province [54]
0
0
Mazowieckie
Query!
Country [55]
0
0
Poland
Query!
State/province [55]
0
0
Bialystok
Query!
Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Bydgoszcz
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Elblag
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Grodzisk Mazowiecki
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Lodz
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Lublin
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Nadarzyn
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Poznan
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Torun
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Warszawa
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Wroclaw
Query!
Country [66]
0
0
Russian Federation
Query!
State/province [66]
0
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Republic OF Tatarstan
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Country [67]
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Russian Federation
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State/province [67]
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Moscow
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Country [68]
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Russian Federation
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State/province [68]
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Novosibirsk
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Country [69]
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Russian Federation
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State/province [69]
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Petrozavodsk
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Country [70]
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Russian Federation
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State/province [70]
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Saratov
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Country [71]
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Russian Federation
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State/province [71]
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Tomsk
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Country [72]
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Russian Federation
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State/province [72]
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Yaroslavl
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Country [73]
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Slovakia
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State/province [73]
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Bratislava
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Country [74]
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Slovakia
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State/province [74]
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Martin
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Country [75]
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Slovakia
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State/province [75]
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Rimavska Sobota
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Country [76]
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Spain
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State/province [76]
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A Coruna
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Country [77]
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Spain
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State/province [77]
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Barcelona
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Country [78]
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Spain
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State/province [78]
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Cantabria
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Country [79]
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Spain
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State/province [79]
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Sevilla
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Country [80]
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Spain
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State/province [80]
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Valencia
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Country [81]
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Taiwan
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State/province [81]
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Chia-Yi
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Country [82]
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Taiwan
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State/province [82]
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Kaohsiung City
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Country [83]
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Taiwan
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State/province [83]
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Taichung
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Country [84]
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Taiwan
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State/province [84]
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Taipei
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Country [85]
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United Kingdom
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State/province [85]
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Essex
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Country [86]
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United Kingdom
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State/province [86]
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WEST Midlands
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Country [87]
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United Kingdom
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State/province [87]
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WEST Yorkshire
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Country [88]
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United Kingdom
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State/province [88]
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Wirral
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Country [89]
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United Kingdom
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State/province [89]
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Bath
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Country [90]
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United Kingdom
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State/province [90]
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York
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
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Summary
Brief summary
This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability
and efficacy of tofacitinib in subjects with active PsA who have previously participated in
randomized studies of tofacitinib for this indication.
This study will include a sub-study to evaluate the efficacy, safety and tolerability of
tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to
tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be
available to subjects who have completed at least 24 months of participation in the
open-label extension study and meet eligibility criteria for the sub-study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01976364
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01976364
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