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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/NCT04115748
Registration number
NCT04115748
Ethics application status
Date submitted
2/10/2019
Date registered
4/10/2019
Date last updated
16/05/2022
Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy
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Scientific title
A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy
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Secondary ID [1]
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2019-001996-35
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Secondary ID [2]
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GS-US-431-4566
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Universal Trial Number (UTN)
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Trial acronym
PENGUIN 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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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 - Filgotinib
Treatment: Drugs - Adalimumab
Treatment: Drugs - Placebo to match filgotinib
Treatment: Drugs - Placebo to match adalimumab
Experimental: Filgotinib 200 mg (Main Study) - Participants will receive filgotinib 200 mg + placebo to match (PTM) filgotinib 100 mg + PTM adalimumab injection for up to 16 weeks.
Experimental: Filgotinib 100 mg (Main Study) - Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg + PTM adalimumab for up to 16 weeks.
Active Comparator: Adalimumab (Main Study) - Participants will receive PTM filgotinib 200 mg + PTM filgotinib 100 mg + adalimumab 40 mg injection for up to 16 weeks.
Placebo Comparator: Placebo (Main Study) - Participants will receive PTM filgotinib 200 mg + PTM filgotinib 100 mg + PTM adalimumab injection for up to 16 weeks.
Experimental: Filgotinib 200 mg (Long Term Extension [LTE]) - Participants will receive filgotinib 200 mg + PTM filgotinib 100 mg for up to 34 weeks.
Experimental: Filgotinib 100 mg (LTE) - Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 34 weeks.
Treatment: Drugs: Filgotinib
Tablets administered orally once daily with or without food
Treatment: Drugs: Adalimumab
Injection administered subcutaneously once every 2 weeks
Treatment: Drugs: Placebo to match filgotinib
Tablets administered orally once daily with or without food
Treatment: Drugs: Placebo to match adalimumab
Injection administered subcutaneously once every 2 weeks
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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 Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12
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Assessment method [1]
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ACR20 response is achieved when the participant has: = 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: patient's global assessment of disease activity (PGADA) using a visual analogue scale (VAS) on a scale of 0 (very well) to 100 (very poor); physician's global assessment of disease activity (PHGADA) using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); health assessment questionnaire-disability index (HAQ-DI) inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain), and high-sensitivity C-reactive protein (hsCRP).
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16
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Assessment method [1]
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PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA [using VAS on a scale of 0=very well to 100=very poor]; PhGADA [using VAS on a scale of 0=no disease activity to 100=maximum disease activity];36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status];TJC68;SJC66; leeds enthesitis index(LEI) [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis];Tender dactylitis count (TDC) [with a score range of 0 to 60, higher score indicates higher degree of dactylitis];C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. A negative change from baseline indicates improvement.
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Timepoint [1]
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Baseline, 4, and 16 weeks
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Secondary outcome [2]
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Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16
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Assessment method [2]
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MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: TJC68 =1; SJC66 =1; Psoriatic arthritis disease activity score (PASI) =1 for participants with psoriasis covering BSA <3% [PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)]; patient's global assessment of PsA pain intensity (PGAPI) =15 [using VAS on a scale of 0 (no pain) to 100 (serious pain)]; PGADA =20 [using VAS on a scale of 0 (very well) to 100 (very poor)]; HAQ-DI score =0.5; LEI score =1 for participants with enthesitis at baseline.
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Timepoint [2]
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Weeks 4, 8, 12, and 16
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Secondary outcome [3]
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Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16
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Assessment method [3]
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VLDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the VLDA if the participant fulfills all the seven criteria: TJC68 =1; SJC66 =1; PASI score =1 for participants with psoriasis covering BSA <3% [PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)]; PGAPI =15 [using VAS on a scale of 0 (no pain) to (serious pain)]; PGADA =20 [using VAS on a scale of 0 (very well) to 100 (very poor)]; HAQ-DI score =0.5; LEI score =1 with participants with enthesitis at baseline.
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Timepoint [3]
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Weeks 4, 8, 12, and 16
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Secondary outcome [4]
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Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
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Assessment method [4]
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DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA [using VAS on a scale of 0 (very well) to 100 very poor)]; PGAPI [using a VAS on a scale of 0 (no pain) to 100 (serious pain)] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and >28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. A negative change from baseline indicates improvement.
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Timepoint [4]
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Baseline, 2, 4, 8, 12, and 16 weeks
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Secondary outcome [5]
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Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering = 3% of the Body Surface Area (BSA) at Baseline
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Assessment method [5]
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The PhGAP is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity is assessed by a physician according to the grades of induration, erythema, and scaling on a scale of 0 to 5. The sum of the three grades is used to obtain the total average score. PhGAP is based on the total average score on a scale of 0-5 where, 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, and 5 = severe. A negative change from baseline indicates improvement.
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Timepoint [5]
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Baseline, 2, 4, 8, 12, and 16 weeks
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Secondary outcome [6]
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Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline
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Assessment method [6]
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mNAPSI is used to assess each nail abnormality for each of the participant's nails. Three features or groups of features (pitting, onycholysis together with oil-drop dyschromia, and crumbling) of each fingernail are graded on a scale from 0 (no onycholysis together with oil-drop dyschromia, no pitting, no crumbling) to 3 (>30 onycholysis together with oil-drop dyschromia, >50 pitting, >50% crumbling). Four features (leukonychia, splinter, hemorrhages, hyperkeratosis, and red spots in the lunula) are graded with the score of 1 = present or 0 = absent for each fingernail. Each finger has a score between 0 and 13. The total mNAPSI score is the sum of all abnormalities individual score across all fingers, and the total mNAPSI score ranges from 0 to 130. Lower numbers indicate fewer nail abnormalities. A negative change from baseline indicates improvement.
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Timepoint [6]
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Baseline, 4, 8, 12, and 16 weeks
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Secondary outcome [7]
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Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
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Assessment method [7]
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Enthesitis is assessed using LEI. The enthesitis examination by LEI evaluates the presence or absence of pain by applying local pressure on 6 anatomical sites: medial femoral condyle (left and right), lateral epicondyle (left and right), and the achilles tendon insertion (left and right). Enthesitis at each site is scored as 0 (enthesitis absent) and 1 (enthesitis present). LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. A negative change from baseline indicates improvement.
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Timepoint [7]
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Baseline, 4, 8, 12, and 16 weeks
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Secondary outcome [8]
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Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16
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Assessment method [8]
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The PsAID questionnaire assesses the impact of PsA on people's lives. The PsAID is calculated based on 12 numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10. Total score is calculated as the sum of the individual scores, (some of which were multiplied by a weighting factor) divided by 20 for a total possible score of 0 to 10, where higher score indicates worse impact of disease. A negative change from baseline indicates improvement.
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Timepoint [8]
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Baseline, 4, and 16 weeks
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Secondary outcome [9]
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Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16
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Assessment method [9]
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PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA [using VAS on a scale of 0=very well to 100=very poor]; PhGADA [using VAS on a scale of 0=no disease activity to 100=maximum disease activity]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status]; TJC68; SJC66; leeds enthesitis index(LEI) [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; Tender dactylitis count (TDC) [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. PASDAS LDA is defined as PASDAS = 3.2.
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Timepoint [9]
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Weeks 4, and 16
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Secondary outcome [10]
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Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16
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Assessment method [10]
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PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA [using VAS on a scale of 0=very well to 100=very poor]; PhGADA [using VAS on a scale of 0=no disease activity to 100=maximum disease activity]; 36-item short form survey (SF-36) [a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status];TJC68;SJC66; leeds enthesitis index(LEI) [assessed at 6 sites with a score range of 0 to 6, higher scores indicates higher degree of enthesitis]; Tender dactylitis count (TDC) [with a score range of 0 to 60, higher score indicates higher degree of dactylitis]; C-reactive protein (CRP). Total score is calculated as the sum of the individual scores (each score adjusted by weighting factors). The score of PASDAS ranges from 0 to 10, lower scores indicates better function. PASDAS remission is defined as PASDAS = 1.9.
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Timepoint [10]
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Weeks 4, and 16
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Secondary outcome [11]
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Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16
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Assessment method [11]
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ACR20 response is achieved when the participant has: = 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
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Timepoint [11]
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Weeks 2, 4, 8, 12, and 16
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Secondary outcome [12]
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Percentage of Participants Who Achieved an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16
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Assessment method [12]
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ACR50 response is achieved when the participant has: = 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
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Timepoint [12]
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Weeks 2, 4, 8, 12, and 16
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Secondary outcome [13]
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Percentage of Participants Who Achieved an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16
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Assessment method [13]
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ACR70 response is achieved when the participant has: = 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
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Timepoint [13]
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Weeks 2, 4, 8, 12, and 16
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Secondary outcome [14]
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Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16
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Assessment method [14]
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TJC68 is an assessment of 68 joints. Each joint is evaluated as 'normal', 'tender', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all tender joints. The overall tender joint count ranged from 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline indicates improvement.
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Timepoint [14]
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Baseline, 2, 4, 8, 12, and 16 weeks
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Secondary outcome [15]
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Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
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Assessment method [15]
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SJC66 is an assessment of 66 joints. Each joint was evaluated as 'normal', 'swollen', 'tender and swollen', or 'not able to evaluate'. It is derived as the sum of all swollen joints. The overall swollen joint count ranged from 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline indicates improvement.
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Timepoint [15]
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Baseline, 2, 4, 8, 12, and 16 weeks
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Secondary outcome [16]
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Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
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Assessment method [16]
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PGADA is assessed by the participants using a VAS on a scale of 0 (very well) to 100 (very poor). A negative change from baseline indicates improvement.
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Timepoint [16]
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Baseline, 2, 4, 8, 12, and 16 weeks
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Secondary outcome [17]
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Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
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Assessment method [17]
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PhGADA is assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
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Timepoint [17]
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Baseline, 2, 4, 8, 12, and 16 weeks
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Secondary outcome [18]
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Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16
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Assessment method [18]
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HAQ-DI's pain assessment is done using VAS on a scale of 0 (no pain) to 100 (serious pain). A negative change from baseline indicates improvement.
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Timepoint [18]
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Baseline, 2, 4, 8, 12, and 16 weeks
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Secondary outcome [19]
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Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
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Assessment method [19]
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The hsCRP is the ACR core set measure of acute phase reactant. It was measured at the central laboratory to help assess the effect of filgotinib on the participant's psoriatic arthritis. A negative change from baseline indicates improvement.
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Timepoint [19]
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Baseline, 2, 4, 8, 12, and 16 weeks
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Secondary outcome [20]
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Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
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Assessment method [20]
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The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA [using a VAS on a scale of 0 (very well) to 100 (very poor)] and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
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Timepoint [20]
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Baseline, 2, 4, 8, 12, and 16 weeks
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Secondary outcome [21]
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Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16
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Assessment method [21]
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The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28(CRP) = 3.2.
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Timepoint [21]
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Weeks 2, 4, 8, 12, and 16
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Secondary outcome [22]
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Percentage of Participants Who Achieved DAS28 (CRP) Remission at Weeks 2, 4, 8, 12, and 16
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Assessment method [22]
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The DAS28 (CRP) is a measure of the participant's disease activity calculated using the tender joint count (28 joints), swollen joint count (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) remission is defined as DAS28 (CRP) < 2.6.
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Timepoint [22]
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Weeks 2, 4, 8, 12, and 16
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Secondary outcome [23]
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Time to Achieve DAS28 (CRP) LDA
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Assessment method [23]
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The DAS28 (CRP) is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), PGADA (VAS; 0 = very well to 100 = very poor), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. DAS28 (CRP) LDA is defined as DAS28 (CRP) = 3.2. Time to achieve DAS28 (CRP) LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAS28 (CRP) LDA.
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Timepoint [23]
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Up to 19 weeks
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Secondary outcome [24]
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Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16
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Assessment method [24]
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DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA [using VAS on a scale of 0 (very well) to 100 very poor)]; PGAPI [using a VAS on a scale of 0 (no pain) to 100 (serious pain)] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and >28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. DAPSA LDA is defined as DAPSA = 14.
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Timepoint [24]
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Weeks 2, 4, 8, 12, and 16
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Secondary outcome [25]
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Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16
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Assessment method [25]
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DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA [using VAS on a scale of 0 (very well) to 100 very poor)]; PGAPI [using a VAS on a scale of 0 (no pain) to 100 (serious pain)] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and >28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. DAPSA remission is defined as DAPSA = 4.
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Timepoint [25]
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Weeks 2, 4, 8, 12, and 16
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Secondary outcome [26]
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Time to Achieve DAPSA LDA
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Assessment method [26]
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DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA [using VAS on a scale of 0 (very well) to 100 very poor)]; PGAPI [using a VAS on a scale of 0 (no pain) to 100 (serious pain)] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and >28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. Time to achieve DAPSA LDA is the number of days from the first dose date of study drug administration to the first time when a participant achieves DAPSA LDA. If the DAPSA LDA is not achieved during main study phase, the time to achieve DAPSA LDA will be censored at the last non-missing DAPSA LDA assessment date during main study phase. If the component scores of DAPSA LDA are at different dates for a visit, the latest date will be used for the derivation of time to achieve DAPSA LDA.
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Timepoint [26]
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Up to 19 weeks
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Secondary outcome [27]
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Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16
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Assessment method [27]
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The PsARC response is defined as improvement in at least 2 of the following 4 criteria; = 30% decrease in SJC66, = 30% decrease in TJC68, = 20% decrease in PGADA (VAS; 0 = very well to 100 = very poor), = 20% decrease in PhGADA (VAS; 0 = no disease activity to 100 = maximum disease activity), and with at least one of the 2 joint criteria, with no deterioration in any other criteria.
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Timepoint [27]
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Weeks 2, 4, 8, 12, and 16
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Secondary outcome [28]
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Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering = 3% of the BSA at Baseline
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Assessment method [28]
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PASI is assessed in participants with psoriasis covering = 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, where 0 = none, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A higher score indicates more severe disease. A negative change from baseline indicates improvement.
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Timepoint [28]
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Baseline, 4, 8, 12, and 16 weeks
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Secondary outcome [29]
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Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering = 3% of the BSA at Baseline
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Assessment method [29]
0
0
PASI is assessed in participants with psoriasis covering = 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI50, the improvement threshold from baseline in PASI score is 50%. A higher score indicates more severe disease.
Query!
Timepoint [29]
0
0
Weeks 4, 8, 12, and 16
Query!
Secondary outcome [30]
0
0
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering = 3% of the BSA at Baseline
Query!
Assessment method [30]
0
0
PASI is assessed in participants with psoriasis covering = 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI75, the improvement threshold from baseline in PASI score is 75%. A higher score indicates more severe disease.
Query!
Timepoint [30]
0
0
Weeks 4, 8, 12, and 16
Query!
Secondary outcome [31]
0
0
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering = 3% of the BSA at Baseline
Query!
Assessment method [31]
0
0
PASI is assessed in participants with psoriasis covering = 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI90, the improvement threshold from baseline in PASI score is 90%. A higher score indicates more severe disease.
Query!
Timepoint [31]
0
0
Weeks 4, 8, 12, and 16
Query!
Secondary outcome [32]
0
0
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering = 3% of the BSA at Baseline
Query!
Assessment method [32]
0
0
PASI is assessed in participants with psoriasis covering = 3% of the BSA at Baseline. PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head and neck, trunk, upper limbs, and lower limbs. Each of these areas are assessed separately for the percentage of the area involved and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement). The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). For PASI100, the improvement threshold from baseline in PASI score is 100%. A higher score indicates more severe disease.
Query!
Timepoint [32]
0
0
Weeks 4, 8, 12, and 16
Query!
Secondary outcome [33]
0
0
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Query!
Assessment method [33]
0
0
The enthesitis examination is based on the 16 anatomical sites: the medial epicondyle (left and right), the lateral epicondyle (left and right), the supraspinatus insertion (left and right), the bilateral greater trochanter (left and right), the quadriceps tendon insertion into superior border of patella (left and right), the patellar ligament insertion into inferior pole of patella or tibial tuberosity (left and right), the achilles tendon insertion (left and right), and the plantar fascia insertion (left and right). Enthesitis at each site is scored as either 0 (enthesitis absent) and 1 (enthesitis present). SPARCC enthesitis index has an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. A negative change from baseline indicates improvement.
Query!
Timepoint [33]
0
0
Baseline, 4, 8, 12, and 16 weeks
Query!
Secondary outcome [34]
0
0
Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Query!
Assessment method [34]
0
0
LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with an at least 10% difference in the ratio of circumference of the affected digit to the contralateral digit (digit on opposite hand or foot), or if contralateral digit is also affected, values from a standard reference table. Total score= {{[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1}x 100} x Tenderness score. Tenderness score (0 = no tenderness, and 1 = tender). The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index. Lower Leeds Dactylitis Index score represent better outcome. A negative change from baseline indicates improvement.
Query!
Timepoint [34]
0
0
Baseline, 4, 8, 12, and 16 weeks
Query!
Secondary outcome [35]
0
0
Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Query!
Assessment method [35]
0
0
Tender score (0 = no tenderness, 1 = tender, 2 = tender and wince, 3 = tender and withdraw) is collected for Dactylitis Assessments on the Dactylitis Score Sheet that is used for calculation of LDI total score. Tender dactylitis count (TDC) equals the number of tender fingers and toes (tendor score >0). For participants with dactylitis status absent for all the fingers and toes, the TDC is set as 0. The total score range of TDC is from 0 to 60, higher scores indicate greater presence of dactylitis. A negative change from baseline indicates improvement.
Query!
Timepoint [35]
0
0
Baseline, 4, 8, 12, and 16 weeks
Query!
Secondary outcome [36]
0
0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
Query!
Assessment method [36]
0
0
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. A negative change from baseline indicates improvement (less disability).
Query!
Timepoint [36]
0
0
Baseline, 2, 4, 8, 12, and 16 weeks
Query!
Secondary outcome [37]
0
0
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16
Query!
Assessment method [37]
0
0
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Higher scores indicate less fatigue. Positive change in value indicates improvement (no or less severity of fatigue).
Query!
Timepoint [37]
0
0
Baseline, 4, and 16 weeks
Query!
Secondary outcome [38]
0
0
Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16
Query!
Assessment method [38]
0
0
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicated improvement (better health status).
Query!
Timepoint [38]
0
0
Baseline, 4, and 16 weeks
Query!
Secondary outcome [39]
0
0
Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16
Query!
Assessment method [39]
0
0
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. A positive change from baseline indicates improvement (better health status).
Query!
Timepoint [39]
0
0
Baseline, 4, and 16 weeks
Query!
Eligibility
Key inclusion criteria
Key
- Meet Classification Criteria for Psoriatic Arthritis (CASPAR) and have a history
consistent with psoriatic arthritis (PsA) = 6 months at Screening
- Have active PsA defined as = 3 swollen joints (from a 66 swollen joint count [SJC])
and = 3 tender joints (from a 68 tender joint count [TJC]) at Screening and Day 1;
these may or may not be the same joints at Screening and Day 1
- Must have a documented history or active signs of at least one of the following at
Screening:
- Plaque psoriasis
- Nail changes attributed to psoriasis
- Have had inadequate response or intolerance to =1 conventional synthetic
disease-modifying anti-rheumatic drug (csDMARD), apremilast and / or NSAID,
administered over the course of = 12 weeks for the treatment of PsA, as per local
guidelines / standard of care
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Prior PsA or psoriasis treatment with a biologic DMARD
- Prior exposure to a janus kinase (JAK) inhibitor > 2 doses
- Any active / recent infection
- Any chronic and / or uncontrolled medical condition that would put the individual at
increased risk during study participation or circumstances which may make an
individual unlikely or unable to complete or comply with study procedures and
requirements, per investigator judgement
- Any moderately to severely active musculoskeletal or skin disorder other than PsA or
plaque psoriasis that would interfere with assessment of study parameters, as per
judgement of investigator
NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there
is documentation of change in diagnosis to PsA or additional diagnosis of PsA
- Any history of an inflammatory arthropathy with onset before age 16 years old
- Active autoimmune disease that would interfere with assessment of study parameters or
increase risk to the individual by participating in the study (e.g. uveitis,
inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse
myelitis), per judgement of investigator
- Pregnancy or nursing females
- Active drug or alcohol abuse, as per judgement of investigator
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/12/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
11/05/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
67
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Genesis Research Services - Broadmeadow
Query!
Recruitment hospital [2]
0
0
Rheumatology Research Unit - Maroochydore
Query!
Recruitment hospital [3]
0
0
Emeritus Research - Camberwell
Query!
Recruitment postcode(s) [1]
0
0
2292 - Broadmeadow
Query!
Recruitment postcode(s) [2]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [3]
0
0
3124 - Camberwell
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Maryland
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Minnesota
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Missouri
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Nebraska
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Jersey
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Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
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Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
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Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
South Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
West Virginia
Query!
Country [16]
0
0
Bulgaria
Query!
State/province [16]
0
0
Plovdiv
Query!
Country [17]
0
0
Bulgaria
Query!
State/province [17]
0
0
Sofia
Query!
Country [18]
0
0
Bulgaria
Query!
State/province [18]
0
0
Stara Zagora
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Quebec
Query!
Country [20]
0
0
Czechia
Query!
State/province [20]
0
0
Ostrava
Query!
Country [21]
0
0
Hungary
Query!
State/province [21]
0
0
Budapest
Query!
Country [22]
0
0
Hungary
Query!
State/province [22]
0
0
Gyula
Query!
Country [23]
0
0
Japan
Query!
State/province [23]
0
0
Kawachinagano
Query!
Country [24]
0
0
Japan
Query!
State/province [24]
0
0
Nagoya-City
Query!
Country [25]
0
0
Japan
Query!
State/province [25]
0
0
Nagoya
Query!
Country [26]
0
0
Japan
Query!
State/province [26]
0
0
Tokyo
Query!
Country [27]
0
0
Korea, Republic of
Query!
State/province [27]
0
0
Seongnam
Query!
Country [28]
0
0
Korea, Republic of
Query!
State/province [28]
0
0
Seoul
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Country [29]
0
0
New Zealand
Query!
State/province [29]
0
0
WKO
Query!
Country [30]
0
0
New Zealand
Query!
State/province [30]
0
0
Auckland
Query!
Country [31]
0
0
New Zealand
Query!
State/province [31]
0
0
Newtown
Query!
Country [32]
0
0
New Zealand
Query!
State/province [32]
0
0
Timaru
Query!
Country [33]
0
0
Poland
Query!
State/province [33]
0
0
Bialystok, Podlaskie
Query!
Country [34]
0
0
Poland
Query!
State/province [34]
0
0
Bydgoszcz
Query!
Country [35]
0
0
Poland
Query!
State/province [35]
0
0
Dabrówka
Query!
Country [36]
0
0
Poland
Query!
State/province [36]
0
0
Gdynia
Query!
Country [37]
0
0
Poland
Query!
State/province [37]
0
0
Krakow
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Nadarzyn
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Olsztyn
Query!
Country [40]
0
0
Poland
Query!
State/province [40]
0
0
Warsaw
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Warszawa, Mazowieckie
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Warszawa
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Wroclaw
Query!
Country [44]
0
0
Russian Federation
Query!
State/province [44]
0
0
Moskva
Query!
Country [45]
0
0
Russian Federation
Query!
State/province [45]
0
0
Vladimir
Query!
Country [46]
0
0
Russian Federation
Query!
State/province [46]
0
0
Yaroslavl
Query!
Country [47]
0
0
Spain
Query!
State/province [47]
0
0
Madrid
Query!
Country [48]
0
0
Spain
Query!
State/province [48]
0
0
Sabadell
Query!
Country [49]
0
0
Spain
Query!
State/province [49]
0
0
Santander
Query!
Country [50]
0
0
Spain
Query!
State/province [50]
0
0
Sevilla
Query!
Country [51]
0
0
Taiwan
Query!
State/province [51]
0
0
Dailin Township
Query!
Country [52]
0
0
Taiwan
Query!
State/province [52]
0
0
Kaohsiung
Query!
Country [53]
0
0
Taiwan
Query!
State/province [53]
0
0
Keelung
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Country [54]
0
0
Taiwan
Query!
State/province [54]
0
0
New Taipei City
Query!
Country [55]
0
0
Taiwan
Query!
State/province [55]
0
0
Tainan
Query!
Country [56]
0
0
Taiwan
Query!
State/province [56]
0
0
Taipei
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Gilead Sciences
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Galapagos NV
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of this study is to evaluate the effect of filgotinib compared to
placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response
in participants with active psoriatic arthritis who are naive to biologic disease-modifying
anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the
Long Term Extension (LTE).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04115748
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gilead Study Director
Query!
Address
0
0
Gilead Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04115748
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