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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/NCT01470612
Registration number
NCT01470612
Ethics application status
Date submitted
21/10/2011
Date registered
11/11/2011
Date last updated
17/09/2021
Titles & IDs
Public title
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
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Scientific title
A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
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Secondary ID [1]
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2011-004581-14
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Secondary ID [2]
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A3921139
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Universal Trial Number (UTN)
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Trial acronym
OCTAVE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Experimental: CP-690,550 5 mg BID - 5 mg BID
Experimental: CP-690,550 10 mg BID - 10 mg BID
Treatment: Drugs: CP-690,550
5 mg tablets, BID, for at least 12 months
Treatment: Drugs: CP-690,550
10 mg tablets, BID, for at least 12 months
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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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Number of Participants With Treatment Emergent Adverse Events (TEAEs) 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 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.
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Timepoint [1]
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Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
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Primary outcome [2]
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Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs)
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Assessment method [2]
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Serious infections were treated infections that required parenteral antimicrobial therapy or hospitalization for treatment or; met other criteria that required the infection to be classified as a serious adverse event (SAE). 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 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state.
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Timepoint [2]
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Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
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Primary outcome [3]
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Number of Participants With Laboratory Test Abnormalities
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Assessment method [3]
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Laboratory abnormalities: Hemoglobin, hematocrit, RBC: <0.8* LLN; reticulocytes (absolute [Abs], %): <0.5* LLN, >1.5* ULN; MCV, MCH: <0.9* LLN, >1.1* ULN; platelets:<0.5* LLN, >1.75* ULN; WBC:<0.6* LLN,>1.5* ULN; lymphocytes (Abs, %), total neutrophils (Abs,%):<0.8* LLN, >1.2* ULN; Basophils (Abs,%),eosinophils(Abs, %),monocytes(Abs, %):>1.2* ULN; total bilirubin,direct bilirubin,indirect bilirubin:>1.5* ULN; AST,ALT,gamma GT, LDH,ALP: >3.0* ULN; total protein,albumin: <0.8* LLN,>1.2* ULN: BUN,creatinine: >1.3* ULN;uric acid:>1.2* ULN; cholesterol,triglycerides: >1.3* ULN; cholesterol (HDL: <0.8* LLN; LDL: >1.2* ULN); sodium: <0.95* LLN, >1.05* ULN; potassium, chloride, calcium, bicarbonate: <0.9* LLN, >1.1* ULN; glucose: <0.6* LLN; creatine kinase >2.0* ULN; urine specific gravity: <1.003; urine pH: <4.5; urine (glucose,protein,blood,nitrite,leukocyte,esterase): >=1; Urine (RBC,WBC): >=20; urine epithelial cells:>=6; urine (casts,granular casts,hyaline casts): >1; urine bacteria:>20.
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Timepoint [3]
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Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
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Primary outcome [4]
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Number of Participants With Vital Sign Abnormalities
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Assessment method [4]
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Vital sign abnormalities included greater than or equal to (>=) 30 millimeter of mercury [mmHg] increase in systolic blood pressure (BP), >=30 mmHg decrease in systolic BP, Systolic BP (less than [<] 90 mmHg), >=20 mmHg increase in diastolic BP, >=20 mmHg decrease in diastolic BP, diastolic BP (<50 mmHg), pulse rate (<40 beats per minute [BPM]), pulse rate (greater than [>] 120 BPM).
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Timepoint [4]
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Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
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Primary outcome [5]
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Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline
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Assessment method [5]
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Physical examinations included weight, general appearance, head, ears, eyes, nose, mouth, throat, thyroid, skin (presence of rash), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), perianal, musculoskeletal, extremities, neurologic (mental status, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Clinically significant changes were judged by the investigator.
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Timepoint [5]
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Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
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Primary outcome [6]
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Number of Participants With Electrocardiogram (ECG) Abnormalities
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Assessment method [6]
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ECG abnormalities criteria: maximum PR interval (>=300 millisecond); maximum QRS complex (>=200 millisecond); and maximum QT interval (>=500 millisecond).
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Timepoint [6]
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Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
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Primary outcome [7]
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Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events
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Assessment method [7]
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Incidence rates for adjudicated cardiovascular (major adverse cardiovascular event [MACE]), malignancy (non-melanoma skin cancer [NMSC], malignancies excluding NMSC, opportunistic infections (OIs) (both herpes zoster and non herpes zoster OIs) and thromboembolic (venous thromboembolism) safety events were analyzed. This outcome measure was measured in participants with events per 100 participants-years (pt with events/100 pts-yrs).
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Timepoint [7]
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Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
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Secondary outcome [1]
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Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases
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Assessment method [1]
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Remission in participants was defined as a total Mayo score of less than or equals to (<=) 2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
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Timepoint [1]
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Months 2, 12, 24 and 36
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Secondary outcome [2]
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Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
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Assessment method [2]
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Remission in participants was defined as a total Mayo score of <=2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
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Timepoint [2]
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Months 2, 12, 24 and 36
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Secondary outcome [3]
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Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases
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Assessment method [3]
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Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
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Timepoint [3]
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Months 2, 12, 24 and 36
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Secondary outcome [4]
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Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
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Assessment method [4]
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Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
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Timepoint [4]
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Months 2, 12, 24 and 36
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Secondary outcome [5]
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Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases
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Assessment method [5]
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PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.
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Timepoint [5]
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Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
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Secondary outcome [6]
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Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
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Assessment method [6]
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PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total PMS score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.
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Timepoint [6]
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Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
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Secondary outcome [7]
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Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases
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Assessment method [7]
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Mucosal healing in participants was defined as Mayo endoscopic sub score of 0 or 1. The Mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicated higher disease severity.
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Timepoint [7]
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Months 2, 12, 24 and 36
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Secondary outcome [8]
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Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
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Assessment method [8]
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Mucosal healing in participants was defined as mayo endoscopic sub score of 0 or 1. The mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicating higher disease severity.
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Timepoint [8]
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Months 2, 12, 24 and 36
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Secondary outcome [9]
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Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
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Assessment method [9]
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IBDQ was a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease-specific quality of life in participants with inflammatory bowel disease (IBD), including ulcerative colitis consisted of 32 items scored from 1 (worst response) to 7 (best response). For each domain, higher score indicates better quality of life (QOL). Total IBDQ score was the sum of each item score, and ranged from 32 to 224 with a higher score indicated better QOL.
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Timepoint [9]
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Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84
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Eligibility
Key inclusion criteria
- Subjects who completed induction studies A3921094 or A3921095 and were classified as
not meeting clinical response criteria; OR
- Subjects who completed maintenance study A3921096 or who discontinued treatment early
in Study A3921096 due to treatment failure.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease.
- Subjects who have had surgery for ulcerative colitis or in the opinion of the
investigator, are likely to require surgery for ulcerative colitis during the study
period.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/08/2020
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Sample size
Target
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Accrual to date
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Final
944
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Concord Repatriation General Hospital - Concord
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Nepean Hospital - Kingswood
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Liverpool Hospital eastern Campus - Liverpool
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Recruitment hospital [6]
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Eastern Health, Box Hill Hospital - Box Hill
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Recruitment hospital [7]
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Gastroenterology and Hepatology Unit - Clayton
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2050 - Camperdown
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2139 - Concord
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2747 - Kingswood
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2170 - Liverpool
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Recruitment postcode(s) [6]
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3128 - Box Hill
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Recruitment postcode(s) [7]
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3168 - Clayton
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Recruitment outside Australia
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United States of America
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Alabama
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Austria
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Innsbruck
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St. Veit an der Glan
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Hradec Kralove
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Praha 7
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Clichy
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Paris
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Pessac
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Toulouse Cedex 9
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Germany
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Schlewig Holstein
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Germany
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Berlin
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Halle
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Germany
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State/province [58]
0
0
Hannover
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Lüneburg
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Minden
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Munich
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Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Ulm
Query!
Country [63]
0
0
Hungary
Query!
State/province [63]
0
0
Bekescsaba
Query!
Country [64]
0
0
Hungary
Query!
State/province [64]
0
0
Budapest
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Country [65]
0
0
Hungary
Query!
State/province [65]
0
0
Debrecen
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Country [66]
0
0
Hungary
Query!
State/province [66]
0
0
Gyula
Query!
Country [67]
0
0
Hungary
Query!
State/province [67]
0
0
Miskolc
Query!
Country [68]
0
0
Hungary
Query!
State/province [68]
0
0
Mosonmagyarovar
Query!
Country [69]
0
0
Hungary
Query!
State/province [69]
0
0
Pecs
Query!
Country [70]
0
0
Hungary
Query!
State/province [70]
0
0
Szeged
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Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Vac
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Country [72]
0
0
Israel
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State/province [72]
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0
Haifa
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Country [73]
0
0
Israel
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State/province [73]
0
0
Holon
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Country [74]
0
0
Israel
Query!
State/province [74]
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0
Petah Tikva
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Country [75]
0
0
Italy
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State/province [75]
0
0
Milano
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Country [76]
0
0
Italy
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State/province [76]
0
0
PA
Query!
Country [77]
0
0
Italy
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State/province [77]
0
0
Catanzaro
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Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Aichi
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Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Aomori
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Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Chiba
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Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Fukuoka
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Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Hokkaido
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Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Ibaraki
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Kagoshima
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Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Kochi
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Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Miyagi
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Osaka
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Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Shiga
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Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Tokyo
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Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Hiroshima
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Country [91]
0
0
Japan
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State/province [91]
0
0
Hyogo
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Country [92]
0
0
Korea, Republic of
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State/province [92]
0
0
Gyeonggi-do
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Country [93]
0
0
Korea, Republic of
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State/province [93]
0
0
Incheon
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Country [94]
0
0
Korea, Republic of
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State/province [94]
0
0
Seoul
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Country [95]
0
0
Latvia
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State/province [95]
0
0
Riga
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Country [96]
0
0
Netherlands
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State/province [96]
0
0
Amsterdam
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Country [97]
0
0
Netherlands
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State/province [97]
0
0
Groningen
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Country [98]
0
0
Netherlands
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State/province [98]
0
0
Leiden
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Country [99]
0
0
New Zealand
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State/province [99]
0
0
BAY OF Plenty
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Country [100]
0
0
New Zealand
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State/province [100]
0
0
Canterbury
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Country [101]
0
0
New Zealand
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State/province [101]
0
0
Auckland
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Country [102]
0
0
New Zealand
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State/province [102]
0
0
Dunedin
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Country [103]
0
0
New Zealand
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State/province [103]
0
0
Hamilton
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Country [104]
0
0
New Zealand
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State/province [104]
0
0
Wellington
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Country [105]
0
0
Poland
Query!
State/province [105]
0
0
Iodzkie
Query!
Country [106]
0
0
Poland
Query!
State/province [106]
0
0
Kujawsko-pomorskie
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Country [107]
0
0
Poland
Query!
State/province [107]
0
0
Mazowieckie
Query!
Country [108]
0
0
Poland
Query!
State/province [108]
0
0
Podlaskie
Query!
Country [109]
0
0
Poland
Query!
State/province [109]
0
0
Slaskie
Query!
Country [110]
0
0
Poland
Query!
State/province [110]
0
0
Krakow
Query!
Country [111]
0
0
Poland
Query!
State/province [111]
0
0
Lodz
Query!
Country [112]
0
0
Poland
Query!
State/province [112]
0
0
Sopot
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Country [113]
0
0
Poland
Query!
State/province [113]
0
0
Warszawa
Query!
Country [114]
0
0
Poland
Query!
State/province [114]
0
0
Wroclaw
Query!
Country [115]
0
0
Romania
Query!
State/province [115]
0
0
Timis
Query!
Country [116]
0
0
Romania
Query!
State/province [116]
0
0
Bucuresti
Query!
Country [117]
0
0
Russian Federation
Query!
State/province [117]
0
0
Moscow
Query!
Country [118]
0
0
Russian Federation
Query!
State/province [118]
0
0
Nizhniy Novgorod
Query!
Country [119]
0
0
Russian Federation
Query!
State/province [119]
0
0
Novosibirsk
Query!
Country [120]
0
0
Russian Federation
Query!
State/province [120]
0
0
Samara
Query!
Country [121]
0
0
Russian Federation
Query!
State/province [121]
0
0
Yaroslavl
Query!
Country [122]
0
0
Serbia
Query!
State/province [122]
0
0
Central Serbia
Query!
Country [123]
0
0
Serbia
Query!
State/province [123]
0
0
Belgrade
Query!
Country [124]
0
0
Serbia
Query!
State/province [124]
0
0
Kragujevac
Query!
Country [125]
0
0
Serbia
Query!
State/province [125]
0
0
Novi Sad
Query!
Country [126]
0
0
Serbia
Query!
State/province [126]
0
0
Zrenjanin
Query!
Country [127]
0
0
Slovakia
Query!
State/province [127]
0
0
Bratislava
Query!
Country [128]
0
0
Slovakia
Query!
State/province [128]
0
0
Nitra
Query!
Country [129]
0
0
Slovakia
Query!
State/province [129]
0
0
Nove Mesto nad Vahom
Query!
Country [130]
0
0
Slovakia
Query!
State/province [130]
0
0
Presov
Query!
Country [131]
0
0
South Africa
Query!
State/province [131]
0
0
Gauteng
Query!
Country [132]
0
0
South Africa
Query!
State/province [132]
0
0
Western CAPE
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Country [133]
0
0
Spain
Query!
State/province [133]
0
0
Barcelona
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Country [134]
0
0
Spain
Query!
State/province [134]
0
0
Madrid,
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Country [135]
0
0
Spain
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State/province [135]
0
0
Madrid
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Country [136]
0
0
Taiwan
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State/province [136]
0
0
Taipei City
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Country [137]
0
0
Ukraine
Query!
State/province [137]
0
0
Chernivtsi
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Country [138]
0
0
Ukraine
Query!
State/province [138]
0
0
Dnipropetrovsk
Query!
Country [139]
0
0
Ukraine
Query!
State/province [139]
0
0
Kharkiv
Query!
Country [140]
0
0
Ukraine
Query!
State/province [140]
0
0
Kyiv
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Country [141]
0
0
Ukraine
Query!
State/province [141]
0
0
Lviv
Query!
Country [142]
0
0
Ukraine
Query!
State/province [142]
0
0
Odesa
Query!
Country [143]
0
0
Ukraine
Query!
State/province [143]
0
0
Uzhgorod
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Country [144]
0
0
Ukraine
Query!
State/province [144]
0
0
Vinnytsia
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Country [145]
0
0
Ukraine
Query!
State/province [145]
0
0
Zaporizhzhia
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Country [146]
0
0
United Kingdom
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State/province [146]
0
0
England
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Country [147]
0
0
United Kingdom
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State/province [147]
0
0
Middlesex
Query!
Country [148]
0
0
United Kingdom
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State/province [148]
0
0
Norfolk
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Country [149]
0
0
United Kingdom
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State/province [149]
0
0
W1t 7ha
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is an open label, long-term extension study for subjects with moderate to severe
ulcerative colitis designed to evaluate long term therapy of CP-690,550.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01470612
Query!
Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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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
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Country
0
0
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Phone
0
0
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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/NCT01470612
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