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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/NCT01393899
Registration number
NCT01393899
Ethics application status
Date submitted
12/07/2011
Date registered
13/07/2011
Date last updated
9/01/2017
Titles & IDs
Public title
The Safety And Efficacy Of Maintenance Therapy With CP-690,550
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
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Secondary ID [1]
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2011-001754-28
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Secondary ID [2]
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A3921084
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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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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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Placebo Comparator: Placebo BID -
Experimental: 5mg BID -
Experimental: 10mg BID -
Treatment: Drugs: Placebo
oral tablets twice daily
Treatment: Drugs: CP-690,550
oral tablets twice daily
Treatment: Drugs: CP-690,550
oral tablets twice daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26
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Assessment method [1]
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Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
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Timepoint [1]
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Week 26
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Secondary outcome [1]
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Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20
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Assessment method [1]
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Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [1]
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Weeks 4, 8, 12 and 20
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Secondary outcome [2]
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Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26
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Assessment method [2]
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Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [2]
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Weeks 4, 8, 12, 20 and 26
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Secondary outcome [3]
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Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26
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Assessment method [3]
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Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [3]
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Weeks 4, 8, 12, 20 and 26
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Secondary outcome [4]
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Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study
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Assessment method [4]
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Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [4]
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Weeks 4, 8, 12, 20 and 26
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Secondary outcome [5]
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Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase
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Assessment method [5]
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Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [5]
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Weeks 20 and 26
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Secondary outcome [6]
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Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase
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Assessment method [6]
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Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [6]
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Weeks 20 and 26
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Secondary outcome [7]
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CDAI Score by Week
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Assessment method [7]
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CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity
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Timepoint [7]
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Baseline and Weeks 4, 8, 12, 20 and 26
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Secondary outcome [8]
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Change From Baseline in CDAI Score by Week
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Assessment method [8]
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CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity
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Timepoint [8]
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Weeks 4, 8, 12, 20 and 26
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Secondary outcome [9]
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Kaplan-Meier Estimate of the Rate of Time to Relapse
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Assessment method [9]
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Time to relapse was defined as increase in CDAI of more than (>)100 points from the maintenance phase baseline and a CDAI score of >220 points, or an increase to or above the baseline CDAI score in A3921083. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [9]
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Weeks 4, 8 12, 20 and 26
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Secondary outcome [10]
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Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline
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Assessment method [10]
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Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body eight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [10]
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Week 26
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Secondary outcome [11]
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C-Reactive Protein (CRP) by Week
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Assessment method [11]
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
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Timepoint [11]
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Baseline and Weeks 4, 8, 12, 20 and 26
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Secondary outcome [12]
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Change From Baseline in CRP by Week
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Assessment method [12]
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
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Timepoint [12]
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Weeks 4, 8, 12, 20 and 26
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Secondary outcome [13]
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Fecal Calprotectin by Week
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Assessment method [13]
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Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
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Timepoint [13]
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Baseline and Weeks 8, 12 and 26
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Secondary outcome [14]
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Change From Baseline in Fecal Calprotectin by Week
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Assessment method [14]
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Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
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Timepoint [14]
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Weeks 8, 12 and 26
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Secondary outcome [15]
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Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose
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Assessment method [15]
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Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.
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Timepoint [15]
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Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit
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Eligibility
Key inclusion criteria
- Subjects who met study entry criteria, and who completed Week 8 visit of Induction
Study A3921083.
- Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or
clinical remission (CDAI<150) in Study A3921083.
- Women of childbearing potential must test negative for pregnancy prior to study
enrolment.
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Minimum age
18
Years
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Maximum age
75
Years
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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 major protocol violation (as determined by the Sponsor) in the
A3921083 study.
- Subjects likely to require any type of surgery during the study period.
- Fecal culture/toxin assay indicating presence of pathogenic infection.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
1/03/2012
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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
1/07/2015
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Sample size
Target
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Accrual to date
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Final
180
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Nepean Public Hospital - Kingswood
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Recruitment hospital [2]
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Monash Medical Centre - Clayton
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Recruitment hospital [3]
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Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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2747 - Kingswood
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3050 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Colorado
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United States of America
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Florida
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Country [4]
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United States of America
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Georgia
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Country [5]
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United States of America
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State/province [5]
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Kansas
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Country [6]
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United States of America
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Maryland
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Country [7]
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United States of America
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Michigan
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Country [8]
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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Wisconsin
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Country [14]
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Austria
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State/province [14]
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Wien
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Country [15]
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Bulgaria
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Sofia
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Canada
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British Columbia
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Country [17]
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Canada
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Ontario
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Country [18]
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Canada
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Quebec
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Country [19]
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Czech Republic
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Hradec Kralove
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Country [20]
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Czech Republic
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Hradec Králové
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France
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Lille Cedex
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France
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Pessac Cedex
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Germany
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Berlin
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Germany
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Kiel
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Germany
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Ulm
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Greece
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Kolonaki Athens
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Hungary
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Budapest
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Hungary
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State/province [28]
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Gyongyos
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Hungary
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Kaposvár
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Hungary
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Szekszard
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Israel
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State/province [31]
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Tel -Aviv
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Japan
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Hyogo
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Japan
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Miyagi
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Japan
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Chiba
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Japan
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Hokkaido
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Japan
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Osaka
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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South Africa
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Western Cape
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South Africa
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Durban
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Spain
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Barcelona
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Spain
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Madrid
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Ukraine
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Donetsk
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Ukraine
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Odesa
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Country [47]
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Ukraine
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State/province [47]
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Vinnitsa
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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 investigates safety and efficacy of CP-690,550 in adult patients with moderate to
severe Crohn's disease who completed the double-blind induction treatment in Study A3921083
and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01393899
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01393899
Download to PDF