A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01393626
• Date of registration: 11/07/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
• Date of first enrolment: October 2011
• Target sample size: 280
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01393626
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Japan, Korea, Republic of, Netherlands, Romania, South Africa, Spain, Sweden, Ukraine, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects between the ages of 18 and 75 years at screening (upper age
limit will be 64 years in India and 65 years in the Netherlands).

- Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to
screening.

- Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a
baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.

Exclusion Criteria:

- Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings
suggestive of UC.

- Subjects diagnosed with Crohn's disease but without previous exposure to treatment
(i.e., treatment-naïve).

- Subjects receiving the following treatment for Crohn's disease:

- Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.

- Anti-TNFa therapy within 8 weeks prior to baseline.

- Interferon therapy within 8 weeks prior to baseline.

- Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.

- Intravenous corticosteroids within 2 weeks prior to baseline.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: CP-690,550

Drug: Placebo

Primary Outcome(s)

Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8 [Time Frame: Week 8]

Secondary Outcome(s)

EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit [Time Frame: Baseline, Week 8/ET visit]

Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 [Time Frame: Weeks 2 and 4]

EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit [Time Frame: Baseline, Week 8/ET visit]

Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit [Time Frame: Baseline, Week 8/ET visit]

Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA [Time Frame: Baseline, Week 8/ET visit]

Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points From Baseline) at Weeks 2, 4, and 8 [Time Frame: Baseline, Weeks 2, 4, and 8]

Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 [Time Frame: Weeks 2, 4, and 8]

Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points From Baseline) at Weeks 2, 4, and 8 [Time Frame: Baseline, Weeks 2, 4, and 8]

Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 [Time Frame: Baseline, Weeks 2, 4, and 8]

Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category [Time Frame: Week 8/ET visit]

Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA [Time Frame: Baseline, Week 8/ET visit]

Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit [Time Frame: Baseline, Week 8/ET visit]

Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit [Time Frame: Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit]

C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8 [Time Frame: Weeks 2, 4, and 8]

Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA) [Time Frame: Baseline, Week 8/ET visit]

Percentage of Participants With =16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit [Time Frame: Week 8/ET visit]

Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (=) 170 at Week 8/ET Visit [Time Frame: Week 8/ET visit]

CDAI Scores at Weeks 2, 4, and 8 [Time Frame: Weeks 2, 4, and 8]

Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA [Time Frame: Baseline, Week 8/ET visit]

Secondary ID(s)

A3921083

2011-001733-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01393626