Phase 2
N=139
A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00615199 ↗Enrolled (actual)
139
Serious AEs
10.1%
Results posted
Dec 2012
Primary outcome: Primary: Number of Participants With Clinical Response 70 at Week 4 — 14; 13; 18; 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CP-690,550 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Response 70 at Week 4 |
14; 13; 18; 16 | — |
| SECONDARY Number of Participants With Clinical Response 70 at Week 1 and 2 |
12; 9; 11; 9; 10; 15 | — |
| SECONDARY Number of Participants Achieving Clinical Remission at Week 4 |
7; 11; 8; 5 | — |
| SECONDARY Number of Participants With Clinical Response 100 at Week 4 |
9; 11; 14; 13 | — |
| SECONDARY Time to First Clinical Remission |
NA; NA; 30.0; NA | — |
| SECONDARY Time to First Response 70 |
29.0; 30.0; 21.0; 29.0 | — |
| SECONDARY Time to First Response 100 |
NA; 30.0; 30.0; NA | — |
Summary
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).
Eligibility Criteria
Inclusion Criteria
- Subjects must be at least 18 years of age at screening
- Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
- Subjects with moderate to severe Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive
Exclusion Criteria
- Subjects currently receiving immunosuppressants, interferon, anti-TNFa
- Subjects with evidence of hematopoietic disorders
- Subjects with evidence of active or latent TB
Data sourced from ClinicalTrials.gov (NCT00615199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.