The Safety And Efficacy Of Maintenance Therapy With CP-690,550
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | March 2012 |
| End Date: | July 2015 |
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
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.
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.
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.
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.
We found this trial at
41
sites
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Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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