The Safety And Efficacy Of Maintenance Therapy With CP-690,550

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Tofacitinib

Criteria

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.