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

• Status: Completed
• Trial end date: 2015-03-01
• 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. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).

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

Details

• Lead Sponsor: Pfizer
• Treatments: Tofacitinib

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-TNFα 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.