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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT01393626

A3921083

2011-001733-16 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 280 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 3 patient groups, including a placebo group

Placebo BID

Placebo Comparator group

Treatment:

Drug: Placebo

5mg BID

Experimental group

Treatment:

Drug: CP-690,550

10mg BID

Experimental group

Treatment:

Drug: CP-690,550