A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients 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

NCT00615199

A3921043

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 of the dose levels to be tested will be more effective than placebo (inactive drug).

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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139 participants in 4 patient groups, including a placebo group

1mg BD

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

5mg BD

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

15mg BD

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Placebo BID

Placebo Comparator group

Treatment:

Drug: Placebo