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
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:7/11/2015
Start Date:October 2011
End Date:February 2015
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Study To Investigate The Safety And Efficacy Of Cp-690,550 For Induction 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. The study hypothesis is that at least one dose of the tested drug is
more effective than placebo (inactive drug).


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.
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260 Lookout Pl # 201
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201 Presidents Circle
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1 Medical Center Dr
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