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

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
ACRI - Phase 1, LLC
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Crohn's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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-TNF? 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.

NCT01393626
Pfizer
Completed
A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

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[email protected]

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1-800-718-1021

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