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.
We found this trial at
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1600 SW Archer Rd # M509
Gainesville, Florida 32610
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610 3rd St # 206
Macon, Georgia 31201
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260 Lookout Pl # 201
Maitland, Florida 32751
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Orlando, Florida 32806
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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Anaheim, California 92801
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Charlotte, North Carolina 28207
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Chesterfield, Michigan 48098
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Clearwater, Florida 33756
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
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Clive, Iowa 50325
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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