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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Naples, Florida 34102
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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
2513
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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
2549
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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...
703
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Salt Lake City, UT
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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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Anaheim, California 92801
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Charlotte, North Carolina 28207
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Charlotte, North Carolina 28277
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Chesterfield, Michigan 48098
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Chevy Chase, Maryland 20815
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Clearwater, Florida 33756
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Clive, IA
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Clive, Iowa 50325
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Dayton, Ohio 45415
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Gainesville, Florida 32610
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Gainesville, Florida 32608
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Guilford, Connecticut 06437
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Hamden, Connecticut 06518
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Hamden, Connecticut 06518
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Houston, Texas 77070
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Houston, Texas 77030
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Huntersville, North Carolina 28078
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Inverness, Florida 34452
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lexington, KY
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Maitland, Florida 32751
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Mentor, Ohio 44060
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Milwaukee, Wisconsin 53215
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Miramar, Florida 33025
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Norfolk, Virginia 23502
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Oak Lawn, Illinois 60453
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Oceanside, California 92056
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Poway, California 92064
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Virginia Beach, Virginia 23455
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Wauwatosa, Wisconsin 53226
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Wauwatosa, Wisconsin 53226
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Willoughby, Ohio 44094
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Zephyrhills, Florida 33542
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