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

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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).

Key facts

Study ID

NCT01393626

Run by

Pfizer

People needed

280

Starts

2011-10-01

Expected to finish

2015-03-01

Last updated by the study team

2017-04-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Advanced Clinical Research Institute - Phase 1, LLC — Anaheim, California, United States
• AGMG Endoscopy Center — Anaheim, California, United States
• Alliance Clinical Research — Oceanside, California, United States
• Alliance Clinical Research, LLC — Poway, California, United States
• Sharp Rees-Stealy Medical Group, Inc. — San Diego, California, United States
• Sharp Rees-Stealy Medical Group, Inc. — San Diego, California, United States
• Clinical Research Of The Rockies — Lafayette, Colorado, United States
• Endoscopy Center of the Rockies - Longmont — Longmont, Colorado, United States
• Endoscopy Center of Connecticut, LLC — Guilford, Connecticut, United States
• Endoscopy Center of Connecticut, LLC — Hamden, Connecticut, United States
• Gastroenterology Center of Connecticut, PC — Hamden, Connecticut, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• Metropolitan Gastroenterology Group, PC — Washington D.C., District of Columbia, United States
• Gasteroenterology Consultants of Clearwater — Clearwater, Florida, United States
• West Coast Endoscopy Center — Clearwater, Florida, United States
• Clinical Research of West Florida, Inc — Clearwater, Florida, United States
• Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only) — Crystal River, Florida, United States
• Shands Endoscopy Center — Gainesville, Florida, United States
• Shands Hospital at the University of Florida — Gainesville, Florida, United States
• Investigational Drug Service — Gainesville, Florida, United States
• Shands Medical Plaza and Cancer Center — Gainesville, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Suncoast Endoscopy Center (Colonoscopy Only) — Inverness, Florida, United States
• FQL Research, LLC — Miramar, Florida, United States
• ACRI - Phase 1, LLC — Anaheim, California, United States

Full record on ClinicalTrials.gov

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