The Safety And Efficacy Of Maintenance Therapy With CP-690,550

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 who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI\<150) at Week 8.

Key facts

Study ID

NCT01393899

Run by

Pfizer

People needed

180

Starts

2012-03-01

Expected to finish

2015-07-01

Last updated by the study team

2017-01-09

Who can join

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

You may qualify if…

• Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
• Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083.
• Women of childbearing potential must test negative for pregnancy prior to study enrolment.

You may not qualify if…

• Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
• Subjects likely to require any type of surgery during the study period.
• Fecal culture/toxin assay indicating presence of pathogenic infection.

Where it is running

• ACRI - Phase I, LLC — Anaheim, California, United States
• Advanced Clinical Research Institute-Phase 1, LLC — Anaheim, California, United States
• West Coast Clinical Trials — Cypress, California, United States
• Alliance Clinical Research — Oceanside, California, United States
• Clinical Research Of The Rockies — Lafayette, Colorado, 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
• Shands Endoscopy Center — Gainesville, Florida, United States
• Shands Hospital at the University of Florida — Gainesville, Florida, United States
• Shands Medical Plaza and Cancer Center — Gainesville, Florida, United States
• University of Florida - College of Medicine — Gainsville, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Gulfshore Endoscopy Center (Endoscopies Only) — Naples, Florida, United States
• North Florida Gastroenterology Research, LLC — Orange Park, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• Gastroenterology Associates of Central Georgia, LLC — Macon, Georgia, United States
• Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
• Chevy Chase Endoscopy Center — Chevy Chase, Maryland, United States
• Metropolitan Gastroenterology Group, PC — Chevy Chase, Maryland, United States
• East Ann Arbor Health and Geriatrics Center — Ann Arbor, Michigan, United States
• University of Michigan Health Systems — Ann Arbor, Michigan, United States
• Center for Digestive Health — Troy, Michigan, United States
• Surgical Centers of Michigan — Troy, Michigan, United States
• ACMG Endoscopy Center — Anaheim, California, United States

Full record on ClinicalTrials.gov

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