A Study To Monitor Long-Term Treatment With PF-00547659

Completed · Phase 2

Conditions studied: Crohn's Disease

In brief

This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.

Key facts

Study ID

NCT01298492

Run by

Shire

People needed

268

Starts

2011-07-01

Expected to finish

2016-07-27

Last updated by the study team

2021-06-03

Who can join

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

You may qualify if…

• Subjects between 18 and 76 years of age.
• Subjects previously enrolled in study A7281006 who have completed the blinded 84 day (12 week) induction period or in study A7281008 who have completed Week 12 and have demonstrated a clinical response as defined by that protocol.

You may not qualify if…

• Subjects that have completed Day 84 (Week 12) of a PF-00547659 study but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would hinder entry or participation in this study.
• Subjects who are taking any dose of azathioprine, 6-mercaptopurine or methotrexate.

Where it is running

• Community Clinical Trials — Orange, California, United States
• GastroDiagnostics — Orange, California, United States
• Clinical Research of the Rockies — Lafayette, Colorado, United States
• Rmga - Rmcr — Thornton, Colorado, United States
• Rocky Mountain Gastroenterology Associates — Thornton, Colorado, United States
• MGG Group Co., Inc. — Washington D.C., District of Columbia, United States
• Florida Center for Gastroenterology — Largo, Florida, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• University of Miami Crohn's and Colitis Center — Miami, Florida, United States
• University of Miami Hospital and Clinic (IP Shipment Only) — Miami, Florida, United States
• University of Miami Hospital and Clinic — Miami, Florida, United States
• University of Miami Hospital — Miami, Florida, United States
• Citrus Ambulatory Surgery Center — Orlando, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• Heartland Medical Research, Inc. — Clive, Iowa, United States
• Iowa Digestive Disease Center — Clive, Iowa, United States
• Iowa Endoscopy Center (Colonoscopy Only) — Clive, Iowa, United States
• Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• University of Massachusetts Worcester — Worcester, Massachusetts, United States
• Center for Digestive Health — Troy, Michigan, United States
• Surgical Centers of Michigan — Troy, Michigan, United States
• Surgery Center of Columbia — Columbia, Missouri, United States
• Audrain Medical Center — Mexico, Missouri, United States
• UCSD Medical Center - Thorton Hospital — La Jolla, California, United States

Full record on ClinicalTrials.gov

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