Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

Key facts

Study ID

NCT01276509

Run by

Shire

People needed

265

Starts

2011-04-06

Expected to finish

2015-10-09

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 must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
• hsCRP greater than 3mg/L
• Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening

You may not qualify if…

• Pregnant or breast feeding
• Short bowel syndrome due to multiple small bowel resections
• Presence of a stoma

Where it is running

• Gastroenterology Specialists of Arkansas — Jonesboro, Arkansas, United States
• Little Rock Diagnostic Clinic, P.A. — Little Rock, Arkansas, United States
• UCSD Medical Center-Thornton Hospital — La Jolla, California, United States
• Community Clinical Trials — Orange, California, United States
• Gastro Diagnostics — Orange, California, United States
• Inland Gastroenterology Medical Associates, Inc. — Redlands, California, United States
• BioMark Research Inc. — Whittier, California, United States
• Clinical Research of the Rockies — Lafayette, Colorado, United States
• Rocky Mountain Gastroenterology Associates — Thornton, Colorado, United States
• Connecticut Clinical Research Foundation — Bristol, Connecticut, United States
• Shands Endoscopy Center — Gainesville, Florida, United States
• Shands Hospital at the University of Florida — Gainesville, Florida, United States
• Shands Medical Plaza — Gainesville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Florida Center for Gastroenterology — Largo, Florida, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• University of Miami Hospital and Clinic — Miami, Florida, United States
• University of Miami Hospital — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Cirtus Ambulartory Surgery Center — Orlando, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• Heartland Medical Research (Administrative Only) — Clive, Iowa, United States
• Iowa Digestive Disease Center — Clive, Iowa, United States
• Iowa Endoscopy Center (Colonoscopy Only) — Clive, Iowa, United States
• Clopton Clinic — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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