B0151005 Open-Label Extension Study

Completed · Phase 2

Conditions studied: Crohn's Disease

In brief

This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.

Key facts

Study ID

NCT01345318

Run by

Pfizer

People needed

191

Starts

2011-06-01

Expected to finish

2016-03-01

Last updated by the study team

2024-01-12

Who can join

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

You may qualify if…

• Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12 week) induction period.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Women of childbearing potential, who have sexual intercourse with a non surgically sterilized male partner, must agree and commit to the use highly effective methods of birth control from signing of the ICD through 26 weeks after the Final Study Evaluation or for 62 weeks from the last dose of investigational product for any subject who terminates early from this study.

You may not qualify if…

• Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or inclusion in this study.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate entry into this study.
• Received any prohibited treatment during study B0151003 that, in the opinion of the investigator, compromised the safety or efficacy of this study.

Where it is running

• Digestive Health Research Unit — Scottsdale, Arizona, United States
• Adobe Clinical Research, LLC — Tucson, Arizona, United States
• Adobe Surgery Center — Tucson, Arizona, United States
• Rocky Mountain Gastroenterology Associates — Lakewood, Colorado, United States
• Rocky Mountain Gastroenterology — Littleton, Colorado, United States
• Rocky Mountain Clinical Research, LLC. — Wheat Ridge, Colorado, United States
• Rocky Mountain Clinical Research, LLC — Wheat Ridge, Colorado, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• Gastroenterology Consultants of Clearwater — Clearwater, Florida, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• Gastroenterology Associates — Crystal River, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Suncoast Endoscopy Center — Inverness, Florida, United States
• International Clinical Research - US, LLC — Sanford, Florida, United States
• Atlanta Center for Gastroenterology, P.C. — Decatur, Georgia, United States
• The Atlanta Center For Gastroenterology — Decatur, Georgia, United States
• Gastointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Illinois Gastroenterology Group, LLC — Arlington Heights, Illinois, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• U of L Health Care Outpatient Center — Louisville, Kentucky, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Digestive Disorders Associates — Annapolis, Maryland, United States
• Simon Medical Imaging — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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