A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.

Key facts

Study ID

NCT01287897

Run by

Pfizer

People needed

250

Starts

2011-02-01

Expected to finish

2015-02-01

Last updated by the study team

2016-01-21

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
• hsCRP greater or equal to 5.0 mg/L
• Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed within 8 weeks of study entry (screening) and able to retrospectively complete the SES-CD or colonoscopy performed during screening

You may not qualify if…

• Pregnant or breastfeeding women
• Crohn's Disease with active fistulae or abscess
• History of diverticulitis or symptomatic diverticulosis
• Abnormality in hematology or chemistry profiles at screening

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Simon Medical Imaging — Scottsdale, Arizona, United States
• Digestive Health Research Unit — Scottsdale, Arizona, United States
• Adobe Clinical Research, Llc — Tucson, Arizona, United States
• Radiology Ltd — Tucson, Arizona, United States
• UCSF Endoscopy Unit at Mount Zion — San Francisco, California, United States
• University of California - San Francisco — San Francisco, California, United States
• University of California San Francisco at Mount Zion — San Francisco, California, United States
• Rocky Mountain Clinical Research, LLC — Denver, Colorado, United States
• Rocky Mountain Gastroenterology Associates — Lakewood, Colorado, United States
• Rocky Mountain Gastroenterology — Lakewood, Colorado, United States
• Arapahoe Gastroenterology, PC — Littleton, 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
• 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
• Advanced Research Institute, Inc. — New Port Richey, Florida, United States
• International Clinical Research - US, LLC — Sanford, Florida, United States
• Atlanta Center for Gastroenterology, P.C. — Decatur, Georgia, United States
• Atlanta Endoscopy Center — Decatur, Georgia, United States
• UAB Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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