A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

Key facts

Study ID

NCT01458574

Run by

Pfizer

People needed

593

Starts

2012-07-20

Expected to finish

2016-05-27

Last updated by the study team

2017-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
• Subjects who achieved clinical response in Study A3921094 or A3921095
• Women of childbearing potential must test negative for pregnancy prior to study enrollment
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
• Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

You may not qualify if…

• Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
• Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
• Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.

Where it is running

• Springhill Memorial Hospital (Endoscopy Only) — Mobile, Alabama, United States
• UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center — La Jolla, California, United States
• UCSD Medical Center — La Jolla, California, United States
• Alliance Clinical Research — Oceanside, California, United States
• Desert Advanced Imaging — Palm Springs, California, United States
• Erik Palmer, DO — Palm Springs, California, United States
• Homan A Zadeh, MD, MPH — Palm Springs, California, United States
• Hope Square Surgical Center — Rancho Mirage, California, United States
• Sharp Rees-Stealy Medical Group, Inc. — San Diego, California, United States
• Clinical Applications Laboratories, Inc — San Diego, California, United States
• San Diego Endoscopy Center — San Diego, California, United States
• Sharp Rees-Stealy Medical Group — San Diego, California, United States
• UCSF Endoscopy Unit at Mount Zion — San Francisco, California, United States
• University of California San Francisco — San Francisco, California, United States
• Bristol Hospital — Bristol, Connecticut, United States
• Connecticut Clinical Research Foundation — Bristol, Connecticut, 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
• Central Connecticut Endoscopy Center — Plainville, Connecticut, United States
• Citrus Surgery & Endoscopy Center (colonoscopy) — Crystal River, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Suncoast Endoscopy Center (colonoscopy) — Inverness, Florida, United States
• Internal Medicine Center, LLC — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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