A Randomized Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
18 Years
75 Years
Both
Crohn's Disease
Trial Information
A Randomized Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
Inclusion Criteria:
- Subjects who met study entry criteria, and who completed Week 8 visit of Induction
Study A3921083.
- Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or
clinical remission (CDAI<150) in Study A3921083.
- Women of childbearing potential must test negative for pregnancy prior to study
enrolment.
Exclusion Criteria:
- Subjects who had major protocol violation (as determined by the Sponsor) in the
A3921083 study.
- Subjects likely to require any type of surgery during the study period.
- Fecal culture/toxin assay indicating presence of pathogenic infection.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
The proportion of subjects maintaining clinical response-100, as defined by a decrease in CDAI score at least 100 points from A3921083 baseline, or being in clinical remission, as defined by a CDAI score less than 150, at Week 26.
Outcome Time Frame:
Week 26
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A3921084
NCT ID:
NCT01393899
Start Date:
March 2012
Completion Date:
April 2015
Related Keywords:
- Crohn's Disease
- Crohn Disease
Name | Location |
|---|---|
| University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536 |
| Shands Hospital at the University of Florida | Gainesville, Florida 32610 |
| Center for Digestive Health | Troy, Michigan 48098 |
| Digestive Health Specialists of Tyler | Tyler, Texas 75701 |
| Regional Gastroenterology Associates of Lancaster, Ltd. | Lancaster, Pennsylvania 17604 |
| Clinical Research Institute of Michigan, LLC | Chesterfield, Michigan 48047 |
| Southwest Gastroenterology | New Lenox, Illinois 60451 |
| Advanced Clinical Research Institute - Phase 1, LLC | Anaheim, California 92801 |
| AGMG Endoscopy Center | Anaheim, California 92801 |
| Shands Endoscopy Center | Gainesville, Florida 32608 |
| Shands Medical Plaza and Cancer Institute | Gainsville, Florida 32610 |
| Gastroenterology Group of Naples | Naples, Florida 34102 |
| Florida Medical Clinic, P.A. | Zephyrhills, Florida 33542 |
| Gastroenterology Associates of Central Georgia, LLC | Macon, Georgia 31201 |
| Surgical Centers of Michigan | Troy, Michigan 48098 |
| Utica Surgery Center | Utica, Michigan 48317 |
| Premier Medical Group of the Hudson Valley, PC | Poughkeepsie, New York 12601 |
| Charlotte Gastroenterology and Hepatology, PLLC | Charlotte, North Carolina 28207 |
| Charlotte Radiology | Charlotte, North Carolina 28277 |
| Dayton Gastroenterology, Inc. | Dayton, Ohio 45415 |
| Great Lakes Gastroenterology | Mentor, Ohio 44060 |
| Endoscopy Center of Tyler | Tyler, Texas 75701 |
| University of Utah HSC | Salt Lake City, Utah 84132 |
| Wisconsin Center for Advanced Research - GI Associates, LLC | Milwaukee, Wisconsin 53215 |
| Investigational Drug Service | Gainesville, Florida 32610 |
| Gastrointestinal and Liver Specialists | Norfolk, Virginia 23502 |
