A Multi-Center, Open-Label Study Of CP-690,550 In Subjects With Moderate To Severe Ulcerative Colitis
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Ulcerative Colitis
Both
Ulcerative Colitis
Trial Information
A Multi-Center, Open-Label Study Of CP-690,550 In Subjects With Moderate To Severe Ulcerative Colitis
Inclusion Criteria:
- Subjects who completed induction studies A3921094 or A3921095 and were classified as
not meeting clinical response criteria; OR
- Subjects who completed maintenance study A3921096 or who discontinued treatment early
in Study A3921096 due to treatment failure.
Exclusion Criteria:
- Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease.
- Subjects who have had surgery for ulcerative colitis or in the opinion of the
investigator, are likely to require surgery for ulcerative colitis during the study
period.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety measured by the number of reported adverse events
Outcome Time Frame:
12 months
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A3921139
NCT ID:
NCT01470612
Start Date:
October 2012
Completion Date:
December 2017
Related Keywords:
- Ulcerative Colitis
- Ulcerative colitis
- open-label
- long term treatment
- Colitis
- Colitis, Ulcerative
- Ulcer
Name | Location |
|---|---|
| Cedars Sinai Medical Center | Los Angeles, California 90048-1804 |
| Mayo Clinic | Rochester, Minnesota 55905 |
| Cedars-Sinai Medical Center | Los Angeles, California 90048 |
| Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
| Cleveland Clinic | Cleveland, Ohio 44195 |
| Atlanta Gastroenterology Associates | Atlanta, Georgia |
| Yale University School Of Medicine | New Haven, Connecticut 06520 |
| Florida Medical Clinic | Zephyrhills, Florida 33542 |
| UCSD Medical Center | La Jolla, California 92093 |
| University of California - San Francisco | San Francisco, California 94143 |
| Southern Clinical Research Consultants | Hollywood, Florida 33021 |
| Aga Clinical Research Associates, Llc | Egg Harbor Twp, New Jersey 08234 |
| LeBauer Research Associates, PA | Greensboro, North Carolina 27403 |
| Internal Medicine Specialists | Orlando, Florida 32806 |
| Horizon Research Group, Inc. | Mobile, Alabama 36608 |
| Wasatch Clinical Research | Salt Lake City, Utah 84107 |
| Center for Advanced Gastroenterology | Maitland, Florida 32751 |
| West Wind'r Research & Development, LLC | Tampa, Florida 33607 |
| Atlanta Center for Gastroenterology, P.C. | Decatur, Georgia 30033 |
| Center for Digestive Health | Troy, Michigan 48098 |
| The Gastroenterology Group of South Jersey | Vineland, New Jersey 08360 |
| 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 |
| Digestive Disease Associates, PA | Baltimore, Maryland 21229 |
| Gastrointestinal Diagnostic Center | Baltimore, Maryland 21229 |
| Howard County GIDC | Columbia, Maryland 21044 |
| Professional Quality Research, Inc. | Austin, Texas 78705 |
| Sharp Rees-Stealy Medical Group | San Diego, California 92101 |
| Desert Sun Clinical Research | Tucson, Arizona 85710 |
| Gastroenterology Group of Naples | Naples, Florida 34102 |
| Gastroenterology Associates of Central Georgia, LLC | Macon, Georgia 31201 |
| Great Lakes Gastroenterology | Mentor, Ohio 44060 |
| Wisconsin Center for Advanced Research - GI Associates, LLC | Milwaukee, Wisconsin 53215 |
| Internal Medicine Center, LLC | Mobile, Alabama 36608 |
| Springhill Memorial Hospital | Mobile, Alabama 36608 |
| Adobe Clinical Research, LLC | Tucson, Arizona 85712 |
| Desert Sun Surgery Center | Tucson, Arizona 85710 |
| Desert Sun Gastroenterology | Tucson, Arizona 85710 |
| Adobe Surgery Center | Tucson, Arizona 85712 |
| Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center | Los Angeles, California 90048 |
| Southern California Research Institute Medical Group, Inc - West Gastroenterology Medical Group | Los Angeles, California 90045 |
| West Gastroenterology Medical Group | Los Angeles, California 90813 |
| Alliance Clinical Research | Oceanside, California 92056 |
| Homan A Zadeh, MD, MPH | Palm Springs, California 92262 |
| Hope Square Surgical Center | Rancho Mirage, California 92270 |
| San Diego Endoscopy Center | San Diego, California 92103 |
| Endoscopy Center of Connecticut, LLC | Guilford, Connecticut 06437 |
| Gastroenterology Center of Connecticut, LLC | Hamden, Connecticut 06518 |
| Medical Research Center of Connecticut, LLC | Hamden, Connecticut 06518 |
| South Broway Endoscopy | Cooper City, Florida 33026 |
| MNH Surgical Center | Maitland, Florida 32751 |
| Citrus Ambulatory Surgery Center | Orlando, Florida 32806 |
| Endoscopy Center | Port Orange, Florida 32127 |
| Advanced Medical Research Center | Port Orange, Florida 32127 |
| Advanced Gastroenterology Center | Port Orange, Florida 32127 |
| Port Orange Urgent Care | Port Orange, Florida 32127 |
| Georgia Endoscopy Center | Alpharetta, Georgia 30005 |
| Cardiovascular Specialist | Atlanta, Georgia 30342 |
| Atlanta Gastroenterology Associates LLC | Atlanta, Georgia 30342 |
| Atlanta Gastroenterology Associates, LLC. | Atlanta, Georgia 30342 |
| GI Consultants | Atlanta, Georgia 30342 |
| Emory Healthcare Heart Center | Johns Creek, Georgia 30097 |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka, Kansas 66606 |
| Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research | Chevy Chase, Maryland 20815 |
| University of Michigan Health Systems - A. Alfred Taubman Health Care Center | Ann Arbor, Michigan 48109-5000 |
| Surgery Center of Columbia | Columbia, Missouri 65201 |
| Hannibal Regional Hospital | Hannibal, Missouri 63401 |
| Audrian Medical Center | Mexico, Missouri 65265 |
| Center for Digestive & Liver Disease, Inc. | Mexico, Missouri 65265 |
| South Jersey Gastroenterology | Marlton, New Jersey 08053 |
| Long Island Clinical Research Associates, LLP | Great Neck, New York 11021 |
| Nassau Gastroenterology Associates, PC | Great Neck, New York 11021 |
| Nassau Gastroenterology Associates | Great Neck, New York 11021 |
| LeBauer Endoscopy Center | Greensboro, North Carolina 27403 |
| LeBauer HealthCare | Greensboro, North Carolina 27403 |
| Carolina Research - Carolina Digestive Diseases | Greenville, North Carolina 27834 |
| Donald Guthrie Foundation for Education and Research | Sayre, Pennsylvania 18840 |
| Associates in Gastroenteroogy | Hermitage, Tennessee 37076 |
| Hermitage Imaging | Hermitage, Tennessee 37076 |
| Associated Endoscopy | Hermitage, Tennessee 37076 |
| Austin Gastroenterology PA/Austin Endoscopy Center II | Austin, Texas 78745 |
| Gastroenterology Consultants, P.A. | Houston, Texas 77034 |
| Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center | Pasadena, Texas 77505 |
| Wasatch Endoscopy Center | Salt Lake City, Utah 84124 |
| Alpine Medical Group | Salt Lake City, Utah 84102 |
| Center for Digestive Health | Milwaukee, Wisconsin 53215 |
