A Study of Abatacept in Patients With Active Ulcerative Colitis

Condition(s) targeted: Ulcerative Colitis

Intervention: abatacept (Drug); placebo (Drug); abatacept (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied

Official title: A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Ulcerative Colitis (UC) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome:

Compare proportion of subjects in response (reduction from baseline in Mayo score ≥ 3 pts and ≥ 30%, also with decrease from baseline in rectal bleeding subscore ≥ 1 pt or absolute rectal bleeding subscore ≤ 1 pt) at Wk 12 between abatacept and placebo

Compare proportion of subjects in response (reduction from baseline in Mayo score ≥3 pts and ≥30%, also with decrease from baseline in rectal bleeding subscore ≥1 pt or absolute rectal bleeding subscore of ≤1) at Month 12 between abatacept and placebo

Assess the long-term clinical safety and tolerability of abatacept treatment during the Open-Label Extension Phase

Secondary outcome:

Compare the proportion of subjects in clinical remission (defined as Mayo score ≤ 2 points and no individual subscore exceeding 1 point) at Week 12 between the abatacept and placebo treatment regimens

Compare the proportion of subjects with mucosal healing (defined as endoscopic subscore ≤ 1 point) at Week 12 between the abatacept and placebo treatment regimens

Evaluate the dose-response relationship by comparing the proportions of subjects in clinical response at Week 12 induced by placebo and abatacept in increasing doses (3 mg/kg, ~10 mg/kg, 30/~10 mg/kg)

Assess in abatacept vs placebo treated subjects improvements in quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score at Week 12

Assess the proportion of abatacept vs placebo treated subjects with Mayo subscores (rectal bleeding, stool frequency, physician's global assessment) indicative of mild disease (individual subscore ≤ 1) at Week 12

Evaluate in subjects with inadequate response and/or intolerance to anti TNFs, the dose-response relationship by comparing the proportions of subjects in clinical response at Wk 12 induced by placebo and abatacept in increasing doses (3,~10, 30/~10mg/kg)

Assess in abatacept vs placebo treated subjects who have had an inadequate response and/or intolerance to anti-TNF therapy, a) the proportion in clinical response, b) the proportion in remission, and c) the proportion with mucosal healing at Weeks 12

Assess the immunogenicity of abatacept in subjects with UC

Assess the tolerability and safety of abatacept in subjects with UC

Compare the proportion of subjects who are in clinical remission (defined as a Mayo score ≤ 2 points and no individual subscore exceeding 1 point) at Month 12 between the abatacept and placebo treatment regimens

Compare the proportion of subjects with mucosal healing (defined as endoscopic subscore ≤ 1) at Month 12 between the abatacept and placebo treatment regimens

Compare the proportion of subjects who are in clinical remission at both Month 6 (Day MP-169) and Month 12 between the abatacept and placebo treatment regimens

Compare the proportion of subjects using oral corticosteroids at baseline who have discontinued corticosteroids and are in remission at Month 12 between the abatacept and placebo treatment regimens

Assess in abatacept vs placebo treated subjects improvements in quality of life as measured by a) the IBDQ score and b) the Short Form-36 (SF-36) at Month 12

Assess the proportion of abatacept versus placebo treated subjects using oral corticosteroids at baseline who have discontinued corticosteroids for at least 90 consecutive days and are in remission at Month 12

Assess the proportion of abatacept versus placebo treated subjects with Mayo subscores (rectal bleeding, stool frequency, physician's global assessment) indicative of mild disease (individual subscore ≤ 1) at Month 12

Assess in abatacept versus placebo treated-subjects who have had an inadequate response and/or intolerance to anti-TNF therapy a) the proportion in clinical response, b) the proportion in remission, and c) the proportion with mucosal healing at Month 12

Assess the immunogenicity of abatacept in subjects with UC

Assess the tolerability and safety of abatacept in subjects with UC

Assess durability of clinical efficacy (clinical response and remission), clinical efficacy upon retreatment, immunogenicity, and corticosteroid use

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men or women 18 years or older

- Ulcerative colitis for at lease 3 months

- Moderate to severe active ulcerative colitis

- Inadequate response or intolerance to standard ulcerative colitis treatment

For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

Local Institution, Leuven 3000, Belgium; Recruiting
Site 138

Local Institution, Bruxelles 1200, Belgium; Completed

Local Institution, Rio De Janeiro 21941, Brazil; Recruiting
Site 175

Local Institution, Sao Paulo 01246, Brazil; Recruiting
Site 178

Local Institution, Quebec G1L 3L5, Canada; Recruiting
Site 009

Local Institution, Brno - Bohunice 625 00, Czech Republic; Not yet recruiting
Site 165

Local Institution, Ceske Budejovice 370 87, Czech Republic; Recruiting
Site 203

Local Institution, Clichy 92110, France; Recruiting
Site 084

Local Institution, Lille Cedex 59037, France; Recruiting
Site 085

Local Institution, Pessac 33604, France; Recruiting
Site 086

Local Institution, Toulouse 31059, France; Completed

Local Institution, Nice 06200, France; Recruiting
Site 089

Local Institution, Paris 75475, France; Recruiting
Site 096

Local Institution, Amiens Cedex 1 80054, France; Recruiting
Site 189

Local Institution, Muenster 48159, Germany; Recruiting
Site 006

Local Institution, Muenster 48129, Germany; Recruiting
Site 059

Local Institution, Kiel 24105, Germany; Recruiting
Site 172

Local Institution, Hyderabad 500058, India; Recruiting
Site 050

Local Institution, Mumbai 400 029, India; Recruiting
Site 081

Local Institution, Mumbai 400 022, India; Not yet recruiting
Site 082

Local Institution, Bangalore 560017, India; Recruiting
Site 094

Local Institution, Manipal 576104, India; Recruiting
Site 117

Local Institution, Mangalore 575001, India; Recruiting
Site 118

Local Institution, Delhi 110076, India; Not yet recruiting
Site 168

Local Institution, Bangalore 560034, India; Not yet recruiting
Site 220

Local Institution, Mysore 570004, India; Recruiting
Site 225

Local Institution, Dublin, Ireland; Recruiting
Site 139

Local Institution, Napoli 80138, Italy; Recruiting
Site 158

Local Institution, Roma 00152, Italy; Recruiting
Site 159

Local Institution, San Giovanni Rotondo 71013, Italy; Recruiting
Site 160

Local Institution, Padova 35128, Italy; Recruiting
Site 161

Local Institution, Roma 00133, Italy; Recruiting
Site 162

Local Institution, Seoul 120-752, Korea, Republic of; Recruiting
Site 180

Local Institution, Chihuahua 31238, Mexico; Recruiting
Site 132

Local Institution, Amersfoort 3816 CP, Netherlands; Recruiting
Site 107

Local Institution, Groningen 9700 RB, Netherlands; Not yet recruiting
Site 205

Local Institution, Amsterdam 1105 AZ, Netherlands; Recruiting
Site 212

Local Institution, Warszawa 02-781, Poland; Recruiting
Site 142

Local Institution, Katowice 40-752, Poland; Recruiting
Site 144

Local Institution, Wroclaw 50-326, Poland; Recruiting
Site 146

Local Institution, Ponce 00716, Puerto Rico; Recruiting
Site 171

Local Institution, Zuerich 8091, Switzerland; Recruiting
Site 108

Local Institution, Bern 3010, Switzerland; Recruiting
Site 111

University Of Alabama At Birmingham, Birmingham, Alabama 35294, United States; Recruiting
Alexandra Gutierrez, Site 190

Local Institution, Hyderabad, Andhra Pradesh 500082, India; Recruiting
Site 183

Mayo Clinic Arizona, Scottsdale, Arizona 85259, United States; Recruiting
Jonathan A. Leighton, Site 155

Local Institution, Garran, Australian Capital Territory 2605, Australia; Active, not recruiting

Local Institution, Salvador, Bahia 42700, Brazil; Recruiting
Site 182

Local Institution, Vancouver, British Columbia V6Z 2K5, Canada; Recruiting
Site 065

Local Institution, Vancouver, British Columbia V5Z 1H2, Canada; Recruiting
Site 206

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Gil Melmed, Site 068, Phone: 310-423-7725

The Permanente Medical Group, Inc, Sacramento, California 95825, United States; Recruiting
Michael Lawson, Site 127

Local Institution, Torreon, Coahuila 27250, Mexico; Recruiting
Site 021

Western States Clinical Research Inc., Wheatridge, Colorado 80033, United States; Completed

Litchfield County Gastroenterology Assoc., Torrington, Connecticut 06790, United States; Terminated

Local Institution, Mexico, Distrito Federal 14080, Mexico; Recruiting
Site 025

Local Institution, Df, Distrito Federal 11560, Mexico; Recruiting
Site 133

Local Institution, Mexico, D. F., Distrito Federal 06726, Mexico; Recruiting
Site 211

Local Institution, Dublin 9, Dublin, Ireland; Recruiting
Site 129

Miami Research Associates, Miami, Florida 33143, United States; Recruiting
Howard I. Schwartz, Site 037

Borland-Groover Clinic, Jacksonville, Florida 32256, United States; Recruiting
Mark R. Fleisher, Site 126, Phone: 904-680-0871

University Of Florida, Gainesville, Florida 32610, United States; Recruiting
John F. Valentine, Site 156

Shafran Gasteroenterology Center, Winter Park, Florida 32789, United States; Recruiting
Ira Shafran, Site 185, Phone: 407-629-8121

Local Institution, Parktown West, Gauteng 2193, South Africa; Recruiting
Site 097

Local Institution, Pretoria, Gauteng 0048, South Africa; Recruiting
Site 101

Atlanta Gastroenterology Associates, Atlanta, Georgia 30342, United States; Recruiting
Douglas C. Wolf, Site 116, Phone: 404-257-9000

Local Institution, Goiania, Goias 74535, Brazil; Recruiting
Site 221

Local Institution, London, Greater London WC1E 6DB, United Kingdom; Recruiting
Site 112

Local Institution, London, Greater London E1 1BB, United Kingdom; Recruiting
Site 152

Rush University Medical Center, Chicago, Illinois 60612, United States; Active, not recruiting

University Of Chicago Hospitals, Chicago, Illinois 60637, United States; Recruiting
Stephen B. Hanauer, Site 163

Local Institution, Guadalajara, Jalisco 44160, Mexico; Recruiting
Site 022

Local Institution, Guadalajara, Jalisco 45050, Mexico; Recruiting
Site 023

Local Institution, Guadalajara, Jalisco 45200, Mexico; Recruiting
Site 024

Local Institution, Guadalajara, Jalisco 44200, Mexico; Recruiting
Site 131

Local Institution, Guadalajara, Jalisco 44340, Mexico; Recruiting
Site 226

Health Science Center, Pratt, Kansas 67124, United States; Recruiting
Daniel Suiter, Site 124, Phone: 620-672-7411

University Of Louisville, Louisville, Kentucky 40202, United States; Recruiting
Gerald W. Dryden, Jr., Site 128

University Of Kentucky Chandler Medical Center, Lexington, Kentucky 40536, United States; Recruiting
Willem J.S. De Villiers, Site 167

Local Institution, Kochi, Kerala 682304, India; Recruiting
Site 047

Local Institution, Overport, Kwa Zulu Natal 4091, South Africa; Recruiting
Site 100

Gulf Coast Research, Lafayette, Louisiana 70503, United States; Completed

Local Institution, Mumbai, Maharashtra 400020, India; Not yet recruiting
Site 069

Clinical Pharmacology Study Group, Worcester, Massachusetts 01610, United States; Recruiting
Charles Birbara, Site 030, Phone: 508-755-0201

Mayo Clinic Rochester, Rochester, Minnesota 55905, United States; Recruiting
William Sandborn, Site 034, Phone: 507-284-0959

Minnesota Gastroenterology, P.A., Plymouth, Minnesota 55446, United States; Recruiting
David I. Weinberg, Site 198

Kansas City Gastroenterology And Hepatology, Kansas City, Missouri 64131, United States; Recruiting
Bradley Freilich, Site 043, Phone: 816-361-0055

Center For Digestive & Liver Diseases, Inc., Mexico, Missouri 65265, United States; Recruiting
Glenn L. Gordon, Site 106, Phone: 573-581-7196

Aga Clinical Research Associates, Llc, Egg Harbor Twp, New Jersey 08234, United States; Recruiting
Barry Kaufman, Site 074, Phone: 609-407-1220

Local Institution, Camperdown, New South Wales 2050, Australia; Completed

Long Island Clinical Research, Great Neck, New York 11021, United States; Recruiting
Seymour Katz, Site 027, Phone: 516-466-1051

University Of Rochester Medical Center, Rochester, New York 14642, United States; Terminated

Good, Larry I., Rockville Centre, New York 11570, United States; Terminated

Mount Sinai School Of Medicine, New York, New York 10029, United States; Recruiting
Thomas Ullman, Site 091

Hudson Valley Medical Research Llc, Fishkill, New York 12524, United States; Recruiting
Qian Yun Xie, Site 140, Phone: 845-896-8709

Gastrointestinal Resrch Assoc., Setauket, New York 11733, United States; Recruiting
William Cohn, Site 227, Phone: 631-706-7070

Charlotte Gastroenterology & Hepatology, Pllc, Charlotte, North Carolina 28207, United States; Recruiting
John Hanson, Site 073, Phone: 704-375-9485

University Of North Carolina, Chapel Hill, North Carolina 27599, United States; Recruiting
Hans Herfarth, Site 080

Hanover Medical Specialists, P.A., Wilmington, North Carolina 28401, United States; Recruiting
William Andrew Gramley, Site 169

Piedmont Medical Research Associates, Winston Salem, North Carolina 27103, United States; Recruiting
Robert John Holmes, Site 191, Phone: 336-768-8062

Local Institution, Monterrey, Nuevo Leon 64460, Mexico; Recruiting
Site 020

Consultants For Clinical Research, Inc., Cincinnati, Ohio 45219, United States; Recruiting
Alan V. Safdi, Site 071, Phone: 513-872-4549

Gastrointestinal & Liver Diseases Consultants, Dayton, Ohio 45415, United States; Recruiting
Donald Lutter, Site 115, Phone: 937-427-1680

Gastroenterology Specialists, Inc., Canton, Ohio 44718, United States; Completed

Options Health Research, Llc, Tulsa, Oklahoma 74104, United States; Recruiting
Harvey Arthur Tatum, Site 028, Phone: 918-497-8437

Oklahoma Foundation For Digestive Research, Oklahoma City, Oklahoma 73104, United States; Recruiting
Philip B. Miner, Site 049, Phone: 405-271-4602

Healthcare Research Consultants, Tulsa, Oklahoma 74135, United States; Recruiting
David W. Morris, Site 218, Phone: 918-743-4002

Local Institution, London, Ontario N6A 5A5, Canada; Recruiting
Site 062

Local Institution, Toronto, Ontario M5G 1X5, Canada; Recruiting
Site 078

Local Institution, Toronto, Ontario M3N 2V7, Canada; Recruiting
Site 103

Local Institution, Kingston, Ontario K7L 5G2, Canada; Recruiting
Site 215

Local Institution, Ottawa, Ontario K1H 8L6, Canada; Recruiting
Site 223

Local Institution, Oxford, Oxfordshire OX 39DU, United Kingdom; Recruiting
Site 214

Local Institution, Curitiba, Parana 80060, Brazil; Recruiting
Site 173

Allegheny Center For Digestive Health, Pittsburgh, Pennsylvania 15212, United States; Completed

Hospital Of The University Of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Gary R. Lichtenstein, Site 188

Local Institution, Montreal, Quebec H1T 2M4, Canada; Recruiting
Site 008

Local Institution, Levis, Quebec G6V 3Z1, Canada; Recruiting
Site 200

Local Institution, South Brisbane, Queensland 4101, Australia; Completed

Local Institution, Herston, Queensland 4029, Australia; Active, not recruiting

Local Institution, Porto Alegre, Rio Grande Do Sul 90610, Brazil; Recruiting
Site 174

Local Institution, Porto Alegre, Rio Grande Do Sul 90035, Brazil; Recruiting
Site 177

Local Institution, Santo Andre - Sp, Sao Paulo 09060, Brazil; Recruiting
Site 176

Local Institution, Santos, Sao Paulo 11075, Brazil; Recruiting
Site 222

Local Institution, Campinas, Sao Paulo 13070, Brazil; Recruiting
Site 224

Local Institution, Culiacan, Sinaloa 80230, Mexico; Recruiting
Site 136

Local Institution, Hermosillo, Sonora 83280, Mexico; Recruiting
Site 134

Local Institution, Bedford Park, South Australia 5042, Australia; Completed

Medical University Of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Brenda Hoffman, Site 035

Local Institution, Launceston, Tasmania 7250, Australia; Completed

Gastroenterology Center Of The Midsouth, P.C., Germantown, Tennessee 38138, United States; Recruiting
Ziad Younes, Site 031, Phone: 901-820-0090

Memphis Gastroenterology Group, Germantown, Tennessee 38138, United States; Completed

Nashville Medical Research, Nashville, Tennessee 37205, United States; Completed

Alamo Medical Research, San Antonio, Texas 78215, United States; Completed

Austin Gastroenterology, Pa, Austin, Texas 78705, United States; Recruiting
Harish Gagneja, Site 093

Gastroenterology Clinic Of San Antonio, San Antonio, Texas 78229, United States; Recruiting
Charles W. Randall, Site 154, Phone: 210-615-3848

Local Institution, Fitzroy, Victoria 3065 VIC, Australia; Completed

Local Institution, Box Hill, Victoria 3128, Australia; Completed

Local Institution, South Ballarat, Victoria 3350, Australia; Active, not recruiting

Virginia Mason Medical Center, Seattle, Washington 98101, United States; Recruiting
Richard Kozarek, Site 070

Tacoma Digestive Disease Research Ctr., Tacoma, Washington 98405, United States; Completed

Local Institution, Fremantle, Western Australia 6160, Australia; Completed

Local Institution, Belville, Western Cape 7350, South Africa; Recruiting
Site 098

Local Institution, Panorama, Western Cape 7506, South Africa; Recruiting
Site 099

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: December 2006
Ending date: November 2010
Last updated: October 7, 2009