A Study of Abatacept in Patients With Active Ulcerative Colitis

NCT ID: NCT00410410

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 591 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-11-30

Brief Summary

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

Detailed Description

The Induction Period First Cohort (IP1C) arms (30/10 mg/kg and 10 mg/kg) were placebo-controlled arms that were used for the primary endpoint and its analysis. The Induction Period Second Cohort arms (IP2C 30/10 mg/kg and 10 mg/kg) were not placebo-controlled, their sole purpose being to provide sufficient numbers of participants for the maintenance phase. The first cohort (IP1C) was randomized to receive placebo or 1 of 3 doses of abatacept. Following completion of the IP1C randomization, a second cohort (IP2C) was randomized to receive 1 of 2 doses of abatacept. After all participants in the IP1C completed or discontinued, the data was locked and the formal analysis for the Induction Period primary endpoint was performed. Summary tables for the second cohort (IP2C) and the Maintenance and Open-label phases were generated from a second, subsequent data lock.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Abatacept (ABA)

Induction Period; 3 arms for Cohort 1: ABA 30/~10 mg/kg (ABA administered at 30 mg/kg followed by ABA at ~10 mg/kg), ABA ~10 mg/kg, ABA 3 mg/kg

Induction Period; 2 arms for Cohort 2: ABA 30/~10 mg/kg and Second Cohort ABA ~10 mg/kg

1 arm for maintenance period (ABA ~10 mg/kg)

Group Type: EXPERIMENTAL

abatacept (ABA)

Intervention Type: DRUG

Dextrose 5% in water, IV. Placebo on days IP-1, IP-15,IP-29, IP-57; 3 mg/kg on days IP-1, IP-15,IP-29, IP-57; 10 mg/kg on days IP-1, IP-15,IP-29, IP-57; or 30 mg/kg on days IP-1,IP-15 and ~10 mg/kg on days IP-29, IP-57 (ABA 30/~10 mg/kg Group).

Induction Period 3 months

Maintenance Period 12 months

Placebo

1 arm for induction period

1 arm for maintenance period

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Normal saline, IV, 0 mg/kg, every 28 days.

Induction Period 3 months

Maintenance Period 12 months

abatacept

1 arm for open-label extension phase (ABA \~10 mg/kg)

Group Type: OTHER

abatacept

Intervention Type: DRUG

~10 mg/kg, once monthly

Open- Label Extension Period until the drug is marketed for UC or the UC development program for abatacept is discontinued

Interventions

abatacept (ABA)

Dextrose 5% in water, IV. Placebo on days IP-1, IP-15,IP-29, IP-57; 3 mg/kg on days IP-1, IP-15,IP-29, IP-57; 10 mg/kg on days IP-1, IP-15,IP-29, IP-57; or 30 mg/kg on days IP-1,IP-15 and ~10 mg/kg on days IP-29, IP-57 (ABA 30/~10 mg/kg Group).

Induction Period 3 months

Maintenance Period 12 months

Intervention Type: DRUG

placebo

Normal saline, IV, 0 mg/kg, every 28 days.

Induction Period 3 months

Maintenance Period 12 months

Intervention Type: DRUG

abatacept

~10 mg/kg, once monthly

Open- Label Extension Period until the drug is marketed for UC or the UC development program for abatacept is discontinued

Intervention Type: DRUG

Other Intervention Names

Orencia; BMS-188667; Orencia; BMS-188667

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

University Of Alabama At Birmingham

Birmingham, Alabama, United States

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

The Permanente Medical Group, Inc

Sacramento, California, United States

Western States Clinical Research Inc.

Wheat Ridge, Colorado, United States

Litchfield County Gastroenterology Assoc.

Torrington, Connecticut, United States

University Of Florida

Gainesville, Florida, United States

Borland-Groover Clinic

Jacksonville, Florida, United States

Miami Research Associates

Miami, Florida, United States

Shafran Gasteroenterology Center

Winter Park, Florida, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University Of Chicago Hospitals

Chicago, Illinois, United States

Health Science Center

Pratt, Kansas, United States

University Of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

University Of Louisville

Louisville, Kentucky, United States

Gulf Coast Research

Lafayette, Louisiana, United States

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Kansas City Gastroenterology And Hepatology

Kansas City, Missouri, United States

Center For Digestive & Liver Diseases, Inc.

Mexico, Missouri, United States

Aga Clinical Research Associates, Llc

Egg Harbor Twp, New Jersey, United States

Hudson Valley Medical Research Llc

Fishkill, New York, United States

Long Island Clinical Research

Great Neck, New York, United States

Mount Sinai School Of Medicine

New York, New York, United States

University Of Rochester Medical Center

Rochester, New York, United States

Good, Larry I.

Rockville Centre, New York, United States

Gastrointestinal Resrch Assoc.

Setauket, New York, United States

University Of North Carolina

Chapel Hill, North Carolina, United States

Charlotte Gastroenterology & Hepatology, Pllc

Charlotte, North Carolina, United States

Hanover Medical Specialists, P.A.

Wilmington, North Carolina, United States

Piedmont Medical Research Associates

Winston-Salem, North Carolina, United States

Gastroenterology Specialists, Inc.

Canton, Ohio, United States

Consultants For Clinical Research, Inc.

Cincinnati, Ohio, United States

Gastrointestinal & Liver Diseases Consultants

Dayton, Ohio, United States

Oklahoma Foundation For Digestive Research

Oklahoma City, Oklahoma, United States

Options Health Research, Llc

Tulsa, Oklahoma, United States

Healthcare Research Consultants

Tulsa, Oklahoma, United States

Hospital Of The University Of Pennsylvania

Philadelphia, Pennsylvania, United States

Allegheny Center For Digestive Health

Pittsburgh, Pennsylvania, United States

Medical University Of South Carolina

Charleston, South Carolina, United States

Gastroenterology Center Of The Midsouth, P.C.

Germantown, Tennessee, United States

Memphis Gastroenterology Group

Germantown, Tennessee, United States

Nashville Medical Research

Nashville, Tennessee, United States

Austin Gastroenterology, Pa

Austin, Texas, United States

Alamo Medical Research

San Antonio, Texas, United States

Gastroenterology Clinic Of San Antonio

San Antonio, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Tacoma Digestive Disease Research Ctr.

Tacoma, Washington, United States

Local Institution

Garran, Australian Capital Territory, Australia

Local Institution

Camperdown, New South Wales, Australia

Local Institution

Herston, Queensland, Australia

Local Institution

South Brisbane, Queensland, Australia

Local Institution

Bedford Park, South Australia, Australia

Local Institution

Launceston, Tasmania, Australia

Local Institution

Box Hill, Victoria, Australia

Local Institution

Fitzroy, Victoria, Australia

Local Institution

South Ballarat, Victoria, Australia

Local Institution

Fremantle, Western Australia, Australia

Local Institution

Brussels, , Belgium

Local Institution

Leuven, , Belgium

Local Institution

Salvador, Estado de Bahia, Brazil

Local Institution

Goiânia, Goiás, Brazil

Local Institution

Curitiba, Paraná, Brazil

Local Institution

Rio de Janeiro, Rio de Janeiro, Brazil

Local Institution

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution

Campinas, São Paulo, Brazil

Local Institution

Santo Andre - Sp, São Paulo, Brazil

Local Institution

Santos, São Paulo, Brazil

Local Institution

São Paulo, São Paulo, Brazil

Local Institution

Vancouver, British Columbia, Canada

Local Institution

Vancouver, British Columbia, Canada

Local Institution

Kingston, Ontario, Canada

Local Institution

London, Ontario, Canada

Local Institution

Ottawa, Ontario, Canada

Local Institution

Toronto, Ontario, Canada

Local Institution

Toronto, Ontario, Canada

Local Institution

Lévis, Quebec, Canada

Local Institution

Montreal, Quebec, Canada

Local Institution

Québec, Quebec, Canada

Local Institution

Brno - Bohunice, , Czechia

Local Institution

České Budějovice, , Czechia

Local Institution

Amiens, , France

Local Institution

Clichy, , France

Local Institution

Lille, , France

Local Institution

Nice, , France

Local Institution

Paris, , France

Local Institution

Pessac, , France

Local Institution

Toulouse, , France

Local Institution

Kiel, , Germany

Local Institution

Münster, , Germany

Local Institution

Münster, , Germany

Local Institution

Hyderabad, Andhra Pradesh, India

Local Institution

Kochi, Kerala, India

Local Institution

Mumbai, Maharashtra, India

Local Institution

Bangalore, , India

Local Institution

Bangalore, , India

Local Institution

Delhi, , India

Local Institution

Hyderabad, , India

Local Institution

Mangalore, , India

Local Institution

Manipal, , India

Local Institution

Mumbai, , India

Local Institution

Mumbai, , India

Local Institution

Mysore, , India

Local Institution

Dublin, Dublin, Ireland

Local Institution

Napoli, , Italy

Local Institution

Padua, , Italy

Local Institution

Roma, , Italy

Local Institution

Roma, , Italy

Local Institution

San Giovanni Rotondo, , Italy

Local Institution

Chihuahua City, Chihuahua, Mexico

Local Institution

Torreón, Coahuila, Mexico

Local Institution

Guadalajara, Jalisco, Mexico

Local Institution

Guadalajara, Jalisco, Mexico

Local Institution

Guadalajara, Jalisco, Mexico

Local Institution

Guadalajara, Jalisco, Mexico

Local Institution

Guadalajara, Jalisco, Mexico

Local Institution

Df, Mexico City, Mexico

Local Institution

Mexico City, Mexico City, Mexico

Local Institution

Mexico, D. F., Mexico City, Mexico

Local Institution

Monterrey, Nuevo León, Mexico

Local Institution

Culiacán, Sinaloa, Mexico

Local Institution

Hermosillo, Sonora, Mexico

Local Institution

Amersfoort, , Netherlands

Local Institution

Amsterdam, , Netherlands

Local Institution

Groningen, , Netherlands

Local Institution

Katowice, , Poland

Local Institution

Warsaw, , Poland

Local Institution

Wroclaw, , Poland

Local Institution

Ponce, , Puerto Rico

Local Institution

Parktown West, Gauteng, South Africa

Local Institution

Pretoria, Gauteng, South Africa

Local Institution

Overport, KwaZulu-Natal, South Africa

Local Institution

Belville, Western Cape, South Africa

Local Institution

Panorama, Western Cape, South Africa

Local Institution

Seoul, , South Korea

Local Institution

Bern, , Switzerland

Local Institution

Zurich, , Switzerland

Local Institution

London, Greater London, United Kingdom

Local Institution

London, Greater London, United Kingdom

Local Institution

Oxford, Oxfordshire, United Kingdom

Countries

United States; Australia; Belgium; Brazil; Canada; Czechia; France; Germany; India; Ireland; Italy; Mexico; Netherlands; Poland; Puerto Rico; South Africa; South Korea; Switzerland; United Kingdom

References

Sandborn WJ, Colombel JF, Sands BE, Rutgeerts P, Targan SR, Panaccione R, Bressler B, Geboes K, Schreiber S, Aranda R, Gujrathi S, Luo A, Peng Y, Salter-Cid L, Hanauer SB. Abatacept for Crohn's disease and ulcerative colitis. Gastroenterology. 2012 Jul;143(1):62-69.e4. doi: 10.1053/j.gastro.2012.04.010. Epub 2012 Apr 12.

Reference Type: DERIVED

PMID: 22504093 (View on PubMed)

Other Identifiers

IM101-108

Identifier Type: -

Identifier Source: org_study_id