A Study of Abatacept in Patients With Active Crohn's Disease

NCT00406653 | Terminated Phase 3 Results DMC

• 1 other identifier: IM101-084
• Study Type: interventional
• Target: 451
• Locations: 17 countries
• Sites: 101

Brief Summary

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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (4)

• Induction Period (IP); Number of Participants With Crohn's Disease Activity Index (CDAI)-Defined Clinical Response at Both Day IP-57 and Day IP-85

  CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.

  At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).

• Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months)

  CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<150 points. Clinical remission=CDAI \<150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.

  Day MP-365 (12 months) of maintenance therapy

• Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs

  AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.

  Between Day OL-1 and Day OL-617

• OL; Number of Participants With Adverse Events (AEs) of Special Interest

  AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).

  Between Day OL-1 and Day OL-617

Secondary Outcomes (25)

• IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome)

  At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy

• IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship

  At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy

• IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ)

  Baseline, Day IP-85

• IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs

  Day IP-1 through Day IP-85

• IP; Number of Participants With Adverse Events (AEs) of Special Interest

  Day IP-1 through Day IP-85

Study Arms (3)

1

EXPERIMENTAL

4 arms for induction period 2 arms for maintenance period

Drug: abatacept

2

PLACEBO COMPARATOR

4 arms for induction period 2 arms for maintenance period

Drug: placebo

abatacept

OTHER

1 arm for open-label extension phase

Drug: abatacept

Interventions

abatacept DRUG

Dextrose 5% in water, intravenous (IV). Placebo on days Induction Period (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. Induction Period 3 months Maintenance Period 12 months

Also known as: Orencia, BMS-188667

1

placebo DRUG

Normal saline, IV, 0 mg/kg, every 28 days. Induction Period 3 months Maintenance Period 12 months

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• have had Crohn's Disease for at least 3 months
• moderate to severely active Crohn's Disease
• have had an inadequate response or intolerance to other Crohn's Disease treatments

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (101)

University Of Alabama Medical Center

Birmingham, Alabama, 35294, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

The Permanente Medical Group, Inc

Sacramento, California, 95825, United States

Location

University Of Florida

Gainesville, Florida, 32610, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

Shafran Gasteroenterology Center

Winter Park, Florida, 32789, United States

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Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

University Of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Health Science Center

Pratt, Kansas, 67124, United States

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University Of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

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University Of Louisville

Louisville, Kentucky, 40202, United States

Location

Gulf Coast Research Assoc

Baton Rouge, Louisiana, 70808, United States

Location

Vanderlick, Michael

Lafayette, Louisiana, 70506, United States

Location

Maryland Digestive Disease Research

Laurel, Maryland, 20707, United States

Location

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, 55446, United States

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Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Kansas City Gastroenterology And Hepatology

Kansas City, Missouri, 64131, United States

Location

Aga Clinical Research Associates, Llc

Egg Harbor Twp, New Jersey, 08234, United States

Location

Long Island Clinical Research

Great Neck, New York, 11021, United States

Location

Mount Sinai School Of Medicine

New York, New York, 10029, United States

Location

U Of Rochester Gastroenterology And Hepatology

Rochester, New York, 14642, United States

Location

University Endoscopy Center

Syracuse, New York, 13210, United States

Location

University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Charlotte Gastroenterology & Hepatology, Pllc

Charlotte, North Carolina, 28207, United States

Location

Piedmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

Gastroenterology Specialists, Inc.

Canton, Ohio, 44718, United States

Location

Consultants For Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Gastrointestinal & Liver Diseases Consultants

Dayton, Ohio, 45415, United States

Location

Options Health Research, Llc

Tulsa, Oklahoma, 74104, United States

Location

Allegheny Center For Digestive Health

Pittsburgh, Pennsylvania, 15212, United States

Location

Southeastern Clinical Research

Chattanooga, Tennessee, 37403, United States

Location

Gastroenterology Center Of The Midsouth, P.C.

Germantown, Tennessee, 38138, United States

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Memphis Gastroenterology Group

Germantown, Tennessee, 38138, United States

Location

Nashville Medical Research

Nashville, Tennessee, 37205, United States

Location

Austin Gastroenterology, Pa

Austin, Texas, 78705, United States

Location

Gastroenterology Clinic Of San Antonio

San Antonio, Texas, 78229, United States

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Virginia Mason Medical Center

Seattle, Washington, 98101, United States

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Local Institution

Garran, Australian Capital Territory, 2605, Australia

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Camperdown, New South Wales, 2050, Australia

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Herston, Queensland, 4029, Australia

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South Brisbane, Queensland, 4101, Australia

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Bedford Park, South Australia, 5042, Australia

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Launceston, Tasmania, 7250, Australia

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Box Hill, Victoria, 3128, Australia

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Fitzroy, Victoria, 3065 VIC, Australia

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South Ballarat, Victoria, 3350, Australia

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Fremantle, Western Australia, 6160, Australia

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Bonheiden, 2820, Belgium

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Leuven, 3000, Belgium

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Roeselare, 8800, Belgium

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Salvador, Estado de Bahia, 42700, Brazil

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Goiânia, Goiás, 74535, Brazil

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Curitiba, Paraná, 80060, Brazil

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Porto Alegre, Rio Grande do Sul, 90035, Brazil

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São Paulo, São Paulo, 01246, Brazil

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Calgary, Alberta, T2N 4N1, Canada

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Edmonton, Alberta, T6G 2X8, Canada

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Vancouver, British Columbia, V6Z 2K5, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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London, Ontario, N6A 5A5, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M3N 2V7, Canada

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Montreal, Quebec, H1T 2M4, Canada

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České Budějovice, 370 87, Czechia

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Aalborg, 9100, Denmark

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Arhus C, 8000, Denmark

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Hvidovre, 2650, Denmark

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Odense C, 5000, Denmark

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Amiens, 80054, France

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Lille, 59037, France

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Nice, 06200, France

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Paris, 75475, France

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Pessac, 33064, France

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Toulouse, 31059, France

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Kiel, 24105, Germany

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Münster, 48129, Germany

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Münster, 48159, Germany

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Hyderabad, Andhra Pradesh, 500082, India

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Hyderabad, 500058, India

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Mangalore, 575001, India

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Manipal, 576104, India

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Mumbai, 400 029, India

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Mysore, 570004, India

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Napoli, 80138, Italy

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Padua, 35128, Italy

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Roma, 00152, Italy

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San Giovanni Rotondo, 71013, Italy

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Torreón, Coahuila, 27250, Mexico

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Mexico City, Mexico City, 14000, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Amsterdam, 1105 AZ, Netherlands

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Groningen, 9713 GZ, Netherlands

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Rotterdam, 3015 CE, Netherlands

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Katowice, 40-752, Poland

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Ponce, 00716, Puerto Rico

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Overport, KwaZulu-Natal, 4091, South Africa

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Belville, Western Cape, 7535, South Africa

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Bern, 3010, Switzerland

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Lausanne, 1011, Switzerland

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Zurich, 8091, Switzerland

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Related Publications (1)

• 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.

  PMID: 22504093 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 4, 2006
• Study Start: December 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 14, 2010
• Results First Posted: August 31, 2010

Record last verified: 2010-09

Locations

IT (4); ME (3); BR (5); NL (3); ZA (2); CA (9); DK (4); AU (10); PL (1); US (37); BE (3); PR (1); CZ (1); DE (3); FR (6); IN (6); CH (3)