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

• ClinicalTrials.gov Identifier: NCT00406653
• Recruitment Status: Terminated
• First Posted: December 4, 2006
• Results First Posted: August 31, 2010
• Last Update Posted: September 14, 2010
• Sponsor: Bristol-Myers Squibb
• Information provided by: Bristol-Myers Squibb

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Crohn's Disease	Drug: abatacept; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 451 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Crohn's Disease (CD) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy
• Study Start Date: December 2006
• Actual Primary Completion Date: November 2009
• Actual Study Completion Date: November 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 4 arms for induction period 2 arms for maintenance period	Drug: abatacept; 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; Other Names: Orencia; BMS-188667
Placebo Comparator: 2; 4 arms for induction period 2 arms for maintenance period	Drug: placebo; 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	Drug: abatacept; ~10 mg/kg, every 28 days. Open- Label Extension Period until the drug is marketed for Crohn's Disease (CD)or the CD development program for abatacept is discontinued; Other Names: Orencia; BMS-188667

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12). ]
   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.
2. Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months) [ Time Frame: Day MP-365 (12 months) of maintenance therapy ]
   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.
3. 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 [ Time Frame: Between Day OL-1 and Day OL-617 ]
   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.
4. OL; Number of Participants With Adverse Events (AEs) of Special Interest [ Time Frame: Between Day OL-1 and Day OL-617 ]
   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).

Secondary Outcome Measures :

1. IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome) [ Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy ]
   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.
2. 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 [ Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy ]
   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.
3. IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, Day IP-85 ]
   The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-Baseline - Baseline value.
4. IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs [ Time Frame: Day IP-1 through Day IP-85 ]
   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.
5. IP; Number of Participants With Adverse Events (AEs) of Special Interest [ Time Frame: Day IP-1 through Day IP-85 ]
   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).
6. IP; Number of Participants With Positive Antibody Response to Abatacept (ABA) [ Time Frame: For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85); For participants treated in OL directly after IP: Day IP-1 to Day OL-1; For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits) ]
   A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition identified specific anti-ABA reactivity. Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig) category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.
7. IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF) [ Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy ]
   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.
8. IP; Number of Participants in CDAI-Defined Clinical Remission at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-TNF [ Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy ]
   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.
9. IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship [ Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy ]
   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.
10. MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs [ Time Frame: Between Day IP-85 and Day MP-365 ]
    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.
11. MP; Number of Participants With Adverse Events (AEs) of Special Interest: [ Time Frame: Between Day IP-85 and Day MP-365 ]
    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).
12. MP; Number of Participants With Positive Antibody Response to Abatacept [ Time Frame: For participants not entering OL: All measurements after Day MP-1 (including follow-up visits); For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1) ]
    A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.
13. MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365. [ Time Frame: Day MP-365 ]
    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.
14. MP; Number of Participants in CDAI-defined Clinical Remission at Both Day MP-169 and Day MP-365 [ Time Frame: Day MP-169 ]
    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.
15. MP; Change From Baseline to Day MP-365 in Short Form-36 (SF-36) [ Time Frame: Baseline, Day MP-365 ]
    The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
16. MP; Change From Baseline to Day MP-365 in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, Day MP-365 ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-baseline - Baseline value.
17. MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among All Participants Who Received Baseline Corticosteroid Therapy [ Time Frame: Day MP-365 ]
    Participants who received corticosteroid therapy (e.g. prednisone or budesonide) were to maintain a stable dose until Day MP-1. On or after Day MP-1, a recommended tapering regimen of corticosteroid therapy was planned if the participant was in remission (i.e., CDAI score < 150), or if the participant's condition had satisfactorily improved according to investigators clinical assessment. Other CD therapy was to remain at a stable dose throughout the Maintenance Period, with the exception of decreases due to drug-related toxicities.
18. MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among Participants Who Received Baseline Corticosteroid Therapy and Who Achieved CDAI-Defined Clinical Remission [ Time Frame: Day MP-365 ]
    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 is based partly on entries from participant's Diary (7 days before evaluation) which is kept while on study. CDAI scores range from 0 to ~600. Clinical response=CDAI reduction ≥100 or absolute CDAI <150. Clinical remission=CDAI <150. Moderate to severe disease=CDAI ≥220 and ≤450.
19. MP; Number of Participants With CDAI-Defined Clinical Response Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF) [ Time Frame: Day MP-365 ]
    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.
20. MP; Number of Participants in CDAI-Defined Clinical Remission Among Participants With Inadequate Response and/or Intolerance to Anti-TNF [ Time Frame: Day MP-365 ]
    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.
21. OL; Number of Participants Who Were Not On Background Corticosteroid Therapy Among All Participants Who Received Baseline Corticosteroid Therapy [ Time Frame: Between Day OL-1 and Day OL-617 ]
    Background corticosteroid therapy included prednisone or budesonide.
22. OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169 [ Time Frame: Day OL-169 ]
    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.
23. OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365 [ Time Frame: Day OL-365 ]
    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.
24. OL; Number of Participants With Positive Antibody Response to Abatacept [ Time Frame: For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose) ]
    A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.
25. OL; Number of Participants With Pharmacogenomic Marker Activity [ Time Frame: Between Day OL-1 and Day OL-617 ]
    Changes in the expression of individual ribonucleic acid (RNA) transcripts were to be evaluated from whole blood using both microarray transcriptional profiling and quantitative polymerase chain reaction (PCR) methods. Peripheral RNA transcriptional profiling was to be used only to identify individual RNA transcripts that differ in expression with respect to time, treatment and outcome.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 18 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

Contacts and Locations

Locations

United States, Alabama

University Of Alabama Medical Center

Birmingham, Alabama, United States, 35294

United States, California

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

The Permanente Medical Group, Inc

Sacramento, California, United States, 95825

United States, Florida

University Of Florida

Gainesville, Florida, United States, 32610

Borland-Groover Clinic

Jacksonville, Florida, United States, 32256

Shafran Gasteroenterology Center

Winter Park, Florida, United States, 32789

United States, Georgia

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States, 30342

United States, Illinois

University Of Chicago Hospitals

Chicago, Illinois, United States, 60637

United States, Kansas

Health Science Center

Pratt, Kansas, United States, 67124

United States, Kentucky

University Of Kentucky Medical Center

Lexington, Kentucky, United States, 40536

University Of Louisville

Louisville, Kentucky, United States, 40202

United States, Louisiana

Gulf Coast Research Assoc

Baton Rouge, Louisiana, United States, 70808

Vanderlick, Michael

Lafayette, Louisiana, United States, 70506

United States, Maryland

Maryland Digestive Disease Research

Laurel, Maryland, United States, 20707

United States, Minnesota

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, United States, 55446

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

United States, Missouri

Kansas City Gastroenterology And Hepatology

Kansas City, Missouri, United States, 64131

United States, New Jersey

Aga Clinical Research Associates, Llc

Egg Harbor Twp, New Jersey, United States, 08234

United States, New York

Long Island Clinical Research

Great Neck, New York, United States, 11021

Mount Sinai School Of Medicine

New York, New York, United States, 10029

U Of Rochester Gastroenterology And Hepatology

Rochester, New York, United States, 14642

University Endoscopy Center

Syracuse, New York, United States, 13210

United States, North Carolina

University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Charlotte Gastroenterology & Hepatology, Pllc

Charlotte, North Carolina, United States, 28207

Piedmont Medical Research Associates

Winston Salem, North Carolina, United States, 27103

United States, Ohio

Gastroenterology Specialists, Inc.

Canton, Ohio, United States, 44718

Consultants For Clinical Research

Cincinnati, Ohio, United States, 45219

Gastrointestinal & Liver Diseases Consultants

Dayton, Ohio, United States, 45415

United States, Oklahoma

Options Health Research, Llc

Tulsa, Oklahoma, United States, 74104

United States, Pennsylvania

Allegheny Center For Digestive Health

Pittsburgh, Pennsylvania, United States, 15212

United States, Tennessee

Southeastern Clinical Research

Chattanooga, Tennessee, United States, 37403

Gastroenterology Center Of The Midsouth, P.C.

Germantown, Tennessee, United States, 38138

Memphis Gastroenterology Group

Germantown, Tennessee, United States, 38138

Nashville Medical Research

Nashville, Tennessee, United States, 37205

United States, Texas

Austin Gastroenterology, Pa

Austin, Texas, United States, 78705

Gastroenterology Clinic Of San Antonio

San Antonio, Texas, United States, 78229

United States, Washington

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Australia, Australian Capital Territory

Local Institution

Garran, Australian Capital Territory, Australia, 2605

Australia, New South Wales

Local Institution

Camperdown, New South Wales, Australia, 2050

Australia, Queensland

Local Institution

Herston, Queensland, Australia, 4029

Local Institution

South Brisbane, Queensland, Australia, 4101

Australia, South Australia

Local Institution

Bedford Park, South Australia, Australia, 5042

Australia, Tasmania

Local Institution

Launceston, Tasmania, Australia, 7250

Australia, Victoria

Local Institution

Box Hill, Victoria, Australia, 3128

Local Institution

Fitzroy, Victoria, Australia, 3065 VIC

Local Institution

South Ballarat, Victoria, Australia, 3350

Australia, Western Australia

Local Institution

Fremantle, Western Australia, Australia, 6160

Belgium

Local Institution

Bonheiden, Belgium, 2820

Local Institution

Leuven, Belgium, 3000

Local Institution

Roeselare, Belgium, 8800

Brazil

Local Institution

Salvador, Bahia, Brazil, 42700

Local Institution

Goiania, Goias, Brazil, 74535

Local Institution

Curitiba, Parana, Brazil, 80060

Local Institution

Porto Alegre, Rio Grande Do Sul, Brazil, 90035

Local Institution

Sao Paulo, Brazil, 01246

Canada, Alberta

Local Institution

Calgary, Alberta, Canada, T2N 4N1

Local Institution

Edmonton, Alberta, Canada, T6G 2X8

Canada, British Columbia

Local Institution

Vancouver, British Columbia, Canada, V6Z 2K5

Canada, Newfoundland and Labrador

Local Institution

St Johns, Newfoundland and Labrador, Canada, A1B 3V6

Canada, Nova Scotia

Local Institution

Halifax, Nova Scotia, Canada, B3H 2Y9

Canada, Ontario

Local Institution

London, Ontario, Canada, N6A 5A5

Local Institution

Ottawa, Ontario, Canada, K1H 8L6

Local Institution

Toronto, Ontario, Canada, M3N 2V7

Canada, Quebec

Local Institution

Montreal, Quebec, Canada, H1T 2M4

Czech Republic

Local Institution

Ceske Budejovice, Czech Republic, 370 87

Denmark

Local Institution

Aalborg, Denmark, 9100

Local Institution

Arhus C, Denmark, 8000

Local Institution

Hvidovre, Denmark, 2650

Local Institution

Odense C, Denmark, 5000

France

Local Institution

Amiens Cedex 1, France, 80054

Local Institution

Lille Cedex, France, 59037

Local Institution

Nice, France, 06200

Local Institution

Paris Cedex 10, France, 75475

Local Institution

Pessac, France, 33064

Local Institution

Toulouse Cedex, France, 31059

Germany

Local Institution

Kiel, Germany, 24105

Local Institution

Muenster, Germany, 48129

Local Institution

Muenster, Germany, 48159

India

Local Institution

Hyderabad, Andhra Pradesh, India, 500082

Local Institution

Hyderabad, India, 500058

Local Institution

Mangalore, India, 575001

Local Institution

Manipal, India, 576104

Local Institution

Mumbai, India, 400 029

Local Institution

Mysore, India, 570004

Italy

Local Institution

Napoli, Italy, 80138

Local Institution

Padova, Italy, 35128

Local Institution

Roma, Italy, 00152

Local Institution

San Giovanni Rotondo, Italy, 71013

Mexico

Local Institution

Torreon, Coahuila, Mexico, 27250

Local Institution

Mexico, D.F., Distrito Federal, Mexico, 14000

Local Institution

Monterrey, Nuevo Leon, Mexico, 64460

Netherlands

Local Institution

Amsterdam, Netherlands, 1105 AZ

Local Institution

Groningen, Netherlands, 9713 GZ

Local Institution

Rotterdam, Netherlands, 3015 CE

Poland

Local Institution

Katowice, Poland, 40-752

Puerto Rico

Local Institution

Ponce, Puerto Rico, 00716

South Africa

Local Institution

Overport, Kwa Zulu Natal, South Africa, 4091

Local Institution

Belville, Western Cape, South Africa, 7535

Switzerland

Local Institution

Bern, Switzerland, 3010

Local Institution

Lausanne, Switzerland, 1011

Local Institution

Zuerich, Switzerland, 8091

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Study Director, Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT00406653
• Other Study ID Numbers: IM101-084
• First Posted: December 4, 2006
• Results First Posted: August 31, 2010
• Last Update Posted: September 14, 2010
• Last Verified: September 2010

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Abatacept; Immune Checkpoint Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents