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

This study has been terminated.
(Sponsor Decision)
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00406653
First received: December 1, 2006
Last updated: September 10, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Crohn's Disease
Drug: abatacept
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • OL; Number of Participants With Adverse Events (AEs) of Special Interest [ Time Frame: Between Day OL-1 and Day OL-617 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, Day IP-85 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • IP; Number of Participants With Adverse Events (AEs) of Special Interest [ Time Frame: Day IP-1 through Day IP-85 ] [ Designated as safety issue: Yes ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • MP; Number of Participants With Adverse Events (AEs) of Special Interest: [ Time Frame: Between Day IP-85 and Day MP-365 ] [ Designated as safety issue: Yes ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    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.

  • MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365. [ Time Frame: Day MP-365 ] [ Designated as safety issue: No ]
    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.

  • MP; Number of Participants in CDAI-defined Clinical Remission at Both Day MP-169 and Day MP-365 [ Time Frame: Day MP-169 ] [ Designated as safety issue: No ]
    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.

  • MP; Change From Baseline to Day MP-365 in Short Form-36 (SF-36) [ Time Frame: Baseline, Day MP-365 ] [ Designated as safety issue: No ]
    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.

  • MP; Change From Baseline to Day MP-365 in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, Day MP-365 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Background corticosteroid therapy included prednisone or budesonide.

  • OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169 [ Time Frame: Day OL-169 ] [ Designated as safety issue: No ]
    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.

  • OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365 [ Time Frame: Day OL-365 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • OL; Number of Participants With Pharmacogenomic Marker Activity [ Time Frame: Between Day OL-1 and Day OL-617 ] [ Designated as safety issue: No ]
    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.


Enrollment: 451
Study Start Date: December 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406653

  Show 101 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00406653     History of Changes
Other Study ID Numbers: IM101-084
Study First Received: December 1, 2006
Results First Received: July 30, 2010
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014