Trial record 1 of 1 for:    ulcerative colitis abatacept
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A Study of Abatacept in Patients With Active Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00410410
First received: December 11, 2006
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Ulcerative Colitis
Drug: abatacept (ABA)
Drug: placebo
Drug: abatacept
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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 Ulcerative Colitis (UC) 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 Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) [ Time Frame: Week 12 (Day IP-85) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.

  • Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12 [ Time Frame: Month 12 (Day MP-365) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.

  • Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation [ Time Frame: Day OL-1 through the end of the OL ] [ 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 AEs of Special Interest [ Time Frame: Day OL-1 through Day OL-729 ] [ 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).

  • OL; Number of Participants With Physical Examination Findings [ Time Frame: Day OL-1 through Day OL-729 ] [ Designated as safety issue: Yes ]
    Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).

  • OL; Number of Participants With Marked Hematology Laboratory Abnormalities [ Time Frame: Day OL-1 through Day OL-729 ] [ Designated as safety issue: Yes ]
    High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.

  • OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities [ Time Frame: Day OL-1 through Day OL-729 ] [ Designated as safety issue: Yes ]
    Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN

  • OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities [ Time Frame: Day OL-1 through Day OL-729 ] [ Designated as safety issue: Yes ]
    Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3


Secondary Outcome Measures:
  • IP; Baseline Mayo Score: IP1C [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.

  • IP; Number of Participants in Clinical Remission (Per Mayo Score) at Week 12: IP1C [ Time Frame: Week 12 (Day IP-85) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.

  • IP; Number of Participants in Mucosal Healing (Per Mayo Score) at Week 12: IP1C [ Time Frame: Week 12 (Day IP-85) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point

  • IP; Number of Participants With Clinical Response (Per Mayo Score) at Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C [ Time Frame: Week 12 (Day IP-85) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.

  • IP; Baseline Inflammatory Bowel Disease Questionnaire (IBDQ) Score: IP1C [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response 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 can range between 32 to 224 with higher scores indicating a better quality of life.

  • IP; Mean Change From Baseline To Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ): IP1C [ Time Frame: Baseline (Day IP-1), Day IP-85 (Week 12) ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response 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 can range between 32 to 224 with higher scores indicating a better quality of life.

  • IP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C [ Time Frame: Day IP-85 (Week 12) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of ≤1 point was indicative of mild disease.

  • IP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C [ Time Frame: Day IP-85 (Week 12) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of ≤1 point was indicative of mild disease.

  • IP; Number of Participants With Mayo Physician Global Assessment (PGA) Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C [ Time Frame: Day IP-85 (Week 12) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of ≤1 point was indicative of mild disease.

  • IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With Clinical Response At Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C [ Time Frame: Week 12 (Day IP-85) ] [ Designated as safety issue: No ]
    The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.

  • IP; Number of Participants With Clinical Response At Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C [ Time Frame: Week 12 (Day IP-85) ] [ Designated as safety issue: No ]
    The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.

  • IP; Number of Participants in Clinical Remission at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C [ Time Frame: Week 12 (Day IP-85) ] [ Designated as safety issue: No ]

    The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance

    =inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.


  • IP; Number of Participants in Mucosal Healing at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C [ Time Frame: Week 12 (Day IP-85) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.

  • IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation: IP1C + IP2C [ 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 AEs Of Special Interest: IP1C + IP2C [ 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 Physical Examination Findings: IP1C + IP2C [ Time Frame: Day IP-1 through Day IP-85 ] [ Designated as safety issue: Yes ]
    Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).

  • IP; Number of Participants With Marked Hematology Laboratory Abnormalities: IP1C [ Time Frame: Day IP-1 through Day IP-85 ] [ Designated as safety issue: Yes ]
    High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.

  • IP; Number of Participants With Marked Liver and Kidney Function and Electrolyte Laboratory Abnormalities: IP1C [ Time Frame: Day IP-1 through Day IP-85 ] [ Designated as safety issue: Yes ]
    Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN

  • IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP1C [ Time Frame: Day IP-1 through Day IP-85 ] [ Designated as safety issue: Yes ]
    Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3

  • IP; Number of Participants With Marked Hematology, Liver and Kidney Function, and Electrolyte Laboratory Abnormalities: IP2C [ Time Frame: Day IP-1 through Day IP-85 ] [ Designated as safety issue: Yes ]
    High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN;

  • IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP2C [ Time Frame: Day IP-1 through Day IP-85 ] [ Designated as safety issue: Yes ]
    Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3

  • IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C [ 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 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 in Clinical Remission at Month 12 [ Time Frame: Month 12 (Day MP-365) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.

  • MP; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) at Month 12 [ Time Frame: Month 12 (Day MP-365) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point

  • MP; Number of Participants in Clinical Remission at Both Month 6 and Month 12 [ Time Frame: Month 6 (Day MP-169), Month 12 (Day MP-365) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.

  • MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids and Achieved Clinical Remission by Month 12 [ Time Frame: Day MP-365 (Month 12) ] [ Designated as safety issue: No ]
    Baseline corticosteroids equivalent of ≤30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.

  • MP; Mean Change From Baseline to Month 12 in IBDQ [ Time Frame: Day MP-365 ] [ Designated as safety issue: No ]
    The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response 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 can range between 32 to 224 with higher scores indicating a better quality of life.

  • MP; Mean Change From Baseline to Month 12 in Short Form-36 (SF-36) [ Time Frame: Day MP-365 ] [ Designated as safety issue: No ]
    The SF-36 is a validated instrument to measure health-related quality of life across multiple disease states. Individual subscale scores and 2 summary scores are calculated: (1) physical component summary (PCS) which includes physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS) which includes vitality, social functioning, role-emotional, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight, with values ranging from worse health (0) to best health (100).

  • MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids for 90 Consecutive Days and Achieved Clinical Remission by Month 12 [ Time Frame: Day MP-365 (Month 12) ] [ Designated as safety issue: No ]
    Baseline corticosteroids equivalent of ≤30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.

  • MP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Month 12 [ Time Frame: Day MP-365 (Month 12) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of ≤1 point was indicative of mild disease.

  • MP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Month 12 [ Time Frame: Day MP-365 (Month 12) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of ≤1 point was indicative of mild disease.

  • MP; Number of Participants With Mayo PGA Subscores Indicating Mild Disease (≤1 Point) at Month 12 [ Time Frame: Day MP-365 (Month 12) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of ≤1 point was indicative of mild disease.

  • MP; Number of Participants With Clinical Response at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) [ Time Frame: Month 12 (Day MP-365) ] [ Designated as safety issue: No ]
    The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.

  • MP; Number of Participants With Clinical Remission at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) [ Time Frame: Month 12 (Day MP-365) ] [ Designated as safety issue: No ]
    The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance =inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.

  • MP; Number of Participants With Clinical Mucosal Healing at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) [ Time Frame: Month 12 (Day MP-365) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.

  • MP; Number of Participants With Abatacept-Induced Antibodies [ Time Frame: For participants not entering OL: All measurements starting 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 Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation [ Time Frame: Day MP-1 through 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 AEs of Special Interest [ Time Frame: Day MP-1 through 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 Physical Examination Findings [ Time Frame: Day IP-85 through Day MP-365 ] [ Designated as safety issue: Yes ]
    Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).

  • MP; Number of Participants With Marked Hematology Laboratory Abnormalities [ Time Frame: Day IP-85 through Day MP-365 ] [ Designated as safety issue: Yes ]
    High=greater than ULN, Low=lower than LLN. LLN/ULN= HGB: >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; PLT: <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; GGT: >2 x ULN; Bilirubin: >2 x ULN; BUN: >2 x BL; Na: <0.95 x LLN/ >1.05 x ULN; K: <0.9 x LLN/ >1.1 x ULN; Ca: <0.8 x LLN/>1.2 x ULN

  • MP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities [ Time Frame: Day IP-85 through Day MP-365 ] [ Designated as safety issue: Yes ]
    Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3

  • OL; Number of Participants With Clinical Response Over Time [ Time Frame: Day OL-1 through Day OL-729 ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.

  • OL; Number of Participants With Clinical Remission Over Time [ Time Frame: Day OL-1 through Day OL-729 ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.

  • OL; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) During OL [ Time Frame: Open-Label Period (Day OL-1 through Day OL-729) ] [ Designated as safety issue: No ]
    The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point

  • OL; Number of Participants With Clinical Response or Clinical Remission Upon Retreatment With Abatacept Among Those Who Received Abatacept in the IP or MP Period [ Time Frame: Last Study Visit (Day OL-729) ] [ Designated as safety issue: No ]
    The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Clinical remission = Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Change from Baseline= post-Baseline - Baseline value.

  • OL; Number of Participants With Abatacept-Induced Antibodies [ 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 Using Corticosteroids During OL [ Time Frame: Day OL-1 through Day OL-729 ] [ Designated as safety issue: No ]
    Participants taking oral corticosteroids (equivalent of ≤ 30 mg prednisone daily) must have met minimum treatment duration at entry into IP and had stable dose for ≥2 weeks prior to entry into the IP.


Enrollment: 591
Study Start Date: December 2006
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)

Drug: 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

Other Names:
  • Orencia
  • BMS-188667
Placebo Comparator: Placebo

1 arm for induction period

1 arm 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 (ABA ~10 mg/kg)
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

Other Names:
  • Orencia
  • BMS-188667

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410410

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
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, Colorado
Western States Clinical Research Inc.
Wheatridge, Colorado, United States, 80033
United States, Connecticut
Litchfield County Gastroenterology Assoc.
Torrington, Connecticut, United States, 06790
United States, Florida
University Of Florida
Gainesville, Florida, United States, 32610
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
Miami Research Associates
Miami, Florida, United States, 33143
Shafran Gasteroenterology Center
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
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 Chandler Medical Center
Lexington, Kentucky, United States, 40536
University Of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Gulf Coast Research
Lafayette, Louisiana, United States, 70503
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
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
Center For Digestive & Liver Diseases, Inc.
Mexico, Missouri, United States, 65265
United States, New Jersey
Aga Clinical Research Associates, Llc
Egg Harbor Twp, New Jersey, United States, 08234
United States, New York
Hudson Valley Medical Research Llc
Fishkill, New York, United States, 12524
Long Island Clinical Research
Great Neck, New York, United States, 11021
Mount Sinai School Of Medicine
New York, New York, United States, 10029
University Of Rochester Medical Center
Rochester, New York, United States, 14642
Good, Larry I.
Rockville Centre, New York, United States, 11570
Gastrointestinal Resrch Assoc.
Setauket, New York, United States, 11733
United States, North Carolina
University Of North Carolina
Chapel Hill, North Carolina, United States, 27599
Charlotte Gastroenterology & Hepatology, Pllc
Charlotte, North Carolina, United States, 28207
Hanover Medical Specialists, P.A.
Wilmington, North Carolina, United States, 28401
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, Inc.
Cincinnati, Ohio, United States, 45219
Gastrointestinal & Liver Diseases Consultants
Dayton, Ohio, United States, 45415
United States, Oklahoma
Oklahoma Foundation For Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Options Health Research, Llc
Tulsa, Oklahoma, United States, 74104
Healthcare Research Consultants
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny Center For Digestive Health
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Medical University Of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
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
Alamo Medical Research
San Antonio, Texas, United States, 78215
Gastroenterology Clinic Of San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Tacoma Digestive Disease Research Ctr.
Tacoma, Washington, United States, 98405
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
Bruxelles, Belgium, 1200
Local Institution
Leuven, Belgium, 3000
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, 90610
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90035
Local Institution
Campinas, Sao Paulo, Brazil, 13070
Local Institution
Santo Andre - Sp, Sao Paulo, Brazil, 09060
Local Institution
Santos, Sao Paulo, Brazil, 11075
Local Institution
Rio De Janeiro, Brazil, 21941
Local Institution
Sao Paulo, Brazil, 01246
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6Z 2K5
Local Institution
Vancouver, British Columbia, Canada, V5Z 1H2
Canada, Ontario
Local Institution
Kingston, Ontario, Canada, K7L 5G2
Local Institution
London, Ontario, Canada, N6A 5A5
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
Local Institution
Toronto, Ontario, Canada, M5G 1X5
Local Institution
Toronto, Ontario, Canada, M3N 2V7
Canada, Quebec
Local Institution
Levis, Quebec, Canada, G6V 3Z1
Local Institution
Montreal, Quebec, Canada, H1T 2M4
Canada
Local Institution
Quebec, Canada, G1L 3L5
Czech Republic
Local Institution
Brno - Bohunice, Czech Republic, 625 00
Local Institution
Ceske Budejovice, Czech Republic, 370 87
France
Local Institution
Amiens Cedex 1, France, 80054
Local Institution
Clichy, France, 92110
Local Institution
Lille Cedex, France, 59037
Local Institution
Nice, France, 06200
Local Institution
Paris, France, 75475
Local Institution
Pessac, France, 33604
Local Institution
Toulouse, France, 31059
Germany
Local Institution
Kiel, Germany, 24105
Local Institution
Muenster, Germany, 48159
Local Institution
Muenster, Germany, 48129
India
Local Institution
Hyderabad, Andhra Pradesh, India, 500082
Local Institution
Kochi, Kerala, India, 682304
Local Institution
Mumbai, Maharashtra, India, 400020
Local Institution
Bangalore, India, 560017
Local Institution
Bangalore, India, 560034
Local Institution
Delhi, India, 110076
Local Institution
Hyderabad, India, 500058
Local Institution
Mangalore, India, 575001
Local Institution
Manipal, India, 576104
Local Institution
Mumbai, India, 400 022
Local Institution
Mumbai, India, 400 029
Local Institution
Mysore, India, 570004
Ireland
Local Institution
Dublin 9, Dublin, Ireland
Local Institution
Dublin, Ireland
Italy
Local Institution
Napoli, Italy, 80138
Local Institution
Padova, Italy, 35128
Local Institution
Roma, Italy, 00152
Local Institution
Roma, Italy, 00133
Local Institution
San Giovanni Rotondo, Italy, 71013
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 120-752
Mexico
Local Institution
Torreon, Coahuila, Mexico, 27250
Local Institution
Df, Distrito Federal, Mexico, 11560
Local Institution
Mexico, Distrito Federal, Mexico, 14080
Local Institution
Mexico, D. F., Distrito Federal, Mexico, 06726
Local Institution
Guadalajara, Jalisco, Mexico, 44160
Local Institution
Guadalajara, Jalisco, Mexico, 45050
Local Institution
Guadalajara, Jalisco, Mexico, 45200
Local Institution
Guadalajara, Jalisco, Mexico, 44200
Local Institution
Guadalajara, Jalisco, Mexico, 44340
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
Local Institution
Culiacan, Sinaloa, Mexico, 80230
Local Institution
Hermosillo, Sonora, Mexico, 83280
Local Institution
Chihuahua, Mexico, 31238
Netherlands
Local Institution
Amersfoort, Netherlands, 3816 CP
Local Institution
Amsterdam, Netherlands, 1105 AZ
Local Institution
Groningen, Netherlands, 9700 RB
Poland
Local Institution
Katowice, Poland, 40-752
Local Institution
Warszawa, Poland, 02-781
Local Institution
Wroclaw, Poland, 50-326
Puerto Rico
Local Institution
Ponce, Puerto Rico, 00716
South Africa
Local Institution
Parktown West, Gauteng, South Africa, 2193
Local Institution
Pretoria, Gauteng, South Africa, 0048
Local Institution
Overport, Kwa Zulu Natal, South Africa, 4091
Local Institution
Belville, Western Cape, South Africa, 7350
Local Institution
Panorama, Western Cape, South Africa, 7506
Switzerland
Local Institution
Bern, Switzerland, 3010
Local Institution
Zuerich, Switzerland, 8091
United Kingdom
Local Institution
London, Greater London, United Kingdom, WC1E 6DB
Local Institution
London, Greater London, United Kingdom, E1 1BB
Local Institution
Oxford, Oxfordshire, United Kingdom, OX 39DU
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: NCT00410410     History of Changes
Other Study ID Numbers: IM101-108
Study First Received: December 11, 2006
Results First Received: August 12, 2010
Last Updated: November 4, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Abatacept
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014