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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT00406653
Collaborator
(none)
451
Enrollment
101
Locations
3
Arms
35
Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Dec 1, 2006
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 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
    Other: 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 [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) [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 [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 [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) [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 [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) [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 [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 [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) [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) [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 [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 [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 [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: [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 [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. [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 [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) [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) [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 [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 [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) [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 [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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 University Of Alabama Medical Center Birmingham Alabama United States 35294
    2 Cedars-Sinai Medical Center Los Angeles California United States 90048
    3 The Permanente Medical Group, Inc Sacramento California United States 95825
    4 University Of Florida Gainesville Florida United States 32610
    5 Borland-Groover Clinic Jacksonville Florida United States 32256
    6 Shafran Gasteroenterology Center Winter Park Florida United States 32789
    7 Atlanta Gastroenterology Associates Atlanta Georgia United States 30342
    8 University Of Chicago Hospitals Chicago Illinois United States 60637
    9 Health Science Center Pratt Kansas United States 67124
    10 University Of Kentucky Medical Center Lexington Kentucky United States 40536
    11 University Of Louisville Louisville Kentucky United States 40202
    12 Gulf Coast Research Assoc Baton Rouge Louisiana United States 70808
    13 Vanderlick, Michael Lafayette Louisiana United States 70506
    14 Maryland Digestive Disease Research Laurel Maryland United States 20707
    15 Minnesota Gastroenterology, P.A. Plymouth Minnesota United States 55446
    16 Mayo Clinic Rochester Rochester Minnesota United States 55905
    17 Kansas City Gastroenterology And Hepatology Kansas City Missouri United States 64131
    18 Aga Clinical Research Associates, Llc Egg Harbor Twp New Jersey United States 08234
    19 Long Island Clinical Research Great Neck New York United States 11021
    20 Mount Sinai School Of Medicine New York New York United States 10029
    21 U Of Rochester Gastroenterology And Hepatology Rochester New York United States 14642
    22 University Endoscopy Center Syracuse New York United States 13210
    23 University Of North Carolina At Chapel Hill Chapel Hill North Carolina United States 27599
    24 Charlotte Gastroenterology & Hepatology, Pllc Charlotte North Carolina United States 28207
    25 Piedmont Medical Research Associates Winston Salem North Carolina United States 27103
    26 Gastroenterology Specialists, Inc. Canton Ohio United States 44718
    27 Consultants For Clinical Research Cincinnati Ohio United States 45219
    28 Gastrointestinal & Liver Diseases Consultants Dayton Ohio United States 45415
    29 Options Health Research, Llc Tulsa Oklahoma United States 74104
    30 Allegheny Center For Digestive Health Pittsburgh Pennsylvania United States 15212
    31 Southeastern Clinical Research Chattanooga Tennessee United States 37403
    32 Gastroenterology Center Of The Midsouth, P.C. Germantown Tennessee United States 38138
    33 Memphis Gastroenterology Group Germantown Tennessee United States 38138
    34 Nashville Medical Research Nashville Tennessee United States 37205
    35 Austin Gastroenterology, Pa Austin Texas United States 78705
    36 Gastroenterology Clinic Of San Antonio San Antonio Texas United States 78229
    37 Virginia Mason Medical Center Seattle Washington United States 98101
    38 Local Institution Garran Australian Capital Territory Australia 2605
    39 Local Institution Camperdown New South Wales Australia 2050
    40 Local Institution Herston Queensland Australia 4029
    41 Local Institution South Brisbane Queensland Australia 4101
    42 Local Institution Bedford Park South Australia Australia 5042
    43 Local Institution Launceston Tasmania Australia 7250
    44 Local Institution Box Hill Victoria Australia 3128
    45 Local Institution Fitzroy Victoria Australia 3065 VIC
    46 Local Institution South Ballarat Victoria Australia 3350
    47 Local Institution Fremantle Western Australia Australia 6160
    48 Local Institution Bonheiden Belgium 2820
    49 Local Institution Leuven Belgium 3000
    50 Local Institution Roeselare Belgium 8800
    51 Local Institution Salvador Bahia Brazil 42700
    52 Local Institution Goiania Goias Brazil 74535
    53 Local Institution Curitiba Parana Brazil 80060
    54 Local Institution Porto Alegre Rio Grande Do Sul Brazil 90035
    55 Local Institution Sao Paulo Brazil 01246
    56 Local Institution Calgary Alberta Canada T2N 4N1
    57 Local Institution Edmonton Alberta Canada T6G 2X8
    58 Local Institution Vancouver British Columbia Canada V6Z 2K5
    59 Local Institution St Johns Newfoundland and Labrador Canada A1B 3V6
    60 Local Institution Halifax Nova Scotia Canada B3H 2Y9
    61 Local Institution London Ontario Canada N6A 5A5
    62 Local Institution Ottawa Ontario Canada K1H 8L6
    63 Local Institution Toronto Ontario Canada M3N 2V7
    64 Local Institution Montreal Quebec Canada H1T 2M4
    65 Local Institution Ceske Budejovice Czech Republic 370 87
    66 Local Institution Aalborg Denmark 9100
    67 Local Institution Arhus C Denmark 8000
    68 Local Institution Hvidovre Denmark 2650
    69 Local Institution Odense C Denmark 5000
    70 Local Institution Amiens Cedex 1 France 80054
    71 Local Institution Lille Cedex France 59037
    72 Local Institution Nice France 06200
    73 Local Institution Paris Cedex 10 France 75475
    74 Local Institution Pessac France 33064
    75 Local Institution Toulouse Cedex France 31059
    76 Local Institution Kiel Germany 24105
    77 Local Institution Muenster Germany 48129
    78 Local Institution Muenster Germany 48159
    79 Local Institution Hyderabad Andhra Pradesh India 500082
    80 Local Institution Hyderabad India 500058
    81 Local Institution Mangalore India 575001
    82 Local Institution Manipal India 576104
    83 Local Institution Mumbai India 400 029
    84 Local Institution Mysore India 570004
    85 Local Institution Napoli Italy 80138
    86 Local Institution Padova Italy 35128
    87 Local Institution Roma Italy 00152
    88 Local Institution San Giovanni Rotondo Italy 71013
    89 Local Institution Torreon Coahuila Mexico 27250
    90 Local Institution Mexico, D.F. Distrito Federal Mexico 14000
    91 Local Institution Monterrey Nuevo Leon Mexico 64460
    92 Local Institution Amsterdam Netherlands 1105 AZ
    93 Local Institution Groningen Netherlands 9713 GZ
    94 Local Institution Rotterdam Netherlands 3015 CE
    95 Local Institution Katowice Poland 40-752
    96 Local Institution Ponce Puerto Rico 00716
    97 Local Institution Overport Kwa Zulu Natal South Africa 4091
    98 Local Institution Belville Western Cape South Africa 7535
    99 Local Institution Bern Switzerland 3010
    100 Local Institution Lausanne Switzerland 1011
    101 Local Institution Zuerich Switzerland 8091

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00406653
    Other Study ID Numbers:
    • IM101-084
    First Posted:
    Dec 4, 2006
    Last Update Posted:
    Sep 14, 2010
    Last Verified:
    Sep 1, 2010
    Additional relevant MeSH terms:
    Crohn Disease
    Abatacept

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Abatacept (ABA) 30/~10 mg/kg, Induction Period (IP) ABA ~10 mg/kg, IP ABA 3 mg/kg, IP Placebo, IP ABA ~10 mg/kg, Maintenance Period (MP) Placebo, MP ABA ~10 mg/kg, Open-Label Period (OL)
    Arm/Group Description During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group). During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered). During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose). During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57. During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1. During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
    Period Title: Induction Period
    STARTED 65 128 130 128 0 0 0
    COMPLETED 50 94 112 102 0 0 0
    NOT COMPLETED 15 34 18 26 0 0 0
    Period Title: Induction Period
    STARTED 0 0 0 0 44 46 0
    COMPLETED 0 0 0 0 14 10 0
    NOT COMPLETED 0 0 0 0 30 36 0
    Period Title: Induction Period
    STARTED 0 0 0 0 0 0 324
    COMPLETED 0 0 0 0 0 0 0
    NOT COMPLETED 0 0 0 0 0 0 324

    Baseline Characteristics

    Arm/Group Title ABA 30/~10 mg/kg, Induction Period (IP) ABA ~10 mg/kg, IP ABA 3 mg/kg, IP Placebo, IP Total
    Arm/Group Description During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group). During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered). During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose). During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57. Total of all reporting groups
    Overall Participants 65 128 130 128 451
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    36.0
    (11.12)
    38.6
    (12.90)
    36.9
    (13.35)
    38.0
    (12.98)
    37.6
    (12.81)
    Age, Customized (Number) [Number]
    <30 years
    23
    35.4%
    37
    28.9%
    51
    39.2%
    41
    32%
    152
    33.7%
    Between 30 and 50 years
    35
    53.8%
    64
    50%
    57
    43.8%
    64
    50%
    220
    48.8%
    >50 years
    7
    10.8%
    27
    21.1%
    22
    16.9%
    23
    18%
    79
    17.5%
    Sex: Female, Male (Count of Participants)
    Female
    38
    58.5%
    78
    60.9%
    78
    60%
    83
    64.8%
    277
    61.4%
    Male
    27
    41.5%
    50
    39.1%
    52
    40%
    45
    35.2%
    174
    38.6%
    Region of Enrollment (participants) [Number]
    United States
    24
    36.9%
    45
    35.2%
    46
    35.4%
    38
    29.7%
    153
    33.9%
    Italy
    0
    0%
    5
    3.9%
    5
    3.8%
    5
    3.9%
    15
    3.3%
    Switzerland
    2
    3.1%
    4
    3.1%
    3
    2.3%
    1
    0.8%
    10
    2.2%
    India
    1
    1.5%
    3
    2.3%
    2
    1.5%
    2
    1.6%
    8
    1.8%
    France
    6
    9.2%
    8
    6.3%
    7
    5.4%
    7
    5.5%
    28
    6.2%
    Czech Republic
    1
    1.5%
    2
    1.6%
    0
    0%
    2
    1.6%
    5
    1.1%
    Mexico
    1
    1.5%
    4
    3.1%
    0
    0%
    3
    2.3%
    8
    1.8%
    Puerto Rico
    1
    1.5%
    0
    0%
    0
    0%
    2
    1.6%
    3
    0.7%
    Canada
    8
    12.3%
    18
    14.1%
    22
    16.9%
    27
    21.1%
    75
    16.6%
    Brazil
    3
    4.6%
    7
    5.5%
    6
    4.6%
    6
    4.7%
    22
    4.9%
    Belgium
    2
    3.1%
    7
    5.5%
    9
    6.9%
    13
    10.2%
    31
    6.9%
    Korea, Democratic People's Republic of
    1
    1.5%
    1
    0.8%
    1
    0.8%
    1
    0.8%
    4
    0.9%
    Denmark
    1
    1.5%
    4
    3.1%
    10
    7.7%
    2
    1.6%
    17
    3.8%
    Australia
    6
    9.2%
    10
    7.8%
    13
    10%
    13
    10.2%
    42
    9.3%
    South Africa
    5
    7.7%
    5
    3.9%
    1
    0.8%
    2
    1.6%
    13
    2.9%
    Germany
    0
    0%
    2
    1.6%
    2
    1.5%
    3
    2.3%
    7
    1.6%
    Netherlands
    3
    4.6%
    3
    2.3%
    3
    2.3%
    1
    0.8%
    10
    2.2%
    Inadequate Response/Intolerance to Prior Anti-Tumor Necrosis Factor (TNF) Agent Therapy (Number) [Number]
    Inadequate Response/Intolerance To Prior Agents
    42
    64.6%
    86
    67.2%
    77
    59.2%
    77
    60.2%
    282
    62.5%
    No Inadequate Response/Intolerance To Prior Agents
    23
    35.4%
    42
    32.8%
    53
    40.8%
    51
    39.8%
    169
    37.5%
    Crohn's Disease (CD) Duration (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    8.4
    (7.49)
    9.9
    (8.74)
    9.2
    (7.98)
    9.8
    (8.29)
    9.5
    (8.21)
    Crohn's Disease Activity Index (CDAI) (points) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [points]
    320.6
    (61.59)
    318.9
    (65.08)
    317.9
    (59.87)
    320.7
    (72.09)
    319.4
    (65.03)
    Inflammatory Bowel Disease Questionnaire (IBDQ) Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    119.9
    (26.22)
    117.3
    (30.60)
    121.1
    (28.0)
    119.6
    (31.17)
    119.5
    (29.36)

    Outcome Measures

    1. Primary Outcome
    Title 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
    Description 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.
    Time Frame At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).

    Outcome Measure Data

    Analysis Population Description
    All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.
    Arm/Group Title ABA 30/~10 mg/kg, IP ABA ~10 mg/kg, IP ABA 3 mg/kg, IP Placebo, IP
    Arm/Group Description During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group). During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
    Measure Participants 64 128 129 125
    Number [participants]
    11
    16.9%
    13
    10.2%
    20
    15.4%
    18
    14.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA 30/~10 mg/kg, IP, Placebo, IP
    Comments Conditional on abatacept (ABA) 30/~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA ~10 mg/kg vs PLA to be tested at 5% significance level. Null hypothesis=no treatment difference (relative risk [RR] of ABA over placebo=1).First comparison: power=99%,sample size=134,expected PLA response rate=25%, ABA 30/~10 mg/kg=55%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.611
    Comments Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA 3mg/kg, ~10mg/kg, 30/~10mg/kg). Only ~half intended number assigned to ABA 30/~10 mg/kg arm and ~double intended number assigned to ABA 3 mg/kg arm
    Method Cochran-Mantel-Haenszel
    Comments Second primary comparison (conditional on first): power=91%, sample size=134, 5% significance; expected PLA response rate= 25%, ABA/~10 mg/kg=45%
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    0.6 to 2.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.
    2. Primary Outcome
    Title Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months)
    Description 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.
    Time Frame Day MP-365 (12 months) of maintenance therapy

    Outcome Measure Data

    Analysis Population Description
    All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. The Maintenance Period was not sized based on power considerations, and thus, no formal statistical hypothesis testing was performed.
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 42 45
    Number [participants]
    10
    15.4%
    5
    3.9%
    3. Primary Outcome
    Title 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
    Description 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.
    Time Frame Between Day OL-1 and Day OL-617

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 infusion of open-label study medication at any time, based on a participant's received treatment (As Treated Analysis Population). The OL was not sized based on power considerations.
    Arm/Group Title ABA ~10 mg/kg, OL
    Arm/Group Description During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
    Measure Participants 324
    AEs
    267
    410.8%
    Related AEs
    128
    196.9%
    Deaths
    1
    1.5%
    SAEs
    86
    132.3%
    Related SAEs
    21
    32.3%
    Discontinuation due to AE
    16
    24.6%
    4. Secondary Outcome
    Title IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome)
    Description 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.
    Time Frame At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy

    Outcome Measure Data

    Analysis Population Description
    All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period
    Arm/Group Title ABA 30/~10 mg/kg, IP ABA ~10 mg/kg, IP ABA 3 mg/kg, IP Placebo, IP
    Arm/Group Description During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group). During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
    Measure Participants 64 128 129 126
    Number [participants]
    5
    7.7%
    5
    3.9%
    6
    4.6%
    8
    6.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA 30/~10 mg/kg, IP, Placebo, IP
    Comments Conditional on abatacept (ABA) 30/~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA ~10 mg/kg vs PLA to be tested at 5% signficance level. Null hypothesis=no treatment difference (relative risk [RR] of ABA over placebo=1).First comparison: power=95%,sample size=134,expected PLA response rate=15%, ABA 30/~10 mg/kg=35%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 1.18
    Confidence Interval (2-Sided) 95%
    0.4 to 3.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.
    5. Secondary Outcome
    Title 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
    Description 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.
    Time Frame At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy

    Outcome Measure Data

    Analysis Population Description
    All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period
    Arm/Group Title Placebo, IP ABA 3 mg/kg, IP ABA ~10 mg/kg, IP ABA 30/~10 mg/kg, IP
    Arm/Group Description During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57. During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group). During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
    Measure Participants 125 129 128 64
    Number [participants]
    18
    27.7%
    20
    15.6%
    13
    10%
    11
    8.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA 30/~10 mg/kg, IP, ABA ~10 mg/kg, IP, ABA 3 mg/kg, IP, Placebo, IP
    Comments The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.436
    Comments All statistical testing was performed at a pre-specified alpha-level of 5%.
    Method Cochran-Armitage Trend Test
    Comments
    6. Secondary Outcome
    Title IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ)
    Description 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.
    Time Frame Baseline, Day IP-85

    Outcome Measure Data

    Analysis Population Description
    All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period with both Baseline and post-Baseline measurements.
    Arm/Group Title ABA 30/~10 mg/kg, IP ABA ~10 mg/kg, IP ABA 3 mg/kg, IP Placebo, IP
    Arm/Group Description During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group). During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
    Measure Participants 60 116 124 121
    Mean (Standard Deviation) [units on a scale]
    0.79
    (3.974)
    11.10
    (2.858)
    7.53
    (2.765)
    13.4
    (2.798)
    7. Secondary Outcome
    Title IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
    Description 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.
    Time Frame Day IP-1 through Day IP-85

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 infusion of study medication during the Induction Period, based on a participant's received treatment (As Treated Analysis Population)
    Arm/Group Title ABA 30/~10 mg/kg, IP ABA ~10 mg/kg, IP ABA 3 mg/kg, IP Placebo, IP
    Arm/Group Description During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group). During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
    Measure Participants 65 128 130 128
    AEs
    49
    75.4%
    97
    75.8%
    96
    73.8%
    95
    74.2%
    Related AEs
    24
    36.9%
    47
    36.7%
    46
    35.4%
    40
    31.3%
    Deaths
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    SAEs
    11
    16.9%
    22
    17.2%
    20
    15.4%
    20
    15.6%
    Related SAEs
    2
    3.1%
    7
    5.5%
    9
    6.9%
    6
    4.7%
    Discontinuation due to AE
    1
    1.5%
    11
    8.6%
    5
    3.8%
    12
    9.4%
    8. Secondary Outcome
    Title IP; Number of Participants With Adverse Events (AEs) of Special Interest
    Description 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).
    Time Frame Day IP-1 through Day IP-85

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 infusion of study medication during the IP, based on a participant's received treatment (As Treated Analysis Population)
    Arm/Group Title ABA 30/~10 mg/kg, IP ABA ~10 mg/kg, IP ABA 3 mg/kg, IP Placebo, IP
    Arm/Group Description During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group). During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
    Measure Participants 65 128 130 128
    All Infections
    13
    20%
    33
    25.8%
    31
    23.8%
    42
    32.8%
    Serious Infections
    2
    3.1%
    9
    7%
    4
    3.1%
    3
    2.3%
    Opportunistic Infections
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Malignancies-Total
    0
    0%
    0
    0%
    3
    2.3%
    0
    0%
    Malignancies-squamous cell carcinoma
    0
    0%
    0
    0%
    2
    1.5%
    0
    0%
    Malignancies-breast cancer
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Autoimmune Disorders-Total
    2
    3.1%
    1
    0.8%
    2
    1.5%
    2
    1.6%
    Autoimmune Disorders-erythema
    2
    3.1%
    1
    0.8%
    2
    1.5%
    1
    0.8%
    Autoimmune Disorders-psoriasis
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    Acute Infusional AEs
    3
    4.6%
    3
    2.3%
    4
    3.1%
    5
    3.9%
    Peri-infusional AEs
    13
    20%
    22
    17.2%
    15
    11.5%
    16
    12.5%
    9. Secondary Outcome
    Title IP; Number of Participants With Positive Antibody Response to Abatacept (ABA)
    Description 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.
    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)

    Outcome Measure Data

    Analysis Population Description
    All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.
    Arm/Group Title ABA 30/~10 mg/kg, IP ABA ~10 mg/kg, IP ABA 3 mg/kg, IP
    Arm/Group Description During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
    Measure Participants 63 123 127
    Total
    4
    6.2%
    7
    5.5%
    12
    9.2%
    CTLA4/Possibly Ig
    1
    1.5%
    0
    0%
    6
    4.6%
    Ig and/or Ig Junction
    3
    4.6%
    7
    5.5%
    6
    4.6%
    10. Secondary Outcome
    Title 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)
    Description 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.
    Time Frame At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy

    Outcome Measure Data

    Analysis Population Description
    Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.
    Arm/Group Title ABA 30/~10 mg/kg, IP ABA ~10 mg/kg, IP ABA 3 mg/kg, IP Placebo, IP
    Arm/Group Description During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group). During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
    Measure Participants 42 86 76 77
    Number [participants]
    9
    13.8%
    8
    6.3%
    2
    1.5%
    10
    7.8%
    11. Secondary Outcome
    Title 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
    Description 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.
    Time Frame At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy

    Outcome Measure Data

    Analysis Population Description
    Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.
    Arm/Group Title ABA 30/~10 mg/kg, IP ABA ~10 mg/kg, IP ABA 3 mg/kg, IP Placebo, IP
    Arm/Group Description During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group). During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
    Measure Participants 42 86 76 77
    Number [participants]
    3
    4.6%
    2
    1.6%
    0
    0%
    3
    2.3%
    12. Secondary Outcome
    Title 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
    Description 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.
    Time Frame At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy

    Outcome Measure Data

    Analysis Population Description
    Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.
    Arm/Group Title Placebo, IP ABA 3 mg/kg, IP ABA ~10 mg/kg, IP ABA 30/~10 mg/kg, IP
    Arm/Group Description During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57. During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group). During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group). During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
    Measure Participants 77 76 86 42
    Number [participants]
    10
    15.4%
    2
    1.6%
    8
    6.2%
    9
    7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABA 30/~10 mg/kg, IP, ABA ~10 mg/kg, IP, ABA 3 mg/kg, IP, Placebo, IP
    Comments The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.112
    Comments All statistical testing was performed at a pre-specified alpha-level of 5%.
    Method Cochran-Armitage Trend Test
    Comments
    13. Secondary Outcome
    Title MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs
    Description 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.
    Time Frame Between Day IP-85 and Day MP-365

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 infusion of study medication during the Maintenance Period, based on a participant's received treatment (As Treated Analysis Population)
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 44 46
    AEs
    31
    47.7%
    32
    25%
    Related AEs
    12
    18.5%
    15
    11.7%
    Deaths
    0
    0%
    0
    0%
    SAEs
    5
    7.7%
    9
    7%
    Related SAEs
    0
    0%
    1
    0.8%
    Discontinuation due to AE
    1
    1.5%
    0
    0%
    14. Secondary Outcome
    Title MP; Number of Participants With Adverse Events (AEs) of Special Interest:
    Description 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).
    Time Frame Between Day IP-85 and Day MP-365

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 infusion of study medication during the MP, based on a participant's received treatment (As Treated Analysis Population)
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 44 46
    All Infections
    16
    24.6%
    18
    14.1%
    Serious Infections
    1
    1.5%
    1
    0.8%
    Opportunistic Infections
    0
    0%
    0
    0%
    Malignancies
    0
    0%
    0
    0%
    Autoimmune Disorders-Total
    2
    3.1%
    1
    0.8%
    Autoimmune Disorders-psoriasis
    2
    3.1%
    0
    0%
    Autoimmune Disorders-erythema
    0
    0%
    1
    0.8%
    Acute Infusional AEs
    1
    1.5%
    0
    0%
    Peri-infusional AEs
    2
    3.1%
    0
    0%
    15. Secondary Outcome
    Title MP; Number of Participants With Positive Antibody Response to Abatacept
    Description 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.
    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)

    Outcome Measure Data

    Analysis Population Description
    All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population. The placebo group was constituted by participants who received abatacept in the IP and underwent drug withdrawal in the MP.
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 44 40
    Total
    7
    10.8%
    14
    10.9%
    CTLA4/Possibly Ig
    2
    3.1%
    8
    6.3%
    Ig and/or Ig Junction
    5
    7.7%
    8
    6.3%
    16. Secondary Outcome
    Title MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365.
    Description 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.
    Time Frame Day MP-365

    Outcome Measure Data

    Analysis Population Description
    All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 42 45
    Number [participants]
    11
    16.9%
    7
    5.5%
    17. Primary Outcome
    Title OL; Number of Participants With Adverse Events (AEs) of Special Interest
    Description 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).
    Time Frame Between Day OL-1 and Day OL-617

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 infusion of open-label study medication at any time, based on a participant's received treatment (As Treated Analysis Population)
    Arm/Group Title ABA ~10 mg/kg, OL
    Arm/Group Description During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
    Measure Participants 324
    All Infections
    144
    221.5%
    Serious Infections
    13
    20%
    Opportunistic Infections (OI)-Total
    2
    3.1%
    OI-oral candidiasis
    1
    1.5%
    OI-gastroenteritis Cryptosporidial
    1
    1.5%
    Malignancies-Total
    5
    7.7%
    Malignancies-basal cell carcinoma
    2
    3.1%
    Malignancies-breast cancer
    1
    1.5%
    Malignancies-squamous cell carcinoma
    1
    1.5%
    Malignancies-chronic lymphocytic leukemia
    1
    1.5%
    Autoimmune Disorders-Total
    11
    16.9%
    Autoimmune Disorders-erythema nodosum
    7
    10.8%
    Autoimmune Disorders-psoriasis
    1
    1.5%
    Autoimmune Disorders-pernicious anemia
    1
    1.5%
    Autoimmune Disorders-antiphospholipid syndrome
    1
    1.5%
    Autoimmune Disorders-ankylosing spondylitis
    1
    1.5%
    Acute Infusional AEs
    10
    15.4%
    Peri-infusional AEs
    24
    36.9%
    18. Secondary Outcome
    Title MP; Number of Participants in CDAI-defined Clinical Remission at Both Day MP-169 and Day MP-365
    Description 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.
    Time Frame Day MP-169

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for the cohort of participants with clinical remission at both Day MP-169 and Day MP-365 was not conducted for the MP as planned.
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 0 0
    19. Secondary Outcome
    Title MP; Change From Baseline to Day MP-365 in Short Form-36 (SF-36)
    Description 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.
    Time Frame Baseline, Day MP-365

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in SF-36 responses were not conducted for the MP as planned.
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 0 0
    20. Secondary Outcome
    Title MP; Change From Baseline to Day MP-365 in Inflammatory Bowel Disease Questionnaire (IBDQ)
    Description 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.
    Time Frame Baseline, Day MP-365

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in IBDQ responses were not conducted for the MP as planned.
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 0 0
    21. Secondary Outcome
    Title MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among All Participants Who Received Baseline Corticosteroid Therapy
    Description 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.
    Time Frame Day MP-365

    Outcome Measure Data

    Analysis Population Description
    On/after Day MP-1, a recommended tapering of corticosteroids was planned if participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 0 0
    22. Secondary Outcome
    Title 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
    Description 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.
    Time Frame Day MP-365

    Outcome Measure Data

    Analysis Population Description
    On/after Day MP-1, a defined tapering of corticosteroids was planned if the participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 0 0
    23. Secondary Outcome
    Title MP; Number of Participants With CDAI-Defined Clinical Response Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)
    Description 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.
    Time Frame Day MP-365

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical response in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 0 0
    24. Secondary Outcome
    Title MP; Number of Participants in CDAI-Defined Clinical Remission Among Participants With Inadequate Response and/or Intolerance to Anti-TNF
    Description 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.
    Time Frame Day MP-365

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical remission in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.
    Arm/Group Title ABA ~10 mg/kg, MP Placebo, MP
    Arm/Group Description During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    Measure Participants 0 0
    25. Secondary Outcome
    Title OL; Number of Participants Who Were Not On Background Corticosteroid Therapy Among All Participants Who Received Baseline Corticosteroid Therapy
    Description Background corticosteroid therapy included prednisone or budesonide.
    Time Frame Between Day OL-1 and Day OL-617

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of corticosteroid use in participants was not conducted for the OL as planned.
    Arm/Group Title ABA ~10 mg/kg, OL
    Arm/Group Description During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
    Measure Participants 0
    26. Secondary Outcome
    Title OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169
    Description 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.
    Time Frame Day OL-169

    Outcome Measure Data

    Analysis Population Description
    All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.
    Arm/Group Title ABA ~10 mg/kg, OL
    Arm/Group Description During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
    Measure Participants 163
    Clinical Response
    84
    129.2%
    Clinical Remission
    55
    84.6%
    27. Secondary Outcome
    Title OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365
    Description 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.
    Time Frame Day OL-365

    Outcome Measure Data

    Analysis Population Description
    All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.
    Arm/Group Title ABA ~10 mg/kg, OL
    Arm/Group Description During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
    Measure Participants 69
    Clinical Response
    35
    53.8%
    Clinical Remission
    24
    36.9%
    28. Secondary Outcome
    Title OL; Number of Participants With Positive Antibody Response to Abatacept
    Description 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.
    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)

    Outcome Measure Data

    Analysis Population Description
    All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.
    Arm/Group Title ABA ~10 mg/kg, OL
    Arm/Group Description During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
    Measure Participants 314
    Total
    71
    109.2%
    CTLA4/Possibly Ig
    46
    70.8%
    Ig and/or Ig Junction
    29
    44.6%
    29. Secondary Outcome
    Title OL; Number of Participants With Pharmacogenomic Marker Activity
    Description 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.
    Time Frame Between Day OL-1 and Day OL-617

    Outcome Measure Data

    Analysis Population Description
    Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of pharmacogenomic marker activity in participants was not conducted for the OL as planned.
    Arm/Group Title ABA ~10 mg/kg, OL
    Arm/Group Description During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
    Measure Participants 0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title ABA 30/~10mg/kg (IP) ABA 3mg/kg (IP) ABA ~10mg/kg (IP) ABA ~10mg/kg (MP) ABA ~10mg/kg (OL) Placebo (IP) Placebo (MP)
    Arm/Group Description During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group). During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose). During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered). During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1. During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1. During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57. During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
    All Cause Mortality
    ABA 30/~10mg/kg (IP) ABA 3mg/kg (IP) ABA ~10mg/kg (IP) ABA ~10mg/kg (MP) ABA ~10mg/kg (OL) Placebo (IP) Placebo (MP)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    ABA 30/~10mg/kg (IP) ABA 3mg/kg (IP) ABA ~10mg/kg (IP) ABA ~10mg/kg (MP) ABA ~10mg/kg (OL) Placebo (IP) Placebo (MP)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 11/65 (16.9%) 20/130 (15.4%) 22/128 (17.2%) 5/44 (11.4%) 86/324 (26.5%) 20/128 (15.6%) 9/46 (19.6%)
    Cardiac disorders
    TACHYCARDIA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    SINUS TACHYCARDIA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    Eye disorders
    EPISCLERITIS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 1/128 (0.8%) 0/46 (0%)
    Gastrointestinal disorders
    NAUSEA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    SUBILEUS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    VOMITING 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 2/324 (0.6%) 0/128 (0%) 0/46 (0%)
    DIARRHOEA 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    PROCTALGIA 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    ODYNOPHAGIA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    ANAL FISTULA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 1/46 (2.2%)
    CONSTIPATION 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    ACUTE ABDOMEN 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 2/324 (0.6%) 0/128 (0%) 0/46 (0%)
    ABDOMINAL PAIN 0/65 (0%) 2/130 (1.5%) 0/128 (0%) 1/44 (2.3%) 3/324 (0.9%) 0/128 (0%) 0/46 (0%)
    ILEAL STENOSIS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    CROHN'S DISEASE 5/65 (7.7%) 9/130 (6.9%) 9/128 (7%) 2/44 (4.5%) 35/324 (10.8%) 10/128 (7.8%) 3/46 (6.5%)
    MOUTH ULCERATION 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    ABDOMINAL PAIN LOWER 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    INTESTINAL OBSTRUCTION 0/65 (0%) 1/130 (0.8%) 1/128 (0.8%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    INTESTINAL PERFORATION 1/65 (1.5%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    SMALL INTESTINAL STENOSIS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    GASTROINTESTINAL DYSPLASIA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    LARGE INTESTINE PERFORATION 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    GASTROINTESTINAL HAEMORRHAGE 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 1/46 (2.2%)
    SMALL INTESTINAL OBSTRUCTION 1/65 (1.5%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 3/324 (0.9%) 0/128 (0%) 1/46 (2.2%)
    General disorders
    PYREXIA 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 2/324 (0.6%) 0/128 (0%) 0/46 (0%)
    ASTHENIA 1/65 (1.5%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    CHEST PAIN 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 1/128 (0.8%) 1/46 (2.2%)
    CHEST DISCOMFORT 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    INFLUENZA LIKE ILLNESS 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 0/324 (0%) 1/128 (0.8%) 0/46 (0%)
    Hepatobiliary disorders
    CHOLELITHIASIS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    CHOLECYSTITIS ACUTE 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 2/324 (0.6%) 0/128 (0%) 0/46 (0%)
    Immune system disorders
    HYPERSENSITIVITY 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 1/128 (0.8%) 0/46 (0%)
    DRUG HYPERSENSITIVITY 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 1/128 (0.8%) 0/46 (0%)
    TYPE I HYPERSENSITIVITY 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    ANTIPHOSPHOLIPID SYNDROME 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    Infections and infestations
    ABSCESS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    FURUNCLE 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    PNEUMONIA 0/65 (0%) 1/130 (0.8%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    BRONCHITIS 1/65 (1.5%) 0/130 (0%) 0/128 (0%) 1/44 (2.3%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    CELLULITIS 0/65 (0%) 0/130 (0%) 2/128 (1.6%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    HEPATITIS B 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    ANAL ABSCESS 0/65 (0%) 3/130 (2.3%) 4/128 (3.1%) 0/44 (0%) 3/324 (0.9%) 1/128 (0.8%) 0/46 (0%)
    OSTEOMYELITIS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    PELVIC ABSCESS 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    VULVAL ABSCESS 1/65 (1.5%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    ACARODERMATITIS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    GASTROENTERITIS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 2/324 (0.6%) 0/128 (0%) 0/46 (0%)
    ABDOMINAL ABSCESS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 1/128 (0.8%) 0/46 (0%)
    ABSCESS INTESTINAL 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 1/128 (0.8%) 0/46 (0%)
    GASTROENTERITIS VIRAL 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    URINARY TRACT INFECTION 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    CLOSTRIDIUM DIFFICILE COLITIS 1/65 (1.5%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 3/324 (0.9%) 0/128 (0%) 1/46 (2.2%)
    Injury, poisoning and procedural complications
    FEMUR FRACTURE 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    INCISIONAL HERNIA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 1/128 (0.8%) 0/46 (0%)
    BURNS SECOND DEGREE 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    ROAD TRAFFIC ACCIDENT 0/65 (0%) 0/130 (0%) 0/128 (0%) 1/44 (2.3%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    THERAPEUTIC AGENT TOXICITY 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    Metabolism and nutrition disorders
    DEHYDRATION 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 1/46 (2.2%)
    HYPOKALAEMIA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    HYPOVOLAEMIA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    MALNUTRITION 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 1/128 (0.8%) 0/46 (0%)
    Musculoskeletal and connective tissue disorders
    ARTHRITIS 0/65 (0%) 1/130 (0.8%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    BACK PAIN 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    ARTHRALGIA 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 2/324 (0.6%) 0/128 (0%) 0/46 (0%)
    MUSCLE SPASMS 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    OSTEONECROSIS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    MUSCULOSKELETAL PAIN 0/65 (0%) 1/130 (0.8%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    OSTEOPOROTIC FRACTURE 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BREAST CANCER 0/65 (0%) 1/130 (0.8%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    BASAL CELL CARCINOMA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 2/324 (0.6%) 0/128 (0%) 0/46 (0%)
    PITUITARY TUMOUR BENIGN 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    CHRONIC LYMPHOCYTIC LEUKAEMIA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    SQUAMOUS CELL CARCINOMA OF SKIN 0/65 (0%) 2/130 (1.5%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    Nervous system disorders
    HEADACHE 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    TRANSIENT ISCHAEMIC ATTACK 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    COMPLEX REGIONAL PAIN SYNDROME 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    Psychiatric disorders
    ANXIETY 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    DEPRESSION 1/65 (1.5%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    SUICIDE ATTEMPT 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    MAJOR DEPRESSION 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    Renal and urinary disorders
    URETHRAL CYST 1/65 (1.5%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    NEPHROLITHIASIS 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    CALCULUS URETERIC 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 1/44 (2.3%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    Reproductive system and breast disorders
    MENORRHAGIA 1/65 (1.5%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    OVARIAN CYST 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 0/65 (0%) 0/130 (0%) 1/128 (0.8%) 0/44 (0%) 0/324 (0%) 0/128 (0%) 0/46 (0%)
    DYSPNOEA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 2/324 (0.6%) 0/128 (0%) 0/46 (0%)
    PULMONARY EMBOLISM 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    RESPIRATORY TRACT CONGESTION 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    Skin and subcutaneous tissue disorders
    PURPURA 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    Vascular disorders
    EMBOLISM 0/65 (0%) 0/130 (0%) 0/128 (0%) 0/44 (0%) 1/324 (0.3%) 0/128 (0%) 0/46 (0%)
    DEEP VEIN THROMBOSIS 0/65 (0%) 0/130 (0%) 2/128 (1.6%) 0/44 (0%) 1/324 (0.3%) 1/128 (0.8%) 0/46 (0%)
    Other (Not Including Serious) Adverse Events
    ABA 30/~10mg/kg (IP) ABA 3mg/kg (IP) ABA ~10mg/kg (IP) ABA ~10mg/kg (MP) ABA ~10mg/kg (OL) Placebo (IP) Placebo (MP)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 34/65 (52.3%) 48/130 (36.9%) 45/128 (35.2%) 19/44 (43.2%) 150/324 (46.3%) 60/128 (46.9%) 17/46 (37%)
    Gastrointestinal disorders
    NAUSEA 6/65 (9.2%) 11/130 (8.5%) 9/128 (7%) 5/44 (11.4%) 35/324 (10.8%) 9/128 (7%) 2/46 (4.3%)
    VOMITING 5/65 (7.7%) 3/130 (2.3%) 2/128 (1.6%) 3/44 (6.8%) 23/324 (7.1%) 8/128 (6.3%) 4/46 (8.7%)
    ABDOMINAL PAIN 4/65 (6.2%) 3/130 (2.3%) 7/128 (5.5%) 3/44 (6.8%) 26/324 (8%) 7/128 (5.5%) 3/46 (6.5%)
    MOUTH ULCERATION 1/65 (1.5%) 1/130 (0.8%) 1/128 (0.8%) 3/44 (6.8%) 3/324 (0.9%) 0/128 (0%) 0/46 (0%)
    General disorders
    FATIGUE 5/65 (7.7%) 8/130 (6.2%) 4/128 (3.1%) 3/44 (6.8%) 22/324 (6.8%) 10/128 (7.8%) 0/46 (0%)
    PYREXIA 9/65 (13.8%) 4/130 (3.1%) 5/128 (3.9%) 0/44 (0%) 21/324 (6.5%) 10/128 (7.8%) 4/46 (8.7%)
    Infections and infestations
    INFLUENZA 1/65 (1.5%) 2/130 (1.5%) 3/128 (2.3%) 1/44 (2.3%) 13/324 (4%) 3/128 (2.3%) 3/46 (6.5%)
    BRONCHITIS 0/65 (0%) 1/130 (0.8%) 2/128 (1.6%) 3/44 (6.8%) 6/324 (1.9%) 2/128 (1.6%) 0/46 (0%)
    NASOPHARYNGITIS 1/65 (1.5%) 7/130 (5.4%) 2/128 (1.6%) 1/44 (2.3%) 25/324 (7.7%) 5/128 (3.9%) 4/46 (8.7%)
    URINARY TRACT INFECTION 1/65 (1.5%) 6/130 (4.6%) 3/128 (2.3%) 1/44 (2.3%) 18/324 (5.6%) 7/128 (5.5%) 1/46 (2.2%)
    UPPER RESPIRATORY TRACT INFECTION 1/65 (1.5%) 5/130 (3.8%) 0/128 (0%) 3/44 (6.8%) 25/324 (7.7%) 6/128 (4.7%) 3/46 (6.5%)
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 7/65 (10.8%) 9/130 (6.9%) 7/128 (5.5%) 3/44 (6.8%) 27/324 (8.3%) 8/128 (6.3%) 3/46 (6.5%)
    Nervous system disorders
    HEADACHE 7/65 (10.8%) 12/130 (9.2%) 13/128 (10.2%) 2/44 (4.5%) 30/324 (9.3%) 8/128 (6.3%) 3/46 (6.5%)
    DIZZINESS 4/65 (6.2%) 4/130 (3.1%) 3/128 (2.3%) 0/44 (0%) 3/324 (0.9%) 3/128 (2.3%) 1/46 (2.2%)
    Skin and subcutaneous tissue disorders
    RASH 4/65 (6.2%) 2/130 (1.5%) 1/128 (0.8%) 1/44 (2.3%) 10/324 (3.1%) 2/128 (1.6%) 1/46 (2.2%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/Title BMS Study Director
    Organization Bristol-Myers Squibb
    Phone
    Email Clinical.Trials@bms.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00406653
    Other Study ID Numbers:
    • IM101-084
    First Posted:
    Dec 4, 2006
    Last Update Posted:
    Sep 14, 2010
    Last Verified:
    Sep 1, 2010