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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00406653
Date of registration: 01/12/2006
Primary sponsor: Bristol-Myers Squibb
Public title: A Study of Abatacept in Patients With Active Crohn's Disease
Scientific 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
Date of first enrolment: December 2006
Target sample size: 451
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT00406653
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Countries of recruitment
Argentina Australia Belgium Brazil Canada Czech Republic Denmark France
Germany India Ireland Italy Korea, Republic of Mexico Netherlands Poland
Puerto Rico South Africa Spain Switzerland United Kingdom United States
Contacts
Name:   Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years or older

- have had Crohn's Disease for at least 3 months

- moderate to severely active Crohn's Disease

- have had an inadequate response or intolerance to other Crohn's Disease treatments



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: abatacept
Drug: placebo
Primary Outcome(s)
Induction Period (IP); Number of Participants With Crohn's Disease Activity Index (CDAI)-Defined Clinical Response at Both Day IP-57 and Day IP-85 [Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).]
Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months) [Time Frame: Day MP-365 (12 months) of maintenance therapy]
OL; Number of Participants With Adverse Events (AEs) of Special Interest [Time Frame: Between Day OL-1 and Day OL-617]
Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs [Time Frame: Between Day OL-1 and Day OL-617]
Secondary Outcome(s)
IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ) [Time Frame: Baseline, Day IP-85]
IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome) [Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy]
IP; Number of Participants in CDAI-Defined Clinical Remission at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-TNF [Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy]
IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship [Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy]
IP; Number of Participants With Adverse Events (AEs) of Special Interest [Time Frame: Day IP-1 through Day IP-85]
IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs [Time Frame: Day IP-1 through Day IP-85]
IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF) [Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy]
IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship [Time Frame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy]
IP; Number of Participants With Positive Antibody Response to Abatacept (ABA) [Time Frame: For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85); For participants treated in OL directly after IP: Day IP-1 to Day OL-1; For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)]
MP; Change From Baseline to Day MP-365 in Inflammatory Bowel Disease Questionnaire (IBDQ) [Time Frame: Baseline, Day MP-365]
MP; Change From Baseline to Day MP-365 in Short Form-36 (SF-36) [Time Frame: Baseline, Day MP-365]
MP; Number of Participants in CDAI-Defined Clinical Remission Among Participants With Inadequate Response and/or Intolerance to Anti-TNF [Time Frame: Day MP-365]
MP; Number of Participants in CDAI-defined Clinical Remission at Both Day MP-169 and Day MP-365 [Time Frame: Day MP-169]
MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among All Participants Who Received Baseline Corticosteroid Therapy [Time Frame: Day MP-365]
MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among Participants Who Received Baseline Corticosteroid Therapy and Who Achieved CDAI-Defined Clinical Remission [Time Frame: Day MP-365]
MP; Number of Participants With Adverse Events (AEs) of Special Interest: [Time Frame: Between Day IP-85 and Day MP-365]
MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs [Time Frame: Between Day IP-85 and Day MP-365]
MP; Number of Participants With CDAI-Defined Clinical Response Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF) [Time Frame: Day MP-365]
MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365. [Time Frame: Day MP-365]
MP; Number of Participants With Positive Antibody Response to Abatacept [Time Frame: For participants not entering OL: All measurements after Day MP-1 (including follow-up visits); For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1)]
OL; Number of Participants Who Were Not On Background Corticosteroid Therapy Among All Participants Who Received Baseline Corticosteroid Therapy [Time Frame: Between Day OL-1 and Day OL-617]
OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169 [Time Frame: Day OL-169]
OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365 [Time Frame: Day OL-365]
OL; Number of Participants With Pharmacogenomic Marker Activity [Time Frame: Between Day OL-1 and Day OL-617]
OL; Number of Participants With Positive Antibody Response to Abatacept [Time Frame: For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)]
Secondary ID(s)
IM101-084
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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