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Note: This record shows only 22 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: 19 October 2017
Main ID:  NCT00048932
Date of registration: 11/11/2002
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis
Scientific title:
Date of first enrolment: December 2002
Target sample size: 1795
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00048932
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Meet criteria of American Rheumatism Association for the diagnosis of rheumatoid
arthritis and the American College of Rheumatology functional classes I, II III or IV

- Participants must be taking 1 or more DMARDs and/or biologic approved for rheumatoid
arthritis (RA) for at least 3 months and be on a stable dose for 28 days prior to Day
1.

Exclusion:

- Other auto-immune disease as a main diagnosis (e.g. Systemic Lupus Erythematosus
[SLE], Scleroderma)

- Active tuberculosis (TB) requiring treatment within last 3 years



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Double-blind Abatacept
Drug: Double-blind Placebo
Drug: Open-label Abatacept
Primary Outcome(s)
DB; Number of Participants With AEs of Special Interest [Time Frame: Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication]
DB; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality (MA) Criteria [Time Frame: Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication]
DB; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities [Time Frame: Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337. Vital signs were measured at these visits before and after study medication infusion.]
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria [Time Frame: Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication]
Double Blind Period (DB); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation [Time Frame: Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication]
OL; Number of Participants With AEs of Special Interest [Time Frame: Day 365 to Day 1821]
OL; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities [Time Frame: Days 365 to Day 1821]
OL; Number of Participants With Electrolyte Laboratories Meeting Marked Abnormality Criteria [Time Frame: Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication]
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria [Time Frame: Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication]
OL; Number of Participants With Liver Function Laboratories Meeting Marked Abnormality Criteria [Time Frame: Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication]
OL; Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting Marked Abnormality Criteria [Time Frame: Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication]
Open Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation [Time Frame: Day 365 to Day 1,821]
Secondary Outcome(s)
DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA [Time Frame: Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337]
DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA) [Time Frame: Days 1, 29, 57, 85, 113,169, 281, 365]
Secondary ID(s)
IM101-031
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 03/05/2011
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00048932
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