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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:  NCT00124982
Date of registration: 30/06/2005
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy
Scientific title: A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options
Date of first enrolment: April 2005
Target sample size: 1286
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00124982
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Belgium Canada Czech Republic France Germany Ireland Italy Mexico
Spain United Kingdom United States
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

Inclusion Criteria:

- Completed double-blind portion of the IM101064 study.

- Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis

- American College of Rheumatology (ACR) functional class I, II, III

- Subjects currently or previously received an anti-TNF therapy at an approved labeled
dose for at least 3 months

Exclusion Criteria:

- Subjects with active vasculitis of a major organ system (except subcutaneous
rheumatoid nodules)

- History of cancer within the last 5 years (other than non-melanoma skin cell cancers
cured by local resection)



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Drug: Anti-Tumor Necrosing Factor (TNF) Therapy
Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
Primary Outcome(s)
Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time [Time Frame: BL, Day 365, Day 729]
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time [Time Frame: BL, Day 365, Day 729]
Long-term Period: Change From Baseline in Erythrocytes Over Time [Time Frame: BL, Day 365, Day 729]
Long-term Period: Change From Baseline in Hematocrit Over Time [Time Frame: BL, Day 365, Day 729]
Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time [Time Frame: BL, Day 365, Day 729]
Long-term Period: Change From Baseline in Platelets (PLT) Over Time [Time Frame: BL, Day 365, Day 729]
Long-term Period: Change From Baseline in White Blood Cells Over Time [Time Frame: BL, Day 365, Day 729]
Long-term Period: Mean Heart Rate (HR) Over Time [Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept]
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time [Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept]
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time [Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept]
Long-term Period: Mean Temperature (T) Over Time [Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept]
Long-term Period: Number of Participants With AEs of Special Interest [Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept]
Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations [Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept]
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria [Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept]
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria [Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept]
Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria [Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept]
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria [Time Frame: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept]
LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time [Time Frame: BL, Day 365, Day 729]
Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure [Time Frame: Day 1 (Baseline) -Day 169]
Short-term Period: Number of Participants With AEs of Special Interest [Time Frame: Days 1-169]
Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations [Time Frame: Days 1-169]
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria [Time Frame: Days 1-169]
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria [Time Frame: Days 1-169]
Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria [Time Frame: Days 1-169]
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria [Time Frame: Days 1-169]
Short-term Period: 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 1-169]
Secondary Outcome(s)
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term [Time Frame: Days 365, 449, 533, 617, 729, 813]
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term [Time Frame: Days 365 and 729]
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term [Time Frame: BL (Day 0)]
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term [Time Frame: BL (Day 0)]
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]
Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term [Time Frame: BL (Day 0), Days 365, 729]
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]
Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time [Time Frame: BL, Days 365, 449, 533, 617, 729, 813]
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time [Time Frame: BL, Days 365, 449, 533, 617, 729, 813]
LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA [Time Frame: Days 1-813]
Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS) [Time Frame: BL]
Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores [Time Frame: BL]
Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS) [Time Frame: BL, Day 169]
Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP) [Time Frame: BL, Day 169]
Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) [Time Frame: BL, Day 169]
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores [Time Frame: BL, Day 169]
Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: BL, Day 169]
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label [Time Frame: BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]
Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label [Time Frame: BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169]
Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response [Time Frame: BL, Day 169]
Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169 [Time Frame: BL, Day 169]
Secondary ID(s)
IM101-064
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 02/06/2011
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00124982
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