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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00124982
• Date of registration: 30/06/2005
• Prospective Registration: No
• 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
• 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
• 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: Anti-Tumor Necrosing Factor (TNF) Therapy

Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Drug: Abatacept

Primary Outcome(s)

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: 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: Change From Baseline in Erythrocytes 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: 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]

LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time [Time Frame: BL, Day 365, Day 729]

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]

Long-term Period: Change From Baseline in Hematocrit 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: 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: Change From Baseline in Platelets (PLT) Over Time [Time Frame: BL, Day 365, Day 729]

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]

Short-term Period: Number of Participants With AEs of Special Interest [Time Frame: Days 1-169]

Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria [Time Frame: Days 1-169]

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]

Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure [Time Frame: Day 1 (Baseline) -Day 169]

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]

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 Other Chemistry and Urinalysis Laboratories Meeting 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]

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: 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]

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 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) 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 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: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time [Time Frame: BL, 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: 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]

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]

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]

LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA [Time Frame: Days 1-813]

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 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 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]

Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS) [Time Frame: BL]

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]

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]

Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) [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 Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP) [Time Frame: BL, Day 169]

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]

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]

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 VAS Over the Long Term [Time Frame: BL (Day 0), Days 365, 449, 533, 617, 729, 813]

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 the Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: BL, Day 169]

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]

Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response [Time Frame: BL, Day 169]

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]

Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS) [Time Frame: BL, Day 169]

Secondary ID(s)

IM101-064

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/06/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00124982