Clinical trial NCT00989235: Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis
Official title: A Phase 3B, Multi-Center, Randomized, Double-blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate-naïve Early Erosive Rheumatoid Arthritis Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate - Low Dose Sub-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: NOS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-10-05
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (Disease Activity Score 28 \[DAS 28\]-erythrocyte sedimentation rate \[ESR\] \< 2.6) at Day 701 of study IM101023.


Eligibility criteria: Inclusion Criteria:

* Subjects who have completed the main study, are willing to participate and have a DAS 28 ESR score of \< 2.6 on Day 701 of the main study

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
timeFrame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary outcomes:
measure: Number of Participants Experiencing Disease Relapse
timeFrame: After 12 Months of treatment
measure: Mean Time-Matched Baseline DAS28 CRP Scores
timeFrame: Baseline
measure: Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
timeFrame: Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365
measure: Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status)
timeFrame: After 12 months of treatment
measure: Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment
timeFrame: After 12 months of treatment
measure: Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids
timeFrame: After 12 months of treatment
measure: Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment
timeFrame: After 12 months of treatment
measure: Percentage of Participants Who Modified Therapy During Double-Blind Treatment
timeFrame: After 12 months of treatment
measure: Percentage of Participants Who Lost Remission Status
timeFrame: After 12 months of treatment
measure: Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment
timeFrame: Day 701 of the main study; sub-study Days 1, 85, 169, 253
measure: Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment
timeFrame: From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
measure: Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
timeFrame: From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
measure: Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment
timeFrame: From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
measure: Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity
timeFrame: From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
measure: Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
timeFrame: From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
measure: Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
timeFrame: From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
measure: Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
timeFrame: From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
measure: Clinically Significant Changes in Vital Signs and Physical Findings
timeFrame: From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
measure: Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment
timeFrame: After 12 months of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Westhovens R, Robles M, Ximenes AC, Wollenhaupt J, Durez P, Gomez-Reino J, Grassi W, Haraoui B, Shergy W, Park SH, Genant H, Peterfy C, Becker JC, Murthy B. Maintenance of remission following 2 years of standard treatment then dose reduction with abatacept in patients with early rheumatoid arthritis and poor prognosis. Ann Rheum Dis. 2015 Mar;74(3):564-8. doi: 10.1136/annrheumdis-2014-206149. Epub 2014 Dec 30.