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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:  NCT00409838
Date of registration: 08/12/2006
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Scientific title: A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept Administered Intravenously in Korean Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate
Date of first enrolment: April 2007
Target sample size: 113
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00409838
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Korea, Republic of
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

Key Inclusion Criteria:

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

- Patients must have been taking methotrexate for at least 3 months with at least a
weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (Day 1)

- Methotrexate weekly dose as low as 10 mg is permitted for patients who cannot tolerate
higher doses

Key Exclusion Criteria:

- Evidence (as assessed by the Investigator) of active or latent bacterial or viral
infections at the time of potential enrollment



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Drug: Methotrexate
Drug: Placebo
Primary Outcome(s)
Long-term Extension (LTE) (Open-Label) Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuatons Due to SAEs, Adverse Events (AEs), Related AEs, and Discontinuations Due to AEs [Time Frame: Day 169 to up to 56 days post the last dose (Day 1485) in the LTE period]
Percentage of Participants Meeting the Criteria of the American College of Rheumatology for 20% Improvement (ACR20) [Time Frame: At Day 169]
Secondary Outcome(s)
Abatacept Pharmacokinetic (PK) Parameters - Area Under the Curve (AUC) [Time Frame: At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113]
Abatacept Pharmacokinetic (PK) Parameters - Maximum Concentration (Cmax) [Time Frame: At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113]
Abatacept Pharmacokinetic (PK) Parameters: Time to Maximum Concentration (Tmax) and Half-Life of Elimination (T-Half) [Time Frame: At the end of infusion and 2 to 4 hours after the start of infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113]
Abatacept Pharmacokinetic (PK) Parameters: Total Body Clearance (CLT) [Time Frame: Day 29, every 28 days until Day 141]
Abatacept Pharmacokinetic (PK) Parameters: Volume at Steady State (VSS) [Time Frame: At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113]
Change From Baseline in Disease Activity Scores (DAS) Based on C-reactive Protein (DAS 28 [CRP]) Levels or Erythrocyte Sedimentation Rate (DAS 28[ESR]) [Time Frame: From Baseline to Days 169 and 1485]
Change From Baseline in Erythrocyte Sedimentation Rate [Time Frame: Days 169 to 1569]
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score [Time Frame: Day 1485]
Change From Baseline in Levels of C-reactive Protein (CRP) [Time Frame: Days 169 to 1569]
Change From Baseline in Surrogate Marker Erythrocyte Sedimentation Rate (ESR) at Day 169 [Time Frame: From Baseline to Day 169]
Change From Baseline in Surrogate Marker Rheumatoid Factor (RF) at Day 169 [Time Frame: Baseline, Day 169]
Change From Baseline to Day 169 in Analysis of Short-Form 36 (SF-36) Health Survey Questionnaire Domains [Time Frame: From Baseline to Day 169]
Change From Baseline to Day 169 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score [Time Frame: From Baseline to Day 169]
Changes From Baseline in Short-Form 36 (SF-36) Physical and Mental Health Summaries [Time Frame: At Day 1485]
Changes From Baseline in the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) Scores [Time Frame: At Days 169 and 1569]
Immunogenicity of Abatacept- Number of Participants With Reactivity Toward CTLA4-IG and CTLA4-T at Day 169 [Time Frame: Day 169]
LTE Period: Overall Number of Participants With Positive Results of Immunogenicity Samples [Time Frame: Days 169, at 6-month intervals on-treatment, and at Days 28, 56, and 85 after the last infusion of study medication in the LTE period]
Percentage of Participants Achieving ACR20, ACR50, and ACR70 Over Time [Time Frame: Days 15 through 1569]
Percentage of Participants Experiencing Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), Related SAEs and AEs, and Discontinuations Due to SAEs and AEs During the Double-Blind Period [Time Frame: Throughout double-blind study period (up to Day 169); table includes data up to 56 days past double-blind period or start of the open-label period, whichever occurred first.]
Percentage of Participants With American College of Rheumatology (ACR) ACR50 and ACR70 Response at Day 169 [Time Frame: At Day 169]
Percentage of Participants With at Least 20%, 50%, or 70% Improvement From Baseline in American College of Rheumatology (ACR) Core Components [Time Frame: From Baseline to Day 169]
Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and With EULAR-defined Remission [Time Frame: At Days 169 and 1485]
Percentage of Participants With Low Disease Activity Score (LDAS) or Who Are in Remission [Time Frame: At Days 169, 337, 729, 1149, and 1485]
Percentage of Participants With Physical Function Response as Assessed Using the Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: At Day 1485]
Summary Statistics of Minimum Observed Serum Concentration (Cmin) for Abatacept [Time Frame: At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85]
Secondary ID(s)
IM101-124
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 26/01/2010
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00409838
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