A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

• 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
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Contacts

• Name: Bristol-Myers Squibb
• 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: Methotrexate

Drug: Placebo

Drug: Abatacept

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 - 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]

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]

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]

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 Physical Function Response as Assessed Using the Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: At Day 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 Rheumatoid Factor (RF) at Day 169 [Time Frame: Baseline, 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]

Change From Baseline to Day 169 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score [Time Frame: From Baseline to Day 169]

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.]

Abatacept Pharmacokinetic (PK) Parameters: Total Body Clearance (CLT) [Time Frame: Day 29, every 28 days until Day 141]

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]

Immunogenicity of Abatacept- Number of Participants With Reactivity Toward CTLA4-IG and CTLA4-T at Day 169 [Time Frame: Day 169]

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: 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]

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]

Changes From Baseline in Short-Form 36 (SF-36) Physical and Mental Health Summaries [Time Frame: At Day 1485]

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 Low Disease Activity Score (LDAS) or Who Are in Remission [Time Frame: At Days 169, 337, 729, 1149, and 1485]

Change From Baseline in Surrogate Marker Erythrocyte Sedimentation Rate (ESR) at Day 169 [Time Frame: From Baseline to 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]

Percentage of Participants With American College of Rheumatology (ACR) ACR50 and ACR70 Response at Day 169 [Time Frame: At Day 169]

Secondary ID(s)

IM101-124

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/01/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00409838