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

NCT00409838 | Completed Phase 3 Results

• 1 other identifier: IM101-124
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and an inadequate clinical response to methotrexate

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, with inadequate response to methotrexate

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Meeting the Criteria of the American College of Rheumatology for 20% Improvement (ACR20)

  The ACR 20 is based on 20% improvement (compared with baseline values) in tender and swollen joint counts and on 20% improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.

  At Day 169

• 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

  AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.

  Day 169 to up to 56 days post the last dose (Day 1485) in the LTE period

Secondary Outcomes (25)

• Percentage of Participants With American College of Rheumatology (ACR) ACR50 and ACR70 Response at Day 169

  At Day 169

• Percentage of Participants With at Least 20%, 50%, or 70% Improvement From Baseline in American College of Rheumatology (ACR) Core Components

  From Baseline to Day 169

• Change From Baseline in Disease Activity Scores (DAS) Based on C-reactive Protein (DAS 28 [CRP]) Levels or Erythrocyte Sedimentation Rate (DAS 28[ESR])

  From Baseline to Days 169 and 1485

• Change From Baseline to Day 169 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score

  From Baseline to Day 169

• Change From Baseline to Day 169 in Analysis of Short-Form 36 (SF-36) Health Survey Questionnaire Domains

  From Baseline to Day 169

Study Arms (3)

Abatacept and Methotrexate

EXPERIMENTAL

Drug: Abatacept; Drug: Methotrexate

Placebo and Methotrexate

PLACEBO COMPARATOR

(standard of care)

Drug: Methotrexate; Drug: Placebo

Abatacept - Open Label

EXPERIMENTAL

Open-label extension phase

Drug: Abatacept; Drug: Methotrexate

Interventions

Abatacept DRUG

Intravenous (IV) solution, - weight tiered (500 mg \<60 kg); (750 mg 60-100 kg); (1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months

Also known as: Orencia, BMS-188667

Abatacept and Methotrexate

Methotrexate DRUG

Tablets, Oral, ≥ 15 mg, weekly, 6 months

Abatacept and Methotrexate; Placebo and Methotrexate

Placebo DRUG

IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months

Placebo and Methotrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (7)

Local Institution

Seoul, Sungdong-Gu, 133-792, South Korea

Location

Local Institution

Anyang, 431-070, South Korea

Location

Local Institution

Daegu, 705-718, South Korea

Location

Local Institution

Daejeon, 302-799, South Korea

Location

Local Institution

Seoul, 110-744, South Korea

Location

Local Institution

Seoul, 137-040, South Korea

Location

Local Institution

Seoul, 138-736, South Korea

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 11, 2006
• Study Start: April 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: December 1, 2011
• Last Updated: August 8, 2013
• Results First Posted: January 26, 2010

Record last verified: 2013-08

Locations

KR (7)