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Clinical Trials/NCT00124449
NCT00124449CompletedPhase 2

A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

Bristol-Myers Squibb1 site in 1 country56 target enrollmentStarted: February 2005Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
56
Locations
1
Primary Endpoint
Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosis of undifferentiated arthritis
  • •Clinical synovitis of two or more joints
  • •At least one but not more than three of the criteria for diagnosis of RA (1987).
  • •No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics.
  • •Duration of disease must be 18 months or less.
  • •Positive for antibodies against cyclic citrullinated peptides.

Exclusion Criteria

  • •Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy.
  • •Active vasculitis of a major organ system.
  • •Severe or recurrent bacterial infection.
  • •History of cancer in the last five years except certain skin cancers.
  • •Herpes zoster that resolved less than 2 months prior to enrollment

Arms & Interventions

1

Active Comparator

Intervention: Abatacept (Drug)

2

Placebo Comparator

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy

Time Frame: 12 months

ARA criteria is a 7-item tool for RA classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting primary endpoint also.

Secondary Outcomes

  • Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy(24 months)
  • Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease(12 months, 24 months)
  • Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months(Baseline, 6 months, 12 months, 24 months)
  • Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months(Baseline, 6 months, 12 months, 24 months)
  • Number of Participants With Persistent Symptomatic Clinical Synovitis(6, 12, and 24 months)
  • Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline(6 months, 12 months, 24 months)
  • Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months(Baseline, 6 Months, 12 months, 24 months)
  • Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time(Day 1, 6 months, 12 months, 24 months)
  • Frequency of Human Leukocyte Antigen (HLA) Typing(Day 1)
  • DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline(6 months, 12 months, 24 months)
  • Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)(6 months, 12 months, 24 months)
  • Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response(6 months, 12 months, 24 months)
  • Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths(Throughout the treatment period (6 months))
  • Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies(Up to 12 months)

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry

Study Sites (1)

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