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Completed

NCT Number: NCT00162201

An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy

Study to assess changes in synovial tissue before and after treatment with Abatacept in subjects with RA who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-TNF (tumor necrosing factor)blocking agents.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Leeds, Essex, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • RA for at least 1 year
  • Clear clinical signs of active RA in 1 knee joint
  • Meet ARA (1987) criteria for diagnosis of RA and ACR (1991) criteria for RA functional classes I, II, or III
  • Inadequate clinical response to a minimum of 3 months of therapy with anti-TNF-blocking agents
  • Taking background DMARDs for a minimum of 3 months and at stable doses for at least 28 days

Exclusion criteria

  • Serious bacterial infection in last 3 months
  • History of TB
  • History of cancer within 5 years
  • Evidence of latent or active bacterial or viral infection
  • Intra-articular corticosteroids within 3 months
  • Exposure to live vaccines
  • Exposure to CTLA4Ig or BMS-188667
  • Treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, D-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents

Treatment and study plan

Abatacept

Drug

Parenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 & < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months.

Other names: Orencia

Primary outcomes

  1. Comparison of each subject's synovial tissue markers

    Time frame: at baseline and after 4 months of treatment with abatacept

Secondary outcomes

  1. assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum

    Time frame: after 4 months of treatment

  2. assess safety & tolerability of abatacept

    Time frame: administered for 4 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 13, 2005
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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