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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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162201
First received: September 9, 2005
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Abatacept
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Abatacept
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Comparison of each subject's synovial tissue markers [ Time Frame: at baseline and after 4 months of treatment with abatacept ]

Secondary Outcome Measures:
  • 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 ]
  • assess safety & tolerability of abatacept [ Time Frame: administered for 4 months ]

Estimated Enrollment: 16
Study Start Date: December 2003
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Abatacept
Parenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 & < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months.
Other Name: Orencia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162201

Locations
United Kingdom
Local Institution
Leeds, Essex, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00162201     History of Changes
Other Study ID Numbers: IM101-015
Study First Received: September 9, 2005
Last Updated: April 11, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013