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

September 9, 2005
April 11, 2011
December 2003
April 2005   (final data collection date for primary outcome measure)
Comparison of each subject's synovial tissue markers [ Time Frame: at baseline and after 4 months of treatment with abatacept ]
Comparison of each subject's synovial tissue markers at baseline and after 4 months of treatment with abatacept
Complete list of historical versions of study NCT00162201 on ClinicalTrials.gov Archive Site
  • 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 ]
assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum after 4 months of treatment; assess safety & tolerability of abatacept administered for 4 months
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
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
Experimental: 1
Intervention: Drug: Abatacept
Buch MH, Boyle DL, Rosengren S, Saleem B, Reece RJ, Rhodes LA, Radjenovic A, English A, Tang H, Vratsanos G, O'Connor P, Firestein GS, Emery P. Mode of action of abatacept in rheumatoid arthritis patients having failed tumour necrosis factor blockade: a histological, gene expression and dynamic magnetic resonance imaging pilot study. Ann Rheum Dis. 2009 Jul;68(7):1220-7. Epub 2008 Sep 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
April 2005
April 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00162201
IM101-015
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP