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.

First Received: September 9, 2005 Last Updated: August 13, 2008 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162201

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacodynamics Study
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:

MedlinePlus related topics: Rheumatoid Arthritis

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

Arms	Assigned Interventions
1: Experimental	Drug: Abatacept Parenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 & < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months.

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, Essex
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

No publications provided

Study ID Numbers:	IM101-015
Study First Received:	September 9, 2005
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00162201 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Abatacept
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 11, 2009