Back to resultsAn 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
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Abatacept
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility 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
Sites / Locations
- Local Institution
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Comparison of each subject's synovial tissue markers
Secondary Outcome Measures
assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum
assess safety & tolerability of abatacept
Full Information
NCT ID
NCT00162201
First Posted
September 9, 2005
Last Updated
January 11, 2017
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00162201
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Abatacept
Other Intervention Name(s)
Orencia
Intervention Description
Parenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 & < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months.
Primary Outcome Measure Information:
Title
Comparison of each subject's synovial tissue markers
Time Frame
at baseline and after 4 months of treatment with abatacept
Secondary Outcome Measure Information:
Title
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
Title
assess safety & tolerability of abatacept
Time Frame
administered for 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Leeds
State/Province
Essex
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
18772191
Citation
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. doi: 10.1136/ard.2008.091876. Epub 2008 Sep 4. Erratum In: Ann Rheum Dis. 2011 Aug;70(8):1519.
Results Reference
background
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
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
We'll reach out to this number within 24 hrs