Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)
NCT ID: NCT00254293
Last Updated: 2014-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
87 participants
INTERVENTIONAL
2006-01-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1 (weight < 60 kg)
Abatacept or Placebo (both as IV & SC Solution)
Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Group 2 (weight < 60 kg)
Abatacept or Placebo (both as IV & SC Solution)
Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Group 3 (weight 60-100 kg)
Abatacept or Placebo (both as IV & SC solution)
Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Group 4 (weight > 100 kg)
Abatacept or Placebo (both as IV & SC solution)
Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Group 5 (weight > 100 kg)
Abatacept or Placebo (both as IV & SC solution)
Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Abatacept
Long Term
Abatacept
Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly
Interventions
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Abatacept or Placebo (both as IV & SC Solution)
Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Abatacept or Placebo (both as IV & SC Solution)
Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Abatacept or Placebo (both as IV & SC solution)
Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Abatacept or Placebo (both as IV & SC solution)
Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Abatacept or Placebo (both as IV & SC solution)
Abatacept \& Placebo as IV \& SC solution, IV/SC, Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), 12 weeks then long term extension (LTE).
Abatacept
Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* RA diagnosis for at least 1 year.
* \> = 6 swollen joints.
* \> = 8 tender joints.
* Taking methotrexate (MTX) or MTX plus not more than 1 added oral DMARD for \> = 3 months and stable for 28 days prior to dosing.
Exclusion Criteria
* Chronic or recurrent bacterial infections.
* History of TB within previous 3 years or old TB not adequately treated.
* Specific lab test abnormalities
* History of cancer within 5 years.
* Exposure to CTLA4Ig (Cytotoxic T-lymphocyte (T-cell)-associated antigen 4Ig), belatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic.
* Treatment with hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenolate mofetil, cyclosporine, D-Penicillamine or calcineurin inhibitors.
* Exposure to live vaccines.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Orlando Clinical Research Center
Orlando, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
New Orleans Center For Clinical Research
New Orleans, Louisiana, United States
Davita Clinical Research
Minneapolis, Minnesota, United States
The Arthritis Clinic & Carolina Bone & Joint
Charlotte, North Carolina, United States
Countries
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References
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Westhovens R, Kremer JM, Moreland LW, Emery P, Russell AS, Li T, Aranda R, Becker JC, Qi K, Dougados M. Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended phase IIB study. J Rheumatol. 2009 Apr;36(4):736-42. doi: 10.3899/jrheum.080813. Epub 2009 Feb 27.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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IM101-063
Identifier Type: -
Identifier Source: org_study_id
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