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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00534313 |
The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of patients with active arthritis due to psoriatic arthritis who have had a prior inadequate response to DMARDs, including (but not limited to) methotrexate and TNF(alpha) blockade compounds.
Condition | Intervention | Phase |
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Psoriatic Arthritis |
Drug: Abatacept Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis |
Enrollment: | 170 |
Study Start Date: | November 2007 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Active Comparator
3 mg/kg calculated dose using the subject's body weight at screening All arms (A1-A4): Open Label - Active study drug (solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing < 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing > 100 kg, monthly, LT = 18 months) |
Drug: Abatacept
solution, intravenous, monthly, ST = 24 wks
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A2: Active Comparator
10 mg/kg (fixed dose, based on subject's body weight at screening) 500 mg for subjects weighing < 60kg 750 mg for subjects weighing 60 to 100 kg and 1 gram for subjects weighing > 100 kg |
Drug: Abatacept
solution, intravenous, monthly, ST = 24 wks
|
A3: Active Comparator
30 mg/kg (calculated dose using a subject's body weight at screening) on Days 1 and 15, followed by 10 mg/kg (fixed dose, based on subject's body weight at screening0 500 mg for subjects weighing < 60kg 750 mg for subjects weighing 60 to 100 kg and 1 gram for subjects weighing > 100 kg |
Drug: Abatacept
solution, intravenous, monthly, ST = 24 wks
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A4: Placebo Comparator |
Drug: placebo
solution, intravenous, placebo (double dummy), monthly, ST = 24 wks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | IM101-158, EUDRACT 2007-004241-15 |
Study First Received: | September 20, 2007 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00534313 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Spinal Diseases Immunologic Factors Skin Diseases Arthritis, Psoriatic Joint Diseases Spondylarthropathy Immunosuppressive Agents Bone Diseases |
Abatacept Musculoskeletal Diseases Psoriasis Arthritis Antirheumatic Agents Spondylarthritis Skin Diseases, Papulosquamous Spondylarthropathies |
Spinal Diseases Immunologic Factors Skin Diseases Arthritis, Psoriatic Joint Diseases Physiological Effects of Drugs Immunosuppressive Agents Bone Diseases Pharmacologic Actions |
Abatacept Musculoskeletal Diseases Psoriasis Therapeutic Uses Arthritis Antirheumatic Agents Spondylarthritis Skin Diseases, Papulosquamous Spondylarthropathies |