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
Key
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest
Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.
From Day 169 to Day 729
Yes
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
IM101-158
NCT00534313
November 2007
May 2011
Name | Location |
---|---|
Stanford University School of Medicine | Stanford, California 94305-5317 |
Altoona Center for Clinical Research | Duncansville, Pennsylvania 16635 |
Rheumatology Associates Of North Alabama | Huntsville, Alabama 35801 |
New England Research Associates, Llc | Trumbull, Connecticut 06611 |
Health Research Of Oklahoma | Oklahoma City, Oklahoma 73103 |
Desert Medical Advances | Palm Desert, California 92260 |
Boling Clinical Trials | Upland, California 91786 |
Clinical Pharmacology Study Group | Worcester, Massachusetts 01610 |
Joao Nascimento | Bridgeport, Connecticut 06606 |
Sarasota Arthritis Research Center | Sarasota, Florida 34239 |
Justus Fiechtner, Md, Mph | Lansing, Michigan 48910 |
St. Paul Rheumatology P.A. | Eagan, Minnesota 55121 |
Midwest Arthritis Center | Kalamazoo, Minnesota 49048 |
Arthritis Clinic & Carolina Bone & Joint, Pa | Charlotte, North Carolina 28210 |
Deaconess Hospital | Cincinnati, Ohio 45219 |
Rheumatic Disease Associates, Ltd. | Willow Grove, Pennsylvania 19090 |
Chase, Walter F. | Austin, Texas 78705 |
Seattle Rheumatology Associates | Seattle, Washington 98104 |
Arthritis Northwest | Spokane, Washington 99204 |