Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
NCT ID: NCT00534313
Last Updated: 2012-08-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
191 participants
INTERVENTIONAL
2007-11-30
2011-05-31
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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Abatacept (30/10)
Abatacept (30 mg/kg) was administered as intravenous (iv) infusion over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants for dosing on Days 1 and 15 followed by fixed dosing as per rheumatoid arthritis label (participants weighing \<60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \>100 kg received 1000 mg) thereafter.
Abatacept
Solution, intravenous, monthly, short-term = 24 weeks (6 months)
Abatacept (10/10)
Abatacept (10 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 in the double-blind period and continued for next 18 months in the open-label period till Day 729. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing \<60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \>100 kg received 1000 mg).
Abatacept
Solution, intravenous, monthly, short-term = 24 weeks (6 months)
Abatacept (3/3)
Abatacept (3 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants.
Abatacept
Solution, intravenous, monthly, short-term = 24 weeks (6 months)
Placebo
Placebo solution (5% dextrose in water for injection, 0.9% sodium chloride injection) by iv infusion was administered on Days 1, 15, and 29 and every 28 days thereafter till Day 141.
Placebo
Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)
Interventions
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Abatacept
Solution, intravenous, monthly, short-term = 24 weeks (6 months)
Placebo
Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior failure (inefficacy or intolerance) of therapy with disease-modifying antirheumatic drugs; if patient had prior failure of methotrexate, he or she must have been taking at least 15 mg per week for at least 2 months
* If recent failure(inefficacy or intolerance) of a tumor necrosis factor α-blockade compound, participant must be washed out prior to first dose: 56 days for infliximab and 28 days for etanercept and adalimumab
* Disease activity as defined by a tender joint count of ≥3, swollen joint count of ≥3, and clinically detectable synovitis at screening and Day 01 (prior to infusion)
* Active psoriasis with a qualifying target lesion ≥2 cm in diameter
* Able to undergo magnetic resonance imaging
* Use of appropriate birth control by women of child bearing potential (WOCBP)
Exclusion Criteria
* Women who are pregnant or breastfeeding or who plan to become pregnant or to start breastfeeding during the duration of the study
* Women with a positive pregnancy test on enrollment or prior to investigational product administration.
* Participants scheduled for or anticipating joint replacement surgery.
* Those with a recent history of clinically significant drug or alcohol abuse
* Concomitant illness that in the investigator's opinion is likely to require systemic glucocorticosteroid therapy during the study (for example: moderate to severe asthma)
* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, pulmonary, cardiac, neurologic, ophthalmologic, or cerebral disease.
* Unwillingness or inability to undergo screening based on current local or country guidelines/standards to evaluate the presence of cancer
* Cancer within the last 5 years
* Current malignancy or signs of possible malignancy detected by screening procedures for which the workup to exclude malignancy has not been completed or malignancy cannot be excluded
* At risk for or history (within 3 years) of tuberculosis
* Any serious bacterial infection within the last 3 months, not treated and resolved with antibiotics, or any chronic bacterial infection (such as, but not limited to, chronic pyelonephritis, osteomyelitis, and bronchiectasis)
* Evidence of active or latent bacterial or viral infection infections at the time of potential enrollment
* Herpes zoster or cytomegalovirus resolving less than 2 months prior to signing informed consent
* Receipt of any live vaccines within 3 months of the anticipated first dose of study medication or anticipation of the need for a live vaccine at any time during and for 3 months after the duration of the study
Long-term period participants: Must have met eligibility criteria for short-term period and completed short-term (24-week) period of the study
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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Rheumatology Associates Of North Alabama
Huntsville, Alabama, United States
Desert Medical Advances
Palm Desert, California, United States
Stanford University School Of Medicine
Palo Alto, California, United States
Boling Clinical Trials
Upland, California, United States
Joao Nascimento
Bridgeport, Connecticut, United States
New England Research Associates, Llc
Trumbull, Connecticut, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Justus Fiechtner, Md, Mph
Lansing, Michigan, United States
St. Paul Rheumatology P.A.
Eagan, Minnesota, United States
Midwest Arthritis Center
Kalamazoo, Minnesota, United States
Arthritis Clinic & Carolina Bone & Joint, Pa
Charlotte, North Carolina, United States
Deaconess Hospital
Cincinnati, Ohio, United States
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania, United States
Chase, Walter F.
Austin, Texas, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Arthritis Northwest
Spokane, Washington, United States
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Rosario, Santa Fe Province, Argentina
Local Institution
Santa Fe, Santa Fe Province, Argentina
Local Institution
Cairns, Queensland, Australia
Local Institution
Maroochydore, Queensland, Australia
Local Institution
Fitzroy, Melbourne, Victoria, Australia
Local Institution
Hasselt, , Belgium
Local Institution
Leuven, , Belgium
Local Institution
St. John's, Newfoundland and Labrador, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Québec, Quebec, Canada
Local Institution
Trois-Rivières, Quebec, Canada
Local Institution
Chambray-lès-Tours, , France
Local Institution
Lille, , France
Local Institution
Montpellier, , France
Local Institution
Frankfurt am Main, , Germany
Local Institution
Hamburg, , Germany
Local Institution
Hildesheim, , Germany
Local Institution
Napoli, , Italy
Local Institution
Potenza, , Italy
Local Institution
Reggio Emilia, , Italy
Local Institution
Amsterdam, , Netherlands
Local Institution
Lillehammer, , Norway
Local Institution
Panorama, Western Cape, South Africa
Local Institution
A Coruña, , Spain
Countries
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References
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Ostergaard M, Bird P, Pachai C, Du S, Wu C, Landis J, Fuerst T, Ahmad HA, Connolly SE, Conaghan PG. Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a randomized phase IIb study of abatacept in psoriatic arthritis. Rheumatology (Oxford). 2022 Nov 2;61(11):4305-4313. doi: 10.1093/rheumatology/keac073.
Mease P, Genovese MC, Gladstein G, Kivitz AJ, Ritchlin C, Tak PP, Wollenhaupt J, Bahary O, Becker JC, Kelly S, Sigal L, Teng J, Gladman D. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis Rheum. 2011 Apr;63(4):939-48. doi: 10.1002/art.30176.
Other Identifiers
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EUDRACT 2007-004241-15
Identifier Type: -
Identifier Source: secondary_id
IM101-158
Identifier Type: -
Identifier Source: org_study_id