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Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis

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

NCT00534313•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of active arthritis due to psoriatic arthritis in patients who have had a prior inadequate response to disease-modifying antirheumatic drugs, including methotrexate and tumor necrosis factor alpha-blockade compounds.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Meeting classification criteria for psoriatic arthritis for a duration of disease of at least 3 months
•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

•WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of investigational product
•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
+6 more criteria

Locations (44)

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

Key Dates

Start Date

November 1, 2007

Primary Completion Date

December 1, 2008

Completion Date

May 1, 2011

Last Updated

August 1, 2012

Enrollment

191

ACTUAL participants

Conditions

Psoriatic Arthritis

Interventions

Abatacept

DRUG

Placebo

DRUG

A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509

Psoriatic Arthritis

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RECRUITINGPHASE3

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

NCT06100744

Juvenile Psoriatic Arthritis

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RECRUITING

Rheumatology Patient Registry and Biorepository

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis

Inclusion Criteria

Exclusion Criteria

A Study of Picankibart in Patients With Active Psoriatic Arthritis

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Rheumatology Patient Registry and Biorepository

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A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis

Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis