Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriatic Arthritis
Intervention: Abatacept (Drug); Placebo (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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 InterestShort-term Period: Number of Participants With ACR 20 Response at Day 169
Secondary outcome: Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729 Short-term Period: Number of Participants With Marked Abnormalities in Hematology Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169 Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169 Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C) Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169 Short-term Period: Mean Serum Concentrations of Abatacept Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169 Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Key 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)
Key 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
- 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
Locations and Contacts
Local Institution, Santa Fe 3000, Argentina
Local Institution, Hasselt 3500, Belgium
Local Institution, Leuven 3000, Belgium
Local Institution, Quebec G1W 4R4, Canada
Local Institution, Chambray Les Tours 37170, France
Local Institution, Lille 59037, France
Local Institution, Montpellier Cedex 5 34295, France
Local Institution, Frankfurt/Main 60590, Germany
Local Institution, Hamburg 22081, Germany
Local Institution, Hildesheim 31134, Germany
Local Institution, Napoli 80131, Italy
Local Institution, Potenza 85100, Italy
Local Institution, Reggio Emilia 42100, Italy
Local Institution, Amsterdam 1105 AZ, Netherlands
Local Institution, Lillehammer 2609, Norway
Local Institution, A Coruna 15006, Spain
Rheumatology Associates Of North Alabama, Huntsville, Alabama 35801, United States
Local Institution, Capital Federal, Buenos Aires 1015, Argentina
Desert Medical Advances, Palm Desert, California 92260, United States
Stanford University School Of Medicine, Palo Alto, California 94304, United States
Boling Clinical Trials, Upland, California 91786, United States
Joao Nascimento, Bridgeport, Connecticut 06606, United States
New England Research Associates, Llc, Trumbull, Connecticut 06611, United States
Sarasota Arthritis Research Center, Sarasota, Florida 34239, United States
Clinical Pharmacology Study Group, Worcester, Massachusetts 01610, United States
Justus Fiechtner, Md, Mph, Lansing, Michigan 48910, United States
St. Paul Rheumatology P.A., Eagan, Minnesota 55121, United States
Midwest Arthritis Center, Kalamazoo, Minnesota 49048, United States
Local Institution, St. John'S, Newfoundland and Labrador A1B 3E1, Canada
Arthritis Clinic & Carolina Bone & Joint, Pa, Charlotte, North Carolina 28210, United States
Deaconess Hospital, Cincinnati, Ohio 45219, United States
Health Research Of Oklahoma, Oklahoma City, Oklahoma 73103, United States
Altoona Center For Clinical Research, Duncansville, Pennsylvania 16635, United States
Rheumatic Disease Associates, Ltd., Willow Grove, Pennsylvania 19090, United States
Local Institution, Montreal, Quebec H2L 1S6, Canada
Local Institution, Trois-Rivieres, Quebec G8Z 1Y2, Canada
Local Institution, Cairns, Queensland 4872, Australia
Local Institution, Maroochydore, Queensland 4558, Australia
Local Institution, Rosario, Santa Fe 2000, Argentina
Chase, Walter F., Austin, Texas 78705, United States
Local Institution, Fitzroy, Melbourne, Victoria 3065, Australia
Seattle Rheumatology Associates, Seattle, Washington 98104, United States
Arthritis Northwest, Spokane, Washington 99204, United States
Local Institution, Panorama, Western Cape 7500, South Africa
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: November 2007
Last updated: July 25, 2012
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