Clinical trial NCT00534313: Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-09-24
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: 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
timeFrame: From Day 169 to Day 729
measure: Short-term Period: Number of Participants With ACR 20 Response at Day 169
timeFrame: At Day 169 from Baseline
Secondary outcomes:
measure: Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729
timeFrame: At Days 365 and 729 from Baseline
measure: Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729
timeFrame: From Day 169 to Days 365 and 729
measure: Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729
timeFrame: From Baseline to Days 365 and 729
measure: 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
timeFrame: At Days 365 and 729 from baseline
measure: 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
timeFrame: Days 365 and 729 from baseline
measure: Short-term Period: Number of Participants With Marked Abnormalities in Hematology
timeFrame: From Baseline to Day 169
measure: Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)
timeFrame: From Baseline to Day 169
measure: Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry
timeFrame: Baseline to Day 169
measure: Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
timeFrame: Baseline to Day 169
measure: Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
timeFrame: From Baseline to Day 169
measure: Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis
timeFrame: From Baseline to Day 169
measure: 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
timeFrame: From Baseline to Day 169
measure: Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169
timeFrame: At Day 169 from Baseline
measure: Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169
timeFrame: At Day 169 from Baseline
measure: Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)
timeFrame: From Baseline to Day 169
measure: Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169
timeFrame: At Day 169 from Baseline
measure: Short-term Period: Mean Serum Concentrations of Abatacept
timeFrame: Days 1, 15, 29, 57, 85, 113, 141, and 169
measure: Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept
timeFrame: Days 1, 15, 29, 57, 85, 113, 141, and 169
measure: Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters
timeFrame: Days 1, 15, 29, 57, 85, 113, 141, and 169
measure: Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169
timeFrame: At Day 169 from Baseline
measure: Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169
timeFrame: At Day 169 from Baseline
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates Of North Alabama
state: Alabama
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Palo Alto
country: United States
facility: Stanford University School Of Medicine
state: California
city: Upland
country: United States
facility: Boling Clinical Trials
state: California
city: Bridgeport
country: United States
facility: Joao Nascimento
state: Connecticut
city: Trumbull
country: United States
facility: New England Research Associates, Llc
state: Connecticut
city: Sarasota
country: United States
facility: Sarasota Arthritis Research Center
state: Florida
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Lansing
country: United States
facility: Justus Fiechtner, Md, Mph
state: Michigan
city: Eagan
country: United States
facility: St. Paul Rheumatology P.A.
state: Minnesota
city: Kalamazoo
country: United States
facility: Midwest Arthritis Center
state: Minnesota
city: Charlotte
country: United States
facility: Arthritis Clinic & Carolina Bone & Joint, Pa
state: North Carolina
city: Cincinnati
country: United States
facility: Deaconess Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research Of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Willow Grove
country: United States
facility: Rheumatic Disease Associates, Ltd.
state: Pennsylvania
city: Austin
country: United States
facility: Chase, Walter F.
state: Texas
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Santa Fe
country: Argentina
facility: Local Institution
city: Cairns
country: Australia
facility: Local Institution
state: Queensland
city: Maroochydore
country: Australia
facility: Local Institution
state: Queensland
city: Fitzroy, Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Hasselt
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: St. John'S
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Local Institution
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
city: Chambray Les Tours
country: France
facility: Local Institution
city: Lille
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Frankfurt/Main
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hildesheim
country: Germany
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Potenza
country: Italy
facility: Local Institution
city: Reggio Emilia
country: Italy
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Lillehammer
country: Norway
facility: Local Institution
city: Panorama
country: South Africa
facility: Local Institution
state: Western Cape
city: A Coruna
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.