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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00534313
• Date of registration: 20/09/2007
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
• Scientific 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
• Date of first enrolment: November 2007
• Target sample size: 191
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00534313
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Russian Federation, South Africa, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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 a-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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis

Intervention(s)

Drug: Abatacept

Drug: Placebo

Primary Outcome(s)

Short-term Period: Number of Participants With ACR 20 Response at Day 169 [Time Frame: At Day 169 from Baseline]

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 [Time Frame: From Day 169 to Day 729]

Secondary Outcome(s)

Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept [Time Frame: Days 1, 15, 29, 57, 85, 113, 141, and 169]

Short-term Period: Number of Participants With Marked Abnormalities in Hematology [Time Frame: From Baseline to Day 169]

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 [Time Frame: At Days 365 and 729 from baseline]

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 [Time Frame: Days 365 and 729 from baseline]

Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169 [Time Frame: At Day 169 from Baseline]

Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169 [Time Frame: At Day 169 from Baseline]

Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry [Time Frame: Baseline to Day 169]

Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 [Time Frame: From Day 169 to Days 365 and 729]

Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters [Time Frame: Days 1, 15, 29, 57, 85, 113, 141, and 169]

Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169 [Time Frame: At Day 169 from Baseline]

Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169 [Time Frame: At Day 169 from Baseline]

Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 [Time Frame: From Baseline to Days 365 and 729]

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 [Time Frame: At Days 365 and 729 from Baseline]

Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) [Time Frame: From Baseline to Day 169]

Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C) [Time Frame: From Baseline to Day 169]

Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169 [Time Frame: At Day 169 from Baseline]

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 [Time Frame: From Baseline to Day 169]

Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) [Time Frame: Baseline to Day 169]

Short-term Period: Mean Serum Concentrations of Abatacept [Time Frame: Days 1, 15, 29, 57, 85, 113, 141, and 169]

Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) [Time Frame: From Baseline to Day 169]

Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis [Time Frame: From Baseline to Day 169]

Secondary ID(s)

EUDRACT 2007-004241-15

IM101-158

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/11/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00534313