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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

Phase 2
18 Years
Not Enrolling
Psoriatic Arthritis

Thank you

Trial Information

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


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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome 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

Outcome Description:

Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.

Outcome Time Frame:

From Day 169 to Day 729

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

May 2011

Related Keywords:

  • Psoriatic Arthritis
  • Arthritis
  • Arthritis, Psoriatic



Stanford University School of Medicine Stanford, California  94305-5317
Altoona Center for Clinical Research Duncansville, Pennsylvania  16635
Rheumatology Associates Of North Alabama Huntsville, Alabama  35801
New England Research Associates, Llc Trumbull, Connecticut  06611
Health Research Of Oklahoma Oklahoma City, Oklahoma  73103
Desert Medical Advances Palm Desert, California  92260
Boling Clinical Trials Upland, California  91786
Clinical Pharmacology Study Group Worcester, Massachusetts  01610
Joao Nascimento Bridgeport, Connecticut  06606
Sarasota Arthritis Research Center Sarasota, Florida  34239
Justus Fiechtner, Md, Mph Lansing, Michigan  48910
St. Paul Rheumatology P.A. Eagan, Minnesota  55121
Midwest Arthritis Center Kalamazoo, Minnesota  49048
Arthritis Clinic & Carolina Bone & Joint, Pa Charlotte, North Carolina  28210
Deaconess Hospital Cincinnati, Ohio  45219
Rheumatic Disease Associates, Ltd. Willow Grove, Pennsylvania  19090
Chase, Walter F. Austin, Texas  78705
Seattle Rheumatology Associates Seattle, Washington  98104
Arthritis Northwest Spokane, Washington  99204