Status:
COMPLETED
PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
Lead Sponsor:
Amgen
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis. Apremilast is proposed to improve signs and symptoms of psori...
Detailed Description
Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, ...
Eligibility Criteria
Inclusion
- Males or females, aged ≥ 18 years at time of consent.
- Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration.
- Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) PsA at time of screening.
- Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
- May not have axial involvement alone
- Concurrent Treatment allowed with methotrexate, leflunomide, or sulfasalazine
- Have ≥ 3 swollen AND ≥ 3 tender joints.
- Males \& Females must use contraception
- Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose oral corticosteroids allowed.
Exclusion
- Pregnant or breast feeding.
- History of allergy to any component of the investigational product.
- Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.
- Therapeutic failure on \> 3 agents for PsA or \> 1 biologic tumor necrosis factor (TNF) blocker
Key Trial Info
Start Date :
September 27 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2017
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT01212757
Start Date
September 27 2010
End Date
January 25 2017
Last Update
May 6 2020
Active Locations (98)
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1
Clinical and Translational Research Center of Alabama, PC
Tuscaloosa, Alabama, United States, 35406
2
Denver Arthritis Clinic
Denver, Colorado, United States, 80230
3
New England Research Associates, LLC
Trumbull, Connecticut, United States, 6611
4
Centre For Rheumatology, Immun. And Arthritis
Fort Lauderdale, Florida, United States, 33334