Status:
COMPLETED
PALACE 3: 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 and a qualifying psoriasis lesion. Apremilast is proposed to i...
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) criteria for PsA at time of screening.
- Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
- May not have axial involvement alone
- Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine
- Have ≥ 3 swollen AND ≥ 3 tender joints.
- Males \& Females must use contraception
- Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed.
- Have at least one ≥2 cm psoriasis lesion
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 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2017
Estimated Enrollment :
505 Patients enrolled
Trial Details
Trial ID
NCT01212770
Start Date
September 30 2010
End Date
February 9 2017
Last Update
May 6 2020
Active Locations (91)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Elite Clinical Studies, LLC
Phoenix, Arizona, United States, 85018
3
Catalina Pointe Clinical Research Incorporated
Tucson, Arizona, United States, 85704
4
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States, 93309