Status:
COMPLETED
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, specifically in improving signs and symptoms of psoriatic arth...
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) 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 :
June 2 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2016
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT01172938
Start Date
June 2 2010
End Date
October 27 2016
Last Update
June 19 2020
Active Locations (92)
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1
Achieve Clinical Research LLC
Birmingham, Alabama, United States, 35216
2
Arizona Research Center
Phoenix, Arizona, United States, 85023
3
UCSD-Thornton Hospital
La Jolla, California, United States, 92093-0943
4
Stanford University Medical Center
Palo Alto, California, United States, 94304-1808