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Study Complete
Sponsor ID
CC-10004-PSA-002

Efficacy and Safety Study of Apremilast to Treat Active Psoriatic ArthritisPALACE-1

Sponsor ID
CC-10004-PSA-002
Clinicaltrials.gov ID
NCT01172938
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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 arthritis (tender and swollen joints, pain, physical function) in treated patients.

Additional Study Details

Phase
Phase 3
Product
Otezla
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
504
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Stanford University Medical Center
Palo Alto, California, United States, 94304-1808
Status
Completed
Location
North Shore Hospital
Takapuna, New Zealand, 1309
Status
Completed
Location
Hospital Universitario La Paz
Madrid, Spain, 28046
Status
Completed
Location
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain, 15706
Status
Completed
Location
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Status
Completed
Location
Centre de Rhumatologie St-Louis
Sainte Foy, Quebec, Canada, G1W 4R4
Status
Completed
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Study Info
Age
18+ years
Condition
  • Psoriatic Arthritis
    • Sex
    All
    Trial Dates
    Jun 2010 - Apr 2012
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • 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 Criteria:
    • 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