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Study Complete
Sponsor ID
CC-10004-PSA-003

PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic ArthritisPALACE2

Sponsor ID
CC-10004-PSA-003
Clinicaltrials.gov ID
NCT01212757
EUCTIS ID
N/A
EudraCT ID
2010-018386-32
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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.

Apremilast is proposed to improve 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
488
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
Hospital General Carlos Haya
Málaga, Spain, 29009
Status
Completed
Location
Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Status
Completed
Location
Mayo Clinic
Rochester, Minnesota, United States, 55905
Status
Completed
Location
National Taiwan University Hospital
Tapei, Taiwan, 10002
Status
Completed
Location
UZ Leuven
Leuven, Belgium, 3000
Status
Completed
Location
Seattle Rheumatology Associates
Seattle, Washington, United States, 98104
Status
Completed
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Study Info
Age
18+ years
Condition
  • Psoriatic Arthritis
    • Sex
    All
    Trial Dates
    Sep 2010 - Jul 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) 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 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