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Study Complete
Sponsor ID
CC-10004-PSA-004

PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic ArthritisPALACE 3

Sponsor ID
CC-10004-PSA-004
Clinicaltrials.gov ID
NCT01212770
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 and a qualifying psoriasis lesion.

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
505
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
Contact Us
Location
Seoul National University Hospital
Seoul, Republic of Korea, 03080
Status
Completed
Location
Ajou University Hospital
Suwon, Republic of Korea, 443-721
Status
Completed
Location
The Queen Elizabeth Hospital
Woodville, Australia, 5011
Status
Completed
Location
Chungnam National University Hospital
DaeJeon, Republic of Korea, 301-721
Status
Completed
Location
Severance Hospital
Seoul, Republic of Korea, 120-752
Status
Completed
Location
Hallym University Sacred Heart Hospital
Anyang, Kyunggi, Republic of Korea, 431070
Status
Completed
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Study Info
Age
18+ years
Condition
  • Psoriatic Arthritis
    • Sex
    All
    Trial Dates
    Sep 2010 - Aug 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) 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 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