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



Status:Completed
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:7/20/2018
Start Date:September 30, 2010
End Date:February 9, 2017

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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis and a Qualifying Psoriasis Lesion

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.

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, reflects a complex interaction among resident dendritic, fibroblastic and
endothelial cells, and inflammatory cells attracted to the synovium by cytokines and
chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory
pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore,
apremilast has the potential to be effective in the treatment of PsA.

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
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Rockford, Illinois 61107
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Austin, Texas 78731
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Austin, Texas 78705
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Bridgeport, Connecticut 06606
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Camperdown, 2050
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Dayton, Ohio 45417
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Doral, Florida 33166
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Houston, Texas 77090
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Indianapolis, Indiana 46256
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Jackson, Tennessee 38305
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Los Angeles, California 90045
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Louisville, Kentucky 40217
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New Port Richey, Florida 34652
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Palm Desert, California 92260
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Phoenix, Arizona 85018
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Pinellas Park, Florida 33781
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Sugar Land, Texas 77479
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Worcester, Massachusetts 01610
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