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
18 Years
N/A
Both
Psoriatic Arthritis
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
American College of Rheumatology 20 (ACR 20)
Outcome Description:
Proportion of subjects in each treatment group who achieve the American College of Rheumatology criteria for a 20% improvement (ACR 20), compared with baseline after 16 weeks of treatment
Outcome Time Frame:
16 weeks
Safety Issue:
No
Principal Investigator
Douglas Hough, MD
Investigator Role:
Study Director
Investigator Affiliation:
Celgene Corporation
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
CC-10004-PSA-004
NCT ID:
NCT01212770
Start Date:
September 2010
Completion Date:
November 2015
Related Keywords:
- Psoriatic Arthritis
- Psoriatic Arthritis
- Psoriasis
- Arthritis
- inflammation
- skin condition
- inflammatory cells
- apremilast
- CC-10004
- phosphodiesterase type 4
- Arthritis
- Arthritis, Psoriatic
Name | Location |
|---|---|
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Clinical Pharmacology Study Groups | Worcester, Massachusetts 01610 |
| Center For Clinical Studies | Houston, Texas 77030 |
| Dermatology Associates | Los Angeles, California 90045 |
| Desert Medical Advances | Palm Desert, California 92260 |
| Catalina Pointe Clinical Research Incorporated | Tucson, Arizona 85704 |
| Joao Nascimento, MD | Bridgeport, Connecticut 06606 |
| In Vivo Clinical Research | Doral, Florida 33166 |
| Suncoast Clinical Research | New Port Richey, Florida 34652 |
| Advent Clinical Research | Pinellas Park, Florida 33781 |
| Rockford Orthopedic Associates, LTD | Rockford, Illinois 61107 |
| Derm Research, LLC | Louisville, Kentucky 40217 |
| STAT Research | Dayton, Ohio 45417 |
| West Tennessee Research Institute | Jackson, Tennessee 38305 |
| Austin Regional Clinic | Austin, Texas 78731 |
| The Clinical Research Institute of Houston, LLC | Houston, Texas 77090 |
