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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Psoriatic Arthritis

Thank you

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 BirminghamBirmingham, Alabama  35294-3300
Clinical Pharmacology Study GroupsWorcester, Massachusetts  01610
Center For Clinical StudiesHouston, Texas  77030
Dermatology AssociatesLos Angeles, California  90045
Desert Medical AdvancesPalm Desert, California  92260
Catalina Pointe Clinical Research IncorporatedTucson, Arizona  85704
Joao Nascimento, MDBridgeport, Connecticut  06606
In Vivo Clinical ResearchDoral, Florida  33166
Suncoast Clinical ResearchNew Port Richey, Florida  34652
Advent Clinical ResearchPinellas Park, Florida  33781
Rockford Orthopedic Associates, LTDRockford, Illinois  61107
Derm Research, LLCLouisville, Kentucky  40217
STAT ResearchDayton, Ohio  45417
West Tennessee Research InstituteJackson, Tennessee  38305
Austin Regional ClinicAustin, Texas  78731
The Clinical Research Institute of Houston, LLCHouston, Texas  77090