Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Last updated: June 18, 2020
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Joint Injuries

Psoriasis And Psoriatic Disorders

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT01172938
CC-10004-PSA-002
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Eligibility Criteria

Inclusion

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) at time ofscreening.

  • 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 doseoral corticosteroids allowed.

Exclusion

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

Study Design

Total Participants: 504
Study Start date:
June 02, 2010
Estimated Completion Date:
October 27, 2016

Study Description

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.

Connect with a study center

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Eastern Health Clinical School

    Box Hill, 3128
    Australia

    Site Not Available

  • Eastern Health Clinical School

    Box Hill, Vic, 3128
    Australia

    Site Not Available

  • Repatriation General Hospital

    Daws Park, 5041
    Australia

    Site Not Available

  • St Vincent's Hospital Melbourne

    Fitzroy, 3065
    Australia

    Site Not Available

  • Emeritus Research

    Malvern, 3145
    Australia

    Site Not Available

  • Medizinische Universitat Wien

    Vienna, 1090
    Austria

    Site Not Available

  • Ordination Wien Dr. Hanusch

    Vienna, 1060
    Austria

    Site Not Available

  • Kaiser-Franz-Josef Spital

    Wien, 1100
    Austria

    Site Not Available

  • Nexus Clinical Research

    St John's, Newfoundland and Labrador A1A 5E8
    Canada

    Site Not Available

  • St. Clare's Health Care Corporation of St. John's

    St John's, Newfoundland and Labrador A1C-5B8
    Canada

    Site Not Available

  • St. Clare's Health Care Corporation of St. John's

    St. John's, Newfoundland and Labrador A1C-5B8
    Canada

    Site Not Available

  • Ultranova Skincare

    Barrie, Ontario L4M 6L2
    Canada

    Site Not Available

  • MAC Research Incorporated

    Hamilton, Ontario L8N 2B6
    Canada

    Site Not Available

  • K-W Musculoskeletal Research Inc.

    Kitchener, Ontario N2M 5N6
    Canada

    Site Not Available

  • Saint Josephs Healthcare System

    London, Ontario N6A 4V2
    Canada

    Site Not Available

  • Credit Valley Professional Building

    Mississauga, Ontario L5M 2V8
    Canada

    Site Not Available

  • The Arthritis Program Research Group Inc.

    Newmarket, Ontario L3Y 3R7
    Canada

    Site Not Available

  • Toronto Western Hospital

    Toronto, Ontario M5T 258
    Canada

    Site Not Available

  • Probity Medical Research Inc

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Jude Rodrigues Private Practice

    Windsor, Ontario N8X 5A6
    Canada

    Site Not Available

  • Hospital Maisonneuve - Rosemont

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Institut de Rhumatologie de Montreal

    Montreal, Quebec H2L 1S6
    Canada

    Site Not Available

  • Centre de Rhumatologie St-Louis

    Sainte Foy, Quebec G1W 4R4
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont

    Sherbrooke, Quebec J1H5N4
    Canada

    Site Not Available

  • Saskatoon Osteoporosis Centre

    Saskatoon, Saskatchewan S7K 0H6
    Canada

    Site Not Available

  • Ipros - Chr Orleans

    Orleans, 45067
    France

    Site Not Available

  • Ipros - Chr Orleans

    Orléans, 45032
    France

    Site Not Available

  • Hopital Purpan

    Toulouse Cedex, 31009
    France

    Site Not Available

  • Klinikum Duisburg, Wedau Kliniken

    Duisburg, 47055
    Germany

    Site Not Available

  • Friedrich-Alexander-Universiät Erlangen Nürnberg

    Erlangen, 91054
    Germany

    Site Not Available

  • Allgemeines Krankenhaus Eilbeck

    Hamburg, 22081
    Germany

    Site Not Available

  • Rheumazentrum Ruhrgebiet

    Herne, 44652
    Germany

    Site Not Available

  • Praxis Prof. Herbert Kellner

    München, 80639
    Germany

    Site Not Available

  • Honvéd Kórház - Állami Egészségügyi Központ

    Budapest, 1062
    Hungary

    Site Not Available

  • Qualiclinic kft

    Budapest, 1036
    Hungary

    Site Not Available

  • Synexus Magyarország Kft.

    Budapest, 1036
    Hungary

    Site Not Available

  • MAV Korhaz es Rendelointezet Szolnok

    Szolnok, 5000
    Hungary

    Site Not Available

  • Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet

    Veszprém, 8200
    Hungary

    Site Not Available

  • P3 Research

    Crofton Downs, 6035
    New Zealand

    Site Not Available

  • Waikato hospital

    Hamilton, 3204
    New Zealand

    Site Not Available

  • Middlemore Clinical Trials

    New Zealand, 1640
    New Zealand

    Site Not Available

  • Middlemore Hospital

    Otahuhu, 1640
    New Zealand

    Site Not Available

  • Queen Elizabeth Hospital for Rheumatic Disease

    Rotorua, 3201
    New Zealand

    Site Not Available

  • North Shore Hospital

    Takapuna, 1309
    New Zealand

    Site Not Available

  • Timaru Hospital

    Timaru, 8601
    New Zealand

    Site Not Available

  • Szpital Uniwersytecki im. Dr A.Jurasza

    Bydgoszcz, 85-096
    Poland

    Site Not Available

  • Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Synexus SCM Sp. z o.o.

    Gdynia, 81-384
    Poland

    Site Not Available

  • Synexus SCM Sp. z o.o.

    Katowice, Poland
    Poland

    Site Not Available

  • Wojewodzki Zespol Reumatologiczny

    Sopot, 81-759
    Poland

    Site Not Available

  • Synexus SCM Sp. z o.o. Oddz. Warszawa

    Warszawa, 01-192
    Poland

    Site Not Available

  • Kemerovo State Medical Academy

    Kemerovo, 650066
    Russian Federation

    Site Not Available

  • Ryazan I.P. Pavlov State Medical University

    Ryazan, 390026
    Russian Federation

    Site Not Available

  • Departmental Hospital at Smolensk Station RZhD JSC

    Smolensk, 214025
    Russian Federation

    Site Not Available

  • Regional Clinical Hospital

    Vladimir, 600023
    Russian Federation

    Site Not Available

  • Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy

    Voronezh, 394066
    Russian Federation

    Site Not Available

  • Groote Schuur Hospital

    Cape Town, 7925
    South Africa

    Site Not Available

  • Panorama Medical Centre

    Cape Town, 7500
    South Africa

    Site Not Available

  • Chelmsford Medical Centre 2

    Durban, 4001
    South Africa

    Site Not Available

  • Clinresco Centres Pty Ltd

    Johannesburg, 1619
    South Africa

    Site Not Available

  • Clinresco Centres (Pty) Ltd

    Kempton Park, 1619
    South Africa

    Site Not Available

  • The Park

    Pinelands, 7700
    South Africa

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Barnsley Hospital

    Barnsley, S75 2EP
    United Kingdom

    Site Not Available

  • Barnsley Hospital

    Barnsley South Yorkshire, S75 2EP
    United Kingdom

    Site Not Available

  • West Suffolk Hospital

    Bury St Edmunds, IP33 2QZ
    United Kingdom

    Site Not Available

  • Colchester General Hospital

    Colchester, CO4 5JL
    United Kingdom

    Site Not Available

  • West Suffolk Hospital

    Edmunds, IP33 2QZ
    United Kingdom

    Site Not Available

  • Achieve Clinical Research LLC

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Arizona Research Center

    Phoenix, Arizona 85023
    United States

    Site Not Available

  • UCSD-Thornton Hospital

    La Jolla, California 92093-0943
    United States

    Site Not Available

  • Stanford University Medical Center

    Palo Alto, California 94304-1808
    United States

    Site Not Available

  • Inland Rheumatology Clinical Trials

    Upland, California 91786
    United States

    Site Not Available

  • Arthritis and Rheumatic Disease Specialties

    Aventura, Florida 33180
    United States

    Site Not Available

  • North Florida Dermatology

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Tampa Medical Group Pa

    Tampa, Florida 33614
    United States

    Site Not Available

  • Sonora Clinical Research, LLC

    Boise, Idaho 83702
    United States

    Site Not Available

  • Coeur D'Alene Arthritis Clinic

    Coeur d'Alene, Idaho 83814
    United States

    Site Not Available

  • The Arthritis Center

    Springfield, Illinois 62704
    United States

    Site Not Available

  • St. Francis Hospital and Health Centers

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Justus Fiechtner MD PC

    Lansing, Michigan 48910
    United States

    Site Not Available

  • Carolina Bone and Joint

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Physicians East

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Carolina Bone and Joint

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Piedmont Medical Research Associates Inc

    Winston-Salem, North Carolina 27103-3914
    United States

    Site Not Available

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Clinical Research Center of Reading, LLP

    West Reading, Pennsylvania 19610
    United States

    Site Not Available

  • Clinical Research Center of Reading, LLP

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Dermatology Treatment and Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • Accurate Clinical Research Inc

    Houston, Texas 77034
    United States

    Site Not Available

  • Arthritis and Osteoporosis Associates LLP

    Lubbock, Texas 79424
    United States

    Site Not Available

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Site Not Available

  • University of Utah

    Salt Lake, Utah 84132
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Seattle Rheumatology Associates

    Seattle, Washington 98104
    United States

    Site Not Available

  • Arthritis Northwest Rheumatology

    Spokane, Washington 99204
    United States

    Site Not Available

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