PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
NCT ID: NCT01212770
Last Updated: 2020-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
505 participants
INTERVENTIONAL
2010-09-30
2017-02-09
Brief Summary
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Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Apremilast 20 mg
20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase
Apremilast 20mg
Apremilast 20 mg twice daily, orally
Apremilast 30 mg
30 mg Apremilast tablets administered twice a day for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice a day for up to 4.5 years in the active treatment / long-term safety phase orally twice daily
Apremilast 30mg
Apremilast 30 mg twice daily, orally
Placebo + 20 mg Apremilast
Placebo + 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 20 mg Apremilast twice daily at Week 16
Placebo
Placebo + 30 mg Apremilast
Placebo + 30 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 30 mg Apremilast twice daily at Week 16.
Placebo
Interventions
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Apremilast 20mg
Apremilast 20 mg twice daily, orally
Apremilast 30mg
Apremilast 30 mg twice daily, orally
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Catalina Pointe Clinical Research Incorporated
Tucson, Arizona, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Desert Medical Advances
Palm Desert, California, United States
Joao Nascimento, MD
Bridgeport, Connecticut, United States
In Vivo Clinical Research
Doral, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Rheumatology Associates of Long Island
Orlando, Florida, United States
Advent Clinical Research
Pinellas Park, Florida, United States
Rockford Orthopedic Associates, LLC
Rockford, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
DermResearch, PLLC
Louisville, Kentucky, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Duke University Medical Center
Durham, North Carolina, United States
STAT Research, Inc.
Dayton, Ohio, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Austin Dermatology Associates
Austin, Texas, United States
Austin Regional Clinic
Austin, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Houston Medical Research
Houston, Texas, United States
Texas Research Center
Sugar Land, Texas, United States
Royal Prince Alfred Hospital
Camperdown, , Australia
Skin Cancer Foundation
Carlton, , Australia
Coff's Clinical Trials
Coffs Harbour, , Australia
Heidelberg Repatriation Hospital
Heidelberg, , Australia
Menzies Centre for Population Health Research
Hobart, , Australia
Optimus Clinical Research Pty. Ltd
Kogarah, , Australia
Coastal Joint Care
Maroochydore, , Australia
The Queen Elizabeth Hospital
Woodville, , Australia
Arthritis Research Centre of Canada
Vancouver, British Columbia, Canada
PerCuro Clinical Research
Victoria, British Columbia, Canada
Manitoba Clinic
Winnipeg, Manitoba, Canada
Arthritis Centre
Winnipeg, Manitoba, Canada
Alpha Clinical Research, LLC
St. John's, Newfoundland and Labrador, Canada
Niagara Peninsula Arthritis Centre Inc.
St. Catharines, Ontario, Canada
Manna Research
Toronto, Ontario, Canada
Helsingin Reumakeskus Oy
Helsinki, , Finland
Helsingin yliopistollinen keskussairaala
Helsinki, , Finland
Finnish Medical Research Co
Pori, , Finland
Centre Hospitalier Sud Francilien - Site Gilles de Corbeil
Corbeil-Essonnes, , France
Hôtel-Dieu
Nantes, , France
Groupe Hospitalier Archet I et II
Nice, , France
Hopital Larrey Universite Paul Sabatier
Toulouse, , France
Charite - Universitätsmedizin Berlin
Berlin, , Germany
Klinische Forschung Berlin - Buch GmbH
Berlin, , Germany
Klinikum der Friedrich-Schiller-Universität Jena
Jena, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, , Italy
Fondazione PTV Policlinico Tor Vergata
Roma, , Italy
Hospital of Lithuanian University Health and Sciences
Kaunas, , Lithuania
Klaipeda University Hospital
Klaipėda, , Lithuania
Panevezys Hospital
Panevezys, , Lithuania
Siauliai Hospital
Šiauliai, , Lithuania
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, , Poland
Centrum Medyczne Silesiana Sp. z o.o.
Bytom, , Poland
Malopolskie Centrum Medyczne S.C.
Krakow, , Poland
Prywatna Praktyka Lekarska Pawel Hrycaj
Poznan, , Poland
REUMATIKA-Centrum Reumatologii Niepubliczny Zaklad Opieki Zdrowotnej
Warsaw, , Poland
Baia Mare, Emergency County Hospital "Dr. Constantin Opris"
Baia Mare, , Romania
SC Duo Medical SRL
Bucharest, , Romania
Sf. Maria Clinical Hospital
Bucharest, , Romania
Emergency County Clinical Hospital
Cluj-Napoca, , Romania
Sf Apostol Andrei Emergency Clinical County Hospital
Galati, , Romania
C.M.I. Dr. Ciornohuz Adriana
Iași, , Romania
Research Medical Complex Vashe Zdorovie
Kezch, , Russia
Research Institute of Clinical and Experimental Lymphology
Novosibirsk, , Russia
Penza Regional Clinical Hospital n.a. N.N. Burdenko
Penza, , Russia
City Hospital 26
Saint Petersburg, , Russia
Sverdlovsk Regional Clinical Hospital 1
Yekaterinburg, , Russia
Narodny ustav reumatickych chorob
Piešťany, , Slovakia
MUDr. Zuzana Cizmarikova, s.r.o.
Poprad,Spisska Sobota, , Slovakia
REUMEX s.r.o.
Rimavská Sobota, , Slovakia
Hallym University Sacred Heart Hospital
Anyang, Kyunggi, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Inha University Hosiptal
Incheon, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hospital Universitario a Coruna
A Coruña, , Spain
Hospital de Basurto-Osakidetza
Bilbao, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Infanta Sofia
San Sebastián de los Reyes, , Spain
HFR Fribourg - Hôpital Cantonal
Fribourg, , Switzerland
Chuv Bh-04
Lausanne, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Haywood Hospital
Burslem, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Edwards CJ, Blanco FJ, Crowley J, Birbara CA, Jaworski J, Aelion J, Stevens RM, Vessey A, Zhan X, Bird P. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3). Ann Rheum Dis. 2016 Jun;75(6):1065-73. doi: 10.1136/annrheumdis-2015-207963. Epub 2016 Jan 20.
Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14.
Mease PJ, Gladman DD, Kavanaugh A, McGonagle D, Nash P, Guerette B, Nakasato P, Brunori M, Teng L, McInnes IB. Articular and Extra-Articular Benefits in ACR20 Non-responders at Week 104 Treated With Apremilast: Pooled Analysis of Three Randomized Controlled Trials. Rheumatol Ther. 2021 Dec;8(4):1677-1691. doi: 10.1007/s40744-021-00369-x. Epub 2021 Sep 18.
Mease PJ, Gladman DD, Ogdie A, Coates LC, Behrens F, Kavanaugh A, McInnes I, Queiro R, Guerette B, Brunori M, Teng L, Smolen JS. Treatment-to-Target With Apremilast in Psoriatic Arthritis: The Probability of Achieving Targets and Comprehensive Control of Disease Manifestations. Arthritis Care Res (Hoboken). 2020 Jun;72(6):814-821. doi: 10.1002/acr.24134. Epub 2020 May 8.
Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.
Gladman DD, Kavanaugh A, Gomez-Reino JJ, Wollenhaupt J, Cutolo M, Schett G, Lespessailles E, Guerette B, Delev N, Teng L, Edwards CJ, Birbara CA, Mease PJ. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018.
Other Identifiers
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CC-10004-PSA-004
Identifier Type: -
Identifier Source: org_study_id
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