PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
NCT ID: NCT01212757
Last Updated: 2020-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
488 participants
INTERVENTIONAL
2010-09-27
2017-01-25
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 20mg
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 30mg
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 + 20 mg Apremilast
Placebo + 20 mg Apremilast
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 + 30 mg Apremilast
Placebo + 30 mg Apremilast
Interventions
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Apremilast 20mg
Apremilast 20 mg twice daily, orally
Apremilast 30mg
Apremilast 30 mg twice daily, orally
Placebo + 20 mg Apremilast
Placebo + 20 mg Apremilast
Placebo + 30 mg Apremilast
Placebo + 30 mg Apremilast
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) PsA at time of screening.
* 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 dose oral corticosteroids allowed.
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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Clinical and Translational Research Center of Alabama, PC
Tuscaloosa, Alabama, United States
Denver Arthritis Clinic
Denver, Colorado, United States
New England Research Associates, LLC
Trumbull, Connecticut, United States
Centre For Rheumatology, Immun. And Arthritis
Fort Lauderdale, Florida, United States
DMI Research
St. Petersburg, Florida, United States
University of South Florida
Tampa, Florida, United States
Arthritis and Rheumatology of Georgia
Atlanta, Georgia, United States
Michael Bukhalo MD SC
Arlington Hts, Illinois, United States
Associated Internal Medical Specialist, PC
Battle Creek, Michigan, United States
Advanced Rheumatology
Lansing, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Research West Incorporated
Kalispell, Montana, United States
University of Rochester Medical Center
Rochester, New York, United States
Vital Research
Greensboro, North Carolina, United States
Unifour Medical Research Associatets LLC
Hickory, North Carolina, United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Baylor Research Institute
Dallas, Texas, United States
Arthritis Care and Diagnostic Center
Dallas, Texas, United States
Luckster Enterprises
San Antonio, Texas, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, United States
Rheumatology and Immunotherapy Center
Franklin, Wisconsin, United States
CHU Brugmann
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
University Hospital of Liege CHU Liege
Liège, , Belgium
Diagnostic and Consulting Centre 7
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
Sofia, , Bulgaria
17 Diagnostic and Consulting Centre Sofia EOOD
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski
Sofia, , Bulgaria
Diagnostic-Consultative Center Sveta Anna
Sofia, , Bulgaria
Diagnostic and Consulting Centre 4
Varna, , Bulgaria
Rheumatology Research Associates
Edmonton, Alberta, Canada
PerCuro Clinical Research
Victoria, British Columbia, Canada
Anna Jaroszynska Private Practice
Burlington, Ontario, Canada
William Bensen's Private Practice
Hamilton, Ontario, Canada
North Bay Dermatology Center
North Bay, Ontario, Canada
Rheumatology Research Associates
Ottawa, Ontario, Canada
Wilderman Medical Clinic
Thornhill, Ontario, Canada
Darryl Toth's Private Practice
Windsor, Ontario, Canada
Revmatologie s.r.o.
Brno, , Czechia
MEDIPONT PLUS s.r.o..
České Budějovice, , Czechia
L.K.N. Arthrocentrum s.r.o.
Hlučín, , Czechia
ARTMEDI UPD s.r.o.
Hostivice, , Czechia
Revmatologicky ustav
Prague, , Czechia
Revmatologicka Ambulance
Prague, , Czechia
Affidea Praha s.r.o
Prague, , Czechia
Revmatologicka Ambulance
Sokolov, , Czechia
PV - MEDICAL, s.r.o.
Zlín, , Czechia
Parnu Hospital
Pärnu, , Estonia
East Tallinn Central Hospital
Tallinn, , Estonia
North Estonia Regional Hospital
Tallinn, , Estonia
Clinical Research Centre Ltd
Tartu, , Estonia
Tartu University Hospital
Tartu, , Estonia
Hopital Universitaire Dupuytren
Limoges, , France
Hopital Lariboisiere
Paris, , France
Fondation Hôpital Saint-Joseph
Paris, , France
Groupe Hospitalier Pitié- Salpétrière
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Charite - Universitätsmedizin Berlin
Berlin, , Germany
Klinikum der Johann-Wolfgang Goethe-Universität
Frankfurt, , Germany
Praxis Karin Rockwitz
Goslar, , Germany
Synexus Clinical Research GmbH
Leipzig, , Germany
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, , Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, , Hungary
Principal SMO Kft.
Makó, , Hungary
Azienda Ospedaliera Universitaria San Martino
Genova, , Italy
Ospedale Luigi Sacco
Milan, , Italy
Seconda Universita degli Studi di Napoli
Napoli, , Italy
IRCCS Policlinico San Matteo
Pavia, , Italy
Universita di Pisa
Pisa, , Italy
Ospedale Civile Maggiore Borgo Trento
Verona, , Italy
NZOZ Osteo-Medic sc A. Racewicz J. Supronik
Bialystok, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej REUMED
Lublin, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher
Warsaw, , Poland
Synexus SCM Sp. z o.o.
Wroclaw, , Poland
City Clinical Hospital #1 n.a. N.I.Pirogov
Moscow, , Russia
City Clinical Hospital #5
Nizhny Novgorod, , Russia
St.Petersburg State Medical Academy n. a. I.I.Mechnikov
Saint Petersburg, , Russia
Yaroslavl Regional Clinical Hospital
Yaroslavl, , Russia
Nelson Mandela School Of Medicine
Durban, , South Africa
Greenacres Hospital
Port Elizabeth, , South Africa
Jacaranda Hospital
Pretoria, , South Africa
Hospital General Carlos Haya
Málaga, , Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, , Spain
Hospital Sierrallana
Torrelavega, , Spain
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Cathay General Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Tapei, , Taiwan
Basingstoke and North Hampshire Hospital
Basingstoke, , United Kingdom
Cannock Chase Hospital
Cannock, , United Kingdom
Chapel Allerton Hospital
Leeds, , United Kingdom
Poole Hospital
Poole, , United Kingdom
Great Western Hospital
Swindon, , United Kingdom
Countries
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References
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Cutolo M, Myerson GE, Fleischmann RM, Liote F, Diaz-Gonzalez F, Van den Bosch F, Marzo-Ortega H, Feist E, Shah K, Hu C, Stevens RM, Poder A. A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial. J Rheumatol. 2016 Sep;43(9):1724-34. doi: 10.3899/jrheum.151376. Epub 2016 Jul 15.
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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2010-018386-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-10004-PSA-003
Identifier Type: -
Identifier Source: org_study_id
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