Clinical trial NCT03747939: Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
Official title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either NSAIDS and/or ≤ 1 Conventional Synthetic DMARD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Psoriatic
Keywords: Oligoarthritis
PsA
Apremilast
Oral tablet
Background therapy
Standard of care
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2018-11-20
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration. In previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical function. This study will compare the effects of apremilast to placebo on psoriatic arthritis subjects in which the number of affected joints is limited (greater than 1 but less or equal to 4). About 285 patients worldwide will take part in this study.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 yrs, male or female subject
* Subjects must have signs and symptoms of PsA ≤5 years duration at the time of the Screening Visit
* SJC AND TJC must be \>1 and ≤ 4
* For all regions, the local Regulatory Label for treatment with apremilast must be followed.
* Stable doses of protocol-allowed PsA medications
* General good health (except for psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories. (Note: The definition of good health means a subject does not have uncontrolled significant comorbid conditions).
* Comply with protocol-required contraception measures
* Subject meets the Classification Criteria for Psoriatic Arthritis \[CASPAR\] Criteria for PsA at the Screening visit

Exclusion Criteria:

* Prior use of \>2 csDMARD to treat PsA
* Prior exposure to a JAK-inhibitor and/or a biologic DMARD.
* Use of intra-articular (IA) or intra-muscular (IM) glucocorticoid injection within 8 weeks before the Baseline Visit.
* Use of leflunomide within 12 weeks of randomization. Subjects who stopped leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x daily) prior to the Baseline Visit may enter the study.
* Prior use of cyclosporine.
* Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
* Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

Primary outcomes:
measure: Percentage of Participants Who Achieved a Clinical State of Minimal Disease Activity (MDA-Joints) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved Remission or Low Disease Activity at Week 16 Based on Clinical Activity in Psoriatic Arthritis (cDAPSA)
timeFrame: Week 16
measure: Percentage of Participants With SJC ≤ 1 at Week 16
timeFrame: Week 16
measure: Percentage of Participants With TJC ≤ 1 at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Patient's Global Assessments of Disease Activity Score of ≤ 20 mm in the VAS at Week 16
timeFrame: Week 16
measure: Percentage of Participants With an Assessment of Pain Score ≤ 15 mm in VAS at Week 16
timeFrame: Week 16
measure: Change From Baseline in Psoriatic Arthritis Impact of Disease 12-item for Clinical Trials (PsAID-12) Questionnaire Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With a Good or Moderate Psoriatic Arthritis Disease Activity (PASDAS) Score at Week 16
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Arthritis and Rheumatology Research, PLLC
state: Arizona
city: Covina
country: United States
facility: Covina Arthritis Clinic
state: California
city: Encino
country: United States
facility: Encino Research Center
state: California
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: San Diego
country: United States
facility: Rheumatology Center of San Diego PC
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials
state: California
city: Tustin
country: United States
facility: Robin K Dore MD Inc
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials Inc
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic PC
state: Colorado
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc
state: Florida
city: Fort Lauderdale
country: United States
facility: Center for Rheumatology, Immunology, and Arthritis
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology and Immunology Specialists
state: Florida
city: Saint Augustine
country: United States
facility: Florida Center For Dermatology
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida Inc
state: Florida
city: Tampa
country: United States
facility: Carol and Frank Morsani Center for Advanced Health Care
state: Florida
city: Tampa
country: United States
facility: Baycare Medical Group Inc
state: Florida
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology Group PC
state: Georgia
city: Hinsdale
country: United States
facility: RC Rsearch Inc
state: Illinois
city: Rockford
country: United States
facility: OrthoIllinois
state: Illinois
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Metairie
country: United States
facility: Clinical Trials Management LLC
state: Louisiana
city: Cumberland
country: United States
facility: Klein and Associates MD, PA - Cumberland
state: Maryland
city: Hagerstown
country: United States
facility: Klein and Associates MD PA
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Lansing
country: United States
facility: Advanced Rheumatology PC
state: Michigan
city: Lansing
country: United States
facility: Arthritis and Rheumatology Center of Michigan
state: Michigan
city: Saint Clair Shores
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Eagan
country: United States
facility: Saint Paul Rheumatology PA
state: Minnesota
city: Voorhees
country: United States
facility: Arthritis, Rheumatic, and Back Disease Associates
state: New Jersey
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research and Consulting LLC
state: Ohio
city: Middletown
country: United States
facility: Arthritis and Osteoporosis Center of Southwest Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arthritis Group
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Piedmont Arthritis Clinic
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute, llc
state: Tennessee
city: Baytown
country: United States
facility: Accurate Clinical Research Incorporated Baytown
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: El Paso
country: United States
facility: Texas Arthritis Center PA
state: Texas
city: Lubbock
country: United States
facility: West Texas Clinical Research
state: Texas
city: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia Research Institute
state: West Virginia
city: South Charleston
country: United States
facility: West Virginia Research Institute
state: West Virginia
city: Vienna
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I
city: Vienna
country: Austria
facility: Krankenhaus Hietzing
city: Bruxelles
country: Belgium
facility: Centre Hospitalier Universitaire Brugmann
city: Bruxelles
country: Belgium
facility: Hopital Erasme
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Merksem
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Jan Palfijn
city: Winnipeg
country: Canada
facility: Manitoba Clinic
state: Manitoba
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Windsor
country: Canada
facility: Dr Sabeen Anwar Medicine Professional Corporation
state: Ontario
city: Montreal
country: Canada
facility: Institut de Rhumatologie de Montreal
state: Quebec
city: Orleans cedex 2
country: France
facility: Centre Hospitalier Regional dOrleans
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Assistance Publique- Hopitaux de Paris AP-HP
city: Toulouse cedex 9
country: France
facility: CH Toulouse Hopital Pierre-Paul Riquet
city: Amberg
country: Germany
facility: Praxis fur Rheumatologie - Amberg
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin, Campus Mitte
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Erfurt
country: Germany
facility: Service Rheuma Erfurt
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Bari
country: Italy
facility: AO Ospedale Policlinico Consorziale Di Bari
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
city: Messina
country: Italy
facility: Universita degli studi Messina
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Pavia 2
country: Italy
facility: Policlinico San Matteo Universita Di Pavia
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Rome
country: Italy
facility: Fondazione Policlinico Tor Vergata
city: Rozzano MI
country: Italy
facility: Humanitas Research Hospital Humanitas Mirasole
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Kursk
country: Russian Federation
facility: Kursk Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Research Institute of Rheumatology named after V A Nasonova
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Institute n a Vladimirsky
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Clinical and Experimental Lymphology
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital na VA Baranov
city: Rostov-on-don
country: Russian Federation
facility: Municipal Budgetary Healthcare Institution City Emergency Hospital
city: Saint Petersburg
country: Russian Federation
facility: Medical Center Sanavita
city: Saint-Petersburg
country: Russian Federation
facility: Mechnikov North-Western State Medical University
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Clinical Hospital
city: Baracaldo
country: Spain
facility: Hospital Universitario de Cruces
state: País Vasco
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
city: Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Merida
country: Spain
facility: Hospital de Merida
city: Derby
country: United Kingdom
facility: Royal Berkshire Hospital
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
city: Edinburgh Scotland
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Luton
country: United Kingdom
facility: Luton and Dunstable University Hosptial
city: Torquay South Devon
country: United Kingdom
facility: Torbay Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals Trust
city: Wolverhampton
country: United Kingdom
facility: Wolverhampton Road
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Gossec L, Coates LC, Gladman DD, Aelion JA, Vasandani J, Pinter A, Merola JF, Kavanaugh A, Reddy J, Wang R, Brunori M, Klyachkin Y, Deignan C, Mease PJ. Treatment of early oligoarticular psoriatic arthritis with apremilast: primary outcomes at week 16 from the FOREMOST randomised controlled trial. Ann Rheum Dis. 2024 Oct 21;83(11):1480-1488. doi: 10.1136/ard-2024-225833.