Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
- Conditions
- Arthritis, Psoriatic
- Interventions
- Other: Apremilast (CC-10004) Placebo
- Registration Number
- NCT03747939
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
- ≥ 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARD Apremilast (CC-10004) Subjects will take ORAL tables of apremilast for up to 48 weeks (30 mg twice daily). Subjects may also receive stable doses of background therapy (standard or care) with NSAIDs, glucorticosteroids and 1 csDMARD as permitted by protocol. After wk. 24, subjects may change the dose /type of permitted Psoriatic Arthritis medications Placebo Apremilast (CC-10004) Placebo Subjects will take placebo for up to 24 weeks (twice daily). Subjects may also receive stable doses of background therapy ( standard of care) with NSAIDs, glucocorticosteroids and 1 csDMARD as permitted by protocol. After wk 24, subjects may change the dose /type of permitted PsA medications.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieved a Clinical State of Minimal Disease Activity (MDA-Joints) Response at Week 16 Week 16 MDA is defined as tender joint counts (TJC) ≤ 1 and SJC ≤ 1 plus 3 of the following 5 criteria:
1. psoriasis body surface area (BSA) ≤ 3%
2. patient's pain visual analogue scale (VAS) on a 100 mm scale ≤ 15; where 0 indicates 'no pain' and 100 indicates 'pain as severe as can be imagined'
3. patient's global assessment of disease activity on a 100 mm scale ≤ 20, where 0 represents the lowest level of disease activity and 100 represents the highest.
4. physical function assessed by Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ 0.5; where 0 represents normal or no difficulty and 3 represents an inability to perform
5. enthesitis count ≤ 1 based on the Leeds Enthesitis Index; where 0 means nontender and 6 indicates 6 tender tendon insertions.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Psoriatic Arthritis Impact of Disease 12-item for Clinical Trials (PsAID-12) Questionnaire Score at Week 16 Baseline and Week 16 The PsAID-12 Questionnaire is a 12-item, self-administered questionnaire that reflects the impact of psoriatic arthritis from the perspective of the participant. The overall score ranges from 0 (best status) to 10 (worst status), with a cut-off ≤ 4 representing patient-acceptable symptom state. Analysis was based on a mixed-effects model for repeated measures (MMRM), which included treatment group, time, treatment group by time interaction, prior/concomitant use of csDMARD (naive, prior use only, both prior and concomitant use) and baseline glucocorticosteroid use (yes/no) per IWRS data as factors, and baseline value as a covariate.
Percentage of Participants With a Good or Moderate Psoriatic Arthritis Disease Activity (PASDAS) Score at Week 16 Baseline and Week 16 The PASDAS is a weighted index comprising assessments of joints, function, acute-phase response, quality of life, and patient and physician VAS. The score range of the PASDAS is 0 - 10, with worse disease activity represented by higher scores. A good response is defined as a PASDAS score of ≤ 3.2 with improvement from baseline ≥ 1.6 points. A moderate response is defined as a PASDAS score \> 3.2 with improvement from baseline ≥ 1.6 points; or PASDAS score \< 5.4 with improvement from baseline ≥ 0.8 but \< 1.6 points.
Percentage of Participants With TJC ≤ 1 at Week 16 Week 16 The TJC was based on 68 joints and at week 16 was based on the sentinel joints (i.e., the joints that were affected at baseline). A TJC response is defined as a count ≤ 1.
Percentage of Participants With Patient's Global Assessments of Disease Activity Score of ≤ 20 mm in the VAS at Week 16 Week 16 The Patient's Global Assessments of Disease Activity is an assessment of how active a participant's psoriatic arthritis was on average during the last week. It was assessed on a VAS ranging from 0 to 100 mm, with a higher score indicating more disease activity. A response is defined as a score ≤ 20 mm.
Percentage of Participants With an Assessment of Pain Score ≤ 15 mm in VAS at Week 16 Week 16 The Patients Pain VAS is the participant's assessment of how much pain they had, on average, during the last week in their joints due to psoriatic arthritis. The VAS score ranges from 0 to 100 mm, with a higher score indicating more pain.
Percentage of Participants Who Achieved Remission or Low Disease Activity at Week 16 Based on Clinical Activity in Psoriatic Arthritis (cDAPSA) Week 16 The cDAPSA score is based on the numerical summation of 4 disease activity variables: tender and swollen joints, patient's global assessments of disease activity and assessment of pain (VAS). The cDAPSA score ranges from 0 to 154, with a higher score indicating more disease activity.
cDAPSA remission is defined as a DAPSA score ≤ 4 and low disease activity is defined as a cDAPSA score \> 4 but ≤ 13).Percentage of Participants With SJC ≤ 1 at Week 16 Week 16 The SJC was based on 66 joints and at week 16 is based on the sentinel joints (i.e., the joints that were affected at baseline). A SJC response is defined as a count ≤ 1.
Trial Locations
- Locations (113)
West Tennessee Research Institute, llc
🇺🇸Jackson, Tennessee, United States
Dr Sabeen Anwar Medicine Professional Corporation
🇨🇦Windsor, Ontario, Canada
Charite - Universitaetsmedizin Berlin, Campus Mitte
🇩🇪Berlin, Germany
Research Institute of Rheumatology named after V A Nasonova
🇷🇺Moscow, Russian Federation
Moscow Regional Research Institute n a Vladimirsky
🇷🇺Moscow, Russian Federation
Arizona Arthritis and Rheumatology Research, PLLC
🇺🇸Mesa, Arizona, United States
Covina Arthritis Clinic
🇺🇸Covina, California, United States
Encino Research Center
🇺🇸Encino, California, United States
Providence Medical Foundation
🇺🇸Fullerton, California, United States
Rheumatology Center of San Diego PC
🇺🇸San Diego, California, United States
East Bay Rheumatology Medical
🇺🇸San Leandro, California, United States
Millennium Clinical Trials
🇺🇸Thousand Oaks, California, United States
Robin K Dore MD Inc
🇺🇸Tustin, California, United States
Inland Rheumatology Clinical Trials Inc
🇺🇸Upland, California, United States
Denver Arthritis Clinic PC
🇺🇸Denver, Colorado, United States
Arthritis and Rheumatic Disease Specialties
🇺🇸Aventura, Florida, United States
Clinical Research of West Florida, Inc
🇺🇸Clearwater, Florida, United States
Center for Rheumatology, Immunology, and Arthritis
🇺🇸Fort Lauderdale, Florida, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
Integral Rheumatology and Immunology Specialists
🇺🇸Plantation, Florida, United States
Florida Center For Dermatology
🇺🇸Saint Augustine, Florida, United States
Clinical Research of West Florida Inc
🇺🇸Tampa, Florida, United States
Carol and Frank Morsani Center for Advanced Health Care
🇺🇸Tampa, Florida, United States
Baycare Medical Group Inc
🇺🇸Tampa, Florida, United States
North Georgia Rheumatology Group PC
🇺🇸Lawrenceville, Georgia, United States
RC Rsearch Inc
🇺🇸Hinsdale, Illinois, United States
OrthoIllinois
🇺🇸Rockford, Illinois, United States
Graves Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
Clinical Trials Management LLC
🇺🇸Metairie, Louisiana, United States
Klein and Associates MD PA
🇺🇸Hagerstown, Maryland, United States
Klein and Associates MD, PA - Cumberland
🇺🇸Cumberland, Maryland, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
Advanced Rheumatology PC
🇺🇸Lansing, Michigan, United States
Arthritis and Rheumatology Center of Michigan
🇺🇸Lansing, Michigan, United States
Clinical Research Institute of Michigan
🇺🇸Saint Clair Shores, Michigan, United States
Saint Paul Rheumatology PA
🇺🇸Eagan, Minnesota, United States
Arthritis, Rheumatic, and Back Disease Associates
🇺🇸Voorhees, New Jersey, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
Joint and Muscle Research Institute
🇺🇸Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Paramount Medical Research and Consulting LLC
🇺🇸Middleburg Heights, Ohio, United States
Arthritis and Osteoporosis Center of Southwest Ohio
🇺🇸Middletown, Ohio, United States
Health Research of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Arthritis Group
🇺🇸Philadelphia, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Piedmont Arthritis Clinic
🇺🇸Greenville, South Carolina, United States
Accurate Clinical Research Incorporated Baytown
🇺🇸Baytown, Texas, United States
Precision Comprehensive Clinical Research Solutions
🇺🇸Colleyville, Texas, United States
Texas Arthritis Center PA
🇺🇸El Paso, Texas, United States
West Texas Clinical Research
🇺🇸Lubbock, Texas, United States
Advanced Rheumatology of Houston
🇺🇸The Woodlands, Texas, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Seattle Rheumatology Associates
🇺🇸Seattle, Washington, United States
Rheumatology and Pulmonary Clinic
🇺🇸Beckley, West Virginia, United States
West Virginia Research Institute
🇺🇸South Charleston, West Virginia, United States
Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I
🇦🇹Vienna, Austria
Krankenhaus Hietzing
🇦🇹Vienna, Austria
Centre Hospitalier Universitaire Brugmann
🇧🇪Bruxelles, Belgium
Hopital Erasme
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Ziekenhuis Netwerk Antwerpen Jan Palfijn
🇧🇪Merksem, Belgium
Manitoba Clinic
🇨🇦Winnipeg, Manitoba, Canada
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Institut de Rhumatologie de Montreal
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Regional dOrleans
🇫🇷Orleans cedex 2, France
Hopital Lariboisiere
🇫🇷Paris, France
Assistance Publique- Hopitaux de Paris AP-HP
🇫🇷Paris, France
CH Toulouse Hopital Pierre-Paul Riquet
🇫🇷Toulouse cedex 9, France
Praxis fur Rheumatologie - Amberg
🇩🇪Amberg, Germany
Kerckhoff-Klinik gGmbH
🇩🇪Bad Nauheim, Germany
Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
Service Rheuma Erfurt
🇩🇪Erfurt, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main
🇩🇪Frankfurt am Main, Germany
Universitatsklinikum Freiburg
🇩🇪Freiburg, Germany
Rheumazentrum Ruhrgebiet
🇩🇪Herne, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
AO Ospedale Policlinico Consorziale Di Bari
🇮🇹Bari, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
🇮🇹Brescia, Italy
Universita degli studi Messina
🇮🇹Messina, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Policlinico San Matteo Universita Di Pavia
🇮🇹Pavia 2, Italy
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Italy
Fondazione Policlinico Tor Vergata
🇮🇹Rome, Italy
Humanitas Research Hospital Humanitas Mirasole
🇮🇹Rozzano MI, Italy
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
🇮🇹Verona, Italy
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Kazan State Medical University
🇷🇺Kazan, Russian Federation
Kursk Regional Clinical Hospital
🇷🇺Kursk, Russian Federation
Research Institute of Clinical and Experimental Lymphology
🇷🇺Novosibirsk, Russian Federation
Republican Hospital na VA Baranov
🇷🇺Petrozavodsk, Russian Federation
Municipal Budgetary Healthcare Institution City Emergency Hospital
🇷🇺Rostov-on-don, Russian Federation
Medical Center Sanavita
🇷🇺Saint Petersburg, Russian Federation
Mechnikov North-Western State Medical University
🇷🇺Saint-Petersburg, Russian Federation
Tomsk Regional Clinical Hospital
🇷🇺Tomsk, Russian Federation
Hospital Universitario de Cruces
🇪🇸Baracaldo, País Vasco, Spain
Hospital Galdakao-Usansolo
🇪🇸Galdakao, Spain
Hospital Universitario Insular de Gran Canaria
🇪🇸Gran Canaria, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital de Merida
🇪🇸Merida, Spain
Royal Berkshire Hospital
🇬🇧Derby, United Kingdom
Eastbourne District General Hospital
🇬🇧Eastbourne, United Kingdom
Western General Hospital
🇬🇧Edinburgh Scotland, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Luton and Dunstable University Hosptial
🇬🇧Luton, United Kingdom
Torbay Hospital
🇬🇧Torquay South Devon, United Kingdom
Royal Cornwall Hospitals Trust
🇬🇧Truro, United Kingdom
Wolverhampton Road
🇬🇧Wolverhampton, United Kingdom