A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis

NCT03783026 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: CC-10004-PSA-014U1111-1223-98232018-002748-10
• Study Type: interventional
• Target: 123
• Locations: 11 countries
• Sites: 36

Brief Summary

This study is designed to assess the efficacy of apremilast, either in monotherapy or with stable methotrexate, on imaging outcomes in adults with active psoriatic arthritis with less than 5 years of disease duration (since diagnosis), and who are naïve to biologic therapies.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; CC-10004; MRI; apremilast

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 24

  PsAMRIS is a validated MRI scoring system that assesses metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of fingers 2 to 5 of the most affected hand (the hand with the greater inflammatory burden of swollen joints and/or dactylitis). Synovitis, flexor tenosynovitis, and bone marrow edema were scored from 0 (none/normal) to 3 (severe) at each joint. The total scores for synovitis and tenosynovitis range from 0 to 36 and the total score for BME ranges from 0 to 72 since both proximal and distal regions of each joint were scored. The PsAMRIS composite inflammation score is calculated as: BME score + 2 × synovitis score + 2 × tenosynovitis score, and ranges from 0 (normal) to 216 (severe). A negative change from baseline indicates improvement. This endpoint was analyzed using a mixed-effects model for repeated measures (MMRM) with change from baseline as the dependent variable; baseline value, scanner type and time as independent variables.

  Baseline and week 24

Secondary Outcomes (30)

• Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 48

  Baseline and week 48

• Change From Baseline in the Composite Score of BME and Synovitis Assessed by PsAMRIS at Weeks 24 and 48

  Baseline and weeks 24 and 48

• Change From Baseline in the PsAMRIS Total Inflammation Score at Weeks 24 and 48

  Baseline and weeks 24 and 48

• Change From Baseline in Bone Marrow Edema Assessed by PsAMRIS at Weeks 24 and 48

  Baseline and weeks 24 and 48

• Change From Baseline in Synovitis Assessed by PsAMRIS at Weeks 24 and 48

  Baseline and weeks 24 and 48

Study Arms (1)

Apremilast

EXPERIMENTAL

Participants will receive apremilast 30 mg twice a day for 48 weeks.

Drug: Apremilast

Interventions

Apremilast DRUG

Tablets for oral administration

Also known as: CC-10004, Otezla®

Apremilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Males or females, aged ≥ 18 years at time of consent
• For all regions, the local Regulatory Label for treatment with apremilast must be followed.
• Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
• Able to adhere to the study visit schedule and other protocol requirements
• Have a documented diagnosis of PsA of ≥ 3 months AND ≤ 5 years in duration, meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) at the time of Screening Visit
• Have ≥ 3 swollen AND ≥ 3 tender joints, with hand involvement (defined as ≥ 1 swollen joint or dactylitis \[each clinically active joint of a dactylitic digit is counted as one joint\]).
• Have at least 1 active enthesitis site (one of the Spondyloarthritis Research Consortium of Canada \[SPARCC\] or Leeds Enthesitis Index \[LEI\] sites)
• Must not have been treated previously with a tumor necrosis factor (TNF) blocker or other biologic drug for PsA treatment
• Must not have been treated with more than 2 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)
• Subjects taking csDMARDs, with the exception of methotrexate (MTX), cyclosporine, or leflunomide (LEF), do not require a washout period. However, they must discontinue the csDMARD treatment at least one day prior to their Baseline Visit (ie, Visit 2, Day 1)
• Subjects who have been previously treated with MTX for \< 6 months and who are not on stable doses for at least 3 months will require a 28-day washout prior to the Baseline Visit to participate in the study
• Subjects who have been previously treated with LEF will require a 12-week washout prior to the Baseline Visit, or treatment with cholestyramine, per LEF prescribing label (ie, 8 g cholestyramine 3 times daily for 11 days)
• Subjects who have been previously treated with cyclosporine will require a 28-day washout prior to the Baseline Visit to participate in the study
• If taking MTX (≤ 25 mg/week), continuity of treatment will be allowed if duration of treatment is ≥ 6 months and on a stable dose for at least 3 months prior to the Baseline Visit

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Contraindication to MRI examination including, but not limited to, intracranial metal clips, heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators, metal hip replacements, profound claustrophobia or inability to lie in the MRI machine in an appropriate position to obtain quality images, history of hypersensitivity to gadolinium contrast agent
• Severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockroft-Gault equation), which would prevent the use of gadolinium enhancement
• History of clinically significant (as determined by the investigator) cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
• Prior history of suicide attempt at any time in the subject's lifetime prior to signing the informed consent, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
• Pregnant or breast feeding
• Active substance abuse or a history of substance abuse within 6 months prior to screening
• History of allergy or hypersensitivity to any component of the IP
• History of rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption
• History of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease)
• Active tuberculosis or a history of incompletely treated tuberculosis
• Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to screening and no new or recurrent infections prior to the Baseline Visit
• Malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;
• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following Baseline Visit

Sponsors & Collaborators

• Amgen: lead

Study Sites (36)

The Doctors of Saint John's Medical Group

Santa Monica, California, 90404, United States

Location

Inland Rheumatology Clinical Trials Inc

Upland, California, 91786, United States

Location

Malcom Randall VA Medical Center

Gainesville, Florida, 32610, United States

Location

Integral Rheumatology and Immunology Specialists

Plantation, Florida, 33324, United States

Location

NYU Langone Medical Center

New York, New York, 10003, United States

Location

Austin Regional Clinic

Austin, Texas, 78731, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Medizinische Universitat Wien

Vienna, 1090, Austria

Location

UZ Leuven

Leuven, 3000, Belgium

Location

University of Calgary - Cumming School of Medicine

Calgary, Alberta, T2N 4N1, Canada

Location

Alberta Rheumatology

Edmonton, Alberta, T5M 0H4, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 7W9, Canada

Location

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

Québec, Quebec, G1V 3M7, Canada

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Copenhagen University Hospital Rigshospitalet

Glostrup Municipality, 2600, Denmark

Location

Universitaetsklinikum Bonn

Bonn, 53127, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Johann Wolfgang Goethe University Hospital

Frankfurt am Main, 60590, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Location

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Ospedale Vittorio Emanuele

Catania, 95123, Italy

Location

Azienda Ospedaliera Regionale San Carlo

Potenza/Matera, 85100, Italy

Location

Udmurt Republic Republican Clinical Diagnostic Center

Izhevsk, 426009, Russia

Location

Research Institute of Rheumatology named after V.A.Nasonova

Moscow, 115522, Russia

Location

LLC Medical Center Zdorovaya Semiya

Novosibirsk, 630061, Russia

Location

Mechnikov North-Western State Medical University

Saint Petersburg, 191015, Russia

Location

Regional Clinical Hospital No 1 - Tyumen

Tyumen, 625032, Russia

Location

Hospital Virgen de Macarena

Seville, Andalusia, 41009, Spain

Location

Hospital Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Kantonsspital Aarau - KSA

Aarau, 5001, Switzerland

Location

Hopital Universitaire Genevois - Beau-Sejour Hospital

Geneva, 1206, Switzerland

Location

Kantonsspital St Gallen

Sankt Gallen, 9007, Switzerland

Location

NHS Lothian, Western General Hospital

Edinburgh, EH16 4TJ, United Kingdom

Location

The Leeds Teaching Hospitals NHS Trust - Chapel Allerton Hospital

Leeds, LS7 4SA, United Kingdom

Location

Southampton University Hospitals NHS Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Ostergaard M, Boesen M, Maksymowych WP, Lambert RG, Bubb MR, Kubassova O, Valenzuela G, Reddy J, Colgan S, Klyachkin Y, Deignan C, Zhou Z, Amouzadeh H, Mease PJ. Effect of apremilast on hand and whole-body MRI assessments of inflammation in patients with psoriatic arthritis (MOSAIC): a phase 4, multicentre, single-arm, open-label study. Lancet Rheumatol. 2025 Feb;7(2):e118-e126. doi: 10.1016/S2665-9913(24)00232-7. Epub 2024 Oct 30.

  PMID: 39488216 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

apremilast

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 20, 2018
• Study Start: February 6, 2019
• Primary Completion: October 26, 2021
• Study Completion: May 11, 2022
• Last Updated: February 21, 2025
• Results First Posted: December 19, 2022

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

DK (3); RU (5); CH (3); IT (2); GB (3); DE (4); BE (1); ES (3); US (7); CA (4); AU (1)