MOSAIC PSA014
Research type
Research Study
Full title
A Phase 4, Multicenter, Single-Arm, Open-Label Study to Evaluate the Impact of Apremilast (CC-10004) on MRI Outcomes in Subjects with Psoriatic Arthritis
IRAS ID
251129
Contact name
Helena Marzo-Ortega
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2018-002748-10
Clinicaltrials.gov Identifier
2018-002748-10, EduraCT; 101761, IND NUMBER
Duration of Study in the UK
1 years, 4 months, 11 days
Research summary
Research Summary
Psoriatic arthritis is a heterogeneous inflammatory rheumatologic disorder characterized by inflammatory arthritis, enthesitis, dactylitis and spondylitis, affecting 6% to 39% of the patients suffering from psoriasis. Psoriatic arthritis may vary from a mild nonprogressive oligoarthritis to severe polyarticular disease, with great disability and reduced quality of life. These diverse clinical manifestations undermine general predictions regarding outcomes. Although Psoriatic arthritis has been historically conceived as a more benign arthropathy, in some patients it follows a particularly aggressive and deforming course. Hence, early diagnosis and treatment may have a significant beneficial effect on the natural course of this disease.
This study is designed to determine the impact of apremilast on imaging outcomes, assessed by both Magnetic Resonance Images of the most affected hand and whole body Magnetic Resonance Images, in biologic-naïve subjects with active Psoriatic arthritis, with more than 3 months and less than 5 years of disease duration, who had inadequate response to 2 or less Disease-modifying antirheumatic drugs (DMARDs). Apremilast has been approved for the treatment of PsA and psoriasis. It is under clinical investigation for the treatment of Behçet’s syndrome and inflammatory bowel disease. Apremilast has been shown to be efficacious in halting inflammation and reducing signs and symptoms of Psoriatic arthritis, as well as improving physical function. Whether apremilast can impact the structural progression of PsA has yet to be addressed. Apremilast will be provided by Celgene Corporation.
The purpose is to obtain preliminary evidence of the impact of apremilast on magnetic Resonance Images outcomes and structural progression of the disease. Over 120 patients will be participating all over the world.Summary of Results
PENDING: Lay summary of results will be updated on the European Union Clinical Trial Register
REC name
HSC REC B
REC reference
19/NI/0005
Date of REC Opinion
26 Feb 2019
REC opinion
Further Information Favourable Opinion