Phase 4 study of Apremilast in patients with psoriatic arthritis
Research type
Research Study
Full 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 non-steroidal anti-inflammatory drugs (NSAIDs) and/or ≤1 conventional synthetic disease-modifying antirheumatic drugs (DMARD).
IRAS ID
253603
Contact name
James Galloway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2018-002735-26
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
101761, IND
Duration of Study in the UK
1 years, 10 months, 29 days
Research summary
Psoriatic arthritis (PsA) is an autoimmune disease, which means that the body’s immune system (cells that protect our bodies by fighting infections) mistakenly attacks healthy tissues. The affected joints become inflamed, and as a result, become swollen, stiff and painful. This disease develops in about a third of patients with a skin condition, psoriasis, which usually becomes affected prior to involvement of the joints.
Patients with the oligoarthritis subtype (fewer joints involved, usually up to 4) of PsA were included in previous clinical trials with Apremilast, although considerably underrepresented due to pre-specified inclusion criteria. This study specifically focuses on patients with involvement of fewer joints than previously required in prior studies with apremilast.
The current study is sponsored by Celgene corporation. It is designed to evaluate the benefit and risk of apremilast in patients who have been diagnosed with PsA during the last 2 years (≤ 24 months). To participate in this study, patients must present inflammation in a limited number of joints (up to 4 swollen and up to 4 tender joins), despite taking stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and/or a disease-modifying anti-rheumatic drug (DMARD).
The medication that will be tested in this study is called apremilast. Apremilast works by decreasing some of the chemicals that cause inflammation and has been shown to be safe and effective in relieving signs and symptoms of PsA, as well as improving physical condition and quality of life. Apremilast is approved and marketed as a pill called Otezla for the treatment of PsA and psoriasis.
Study procedures will include blood and urine analysis, vital signs, physical examinations and questionnaires.
Approximately 330 participants worldwide will participate in this study. The study duration is up to 56 weeks and patients may receive study treatment for a maximum of 48 weeks.
REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/0149
Date of REC Opinion
29 Mar 2019
REC opinion
Further Information Favourable Opinion