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Be Part of Research - Trial Details - Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
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Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.

Completed

Open to: ALL

Age: 18.0 - N/A

Eastbourne London Derby Luton Torquay South Devon Truro Wolverhampton Edinburgh Scotland

Medical Conditions

Arthritis
Arthritis, Psoriatic

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2018 Dec 2022

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Subjects randomized to apremilast will receive dose-titration for the initial 5 days. Apremilast subjects will receive "dummy" titration at wk. 16 (for early escape subjects) and again at week 24 to maintain the blinding of the original treatment assignments. Investigational product (IP) will be dispensed in blinded dose cards until Week 28. Thereafter, IP will be dispensed in open-label bottles.

Intervention Arm Group : Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARD;

Intervention Type : OTHER
Intervention Description : Subjects randomized to placebo will receive "dummy" dose-titration for the initial 5 days. Placebo subjects who meet the criteria for early escape at wk. 16 may receive apremilast beginning at wk. 16 and will receive active titration. Remaining placebo subjects will receive active dose titration at week 24. Beginning at wk 24 all subjects will be dispensed active apremilast. Investigational product will be dispensed in blinded dose cards until Week 28. to maintain the blinding of the original treatment assignments. Thereafter, IP will be dispensed in open-label bottles

Intervention Arm Group : Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Eastbourne District General Hospital
    Eastbourne
    BN21 2UD
  • Kings College Hospital
    London
    SE5 9RS
  • Royal Berkshire Hospital
    Derby
    DE1 2QY
  • Luton and Dunstable University Hosptial
    Luton
    LU4 0DZ
  • Torbay Hospital
    Torquay South Devon
    TQ12 3JX
  • Royal Cornwall Hospitals Trust
    Truro
    TR1 3LJ
  • Wolverhampton Road
    Wolverhampton
    WV10 0QP
  • Western General Hospital
    Edinburgh Scotland
    EH4 2XU


The study is sponsored by Amgen




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Read full details for Trial ID: NCT03747939
Last updated 14 December 2023

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