Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Laura Coates
+44 (0)1865 737905
laura.coates@ndorms.ox.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Severe psoriatic arthritis – early intervention to control disease

Severe psoriatic arthritis – early intervention to control disease

Medical Conditions

Psoriatic arthritis


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.


Psoriatic arthritis (PsA) is a type of inflammatory arthritis that can cause pain and joint damage if left untreated. We have already shown that a ‘Treat to Target’ approach where treatment is increased until a target was achieved for the patients for improved arthritis, psoriasis, quality of life, pain and function. However, there are no studies looking at which drugs work best in this ‘Treat to Target’ approach. The usual strategy is ‘step-up’ approach for all patients, whether they have mild or severe disease. This means at first one standard arthritis drug is used, then two standard drugs together and finally newer stronger biologic drugs for patients not responding to the other drugs. Previous studies in patients with severe disease suggested they may do better if they are treated with stronger drugs earlier. So the aim of this study is to see if patients with moderate to severe PsA do better if they start treatment with two drugs together at the beginning of their treatment or if they start on a biologic drug from the beginning.

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:

31 May 2019 31 Jan 2024

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38826570/ (added 28/02/2025)

Participants are randomly allocated to one of three treatment groups receiving: (1) the standard ‘step-up’ of arthritis drugs – receiving the standard drugs before the stronger biologics; (2) two standard arthritis drugs together; (3) stronger biologic therapy at the start. They have 12 weekly appointments up to 48 weeks which include clinical assessments of their PsA, blood tests and completion of questionnaires.


Patients recently diagnosed with moderate to severe PsA who have not previously taken any disease-modifying drugs (DMARDs) for arthritis.

You can take part if:



You may not be able to take part if:


1. Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazine, leflunomide and ciclosporin2. Female patient who is pregnant, breast-feeding or planning pregnancy during the course of the trial.3. Significant renal or hepatic impairment.4. Patients who test positive for Hepatitis B, C or HIV.5. Contraindication to any of the investigative drugs.6. Currently abuse drugs or alcohol7. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.8. Life expectancy of less than 6 months.9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put patients at risk because of participation in the trial, or may influence the result of the trial, or their ability to participate in the trial.10. Participation in another research trial involving an investigational product in the past 12 weeks.11. Additional exclusion criteria apply to patients randomised to arm 3 and receiving adalimumab therapy:11.1 Active tuberculosis (TB), chronic viral infections, recent serious bacterial infections, those receiving live vaccinations within 3 months of the anticipated first dose of study medication, or those with chronic illnesses that would, in the opinion of the investigator, put the participant at risk. 11.2 Latent TB unless they have received appropriate anti-tuberculous treatment as per local guidelines11.3 History of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ.


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

  • Cambridge University Hospitals NHS Foundation Trust
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ
  • Oxford University Hospitals NHS Foundation Trust
    John Radcliffe Hospital Headley Way Headington
    Oxford
    OX3 9DU
  • Torbay And South Devon NHS Foundation Trust
    Torbay Hospital Newton Road
    Torquay
    TQ2 7AA
  • Freeman Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Royal United Hospitals Bath NHS Foundation Trust
    Combe Park
    Bath
    BA1 3NG
  • The Royal Wolverhampton NHS Trust
    New Cross Hospital Wolverhampton Road Heath Town
    Wolverhampton
    WV10 0QP
  • Wirral University Teaching Hospital NHS Foundation Trust
    Arrowe Park Hospital Arrowe Park Road Upton
    Wirral
    CH49 5PE
  • Royal National Orthopaedic Hospital NHS Trust
    Brockley Hill
    Stanmore
    HA7 4LP
  • Christchurch Hospital
    Fairmile Road
    Christchurch
    BH23 2JX
  • University Hospital
    Clifford Bridge Road
    Coventry
    CV2 2DX
  • County Durham and Darlington NHS Foundation Trust
    Darlington Memorial Hospital Hollyhurst Road
    Darlington
    DL3 6HX
  • East Suffolk and North Essex NHS Foundation Trust
    Colchester Dist General Hospital Turner Road
    Colchester
    CO4 5JL
  • Haywood Hospital
    Burslem
    Stoke-on-trent
    ST6 7AG

The drugs to be used are all current standard treatments for PsA, each with known safety profiles and side effects. The difference for participants is the timing of treatment and therefore the risk of side effects of the treatments received. The potential benefit is an improvement in symptoms and quality of life at an earlier timepoint but this is exploratory as yet.

Dr Laura Coates
+44 (0)1865 737905
laura.coates@ndorms.ox.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Oxford and funded by NIHR Academy; Grant Codes: CS-2016-16-016.





We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: ISRCTN70603700
Last updated 28 February 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.