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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.
Prof
Costantino
Pitzalis
+44 (0)20 7882 8191
c.pitzalis@qmul.ac.uk
Ms
Alessia
Baseggio Conrado
+44 (0)20 7882 8191
emrclinicaltrials@qmul.ac.uk
Dr
Liliane
Fossati-Jimack
+44 (0)20 7882 7275
emrclinicaltrials@qmul.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Rheumatoid 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.
Rheumatoid arthritis (RA) is a chronic inflammatory disease, characterised by persistent synovitis (joint inflammation), systemic inflammation and autoantibodies (particularly rheumatoid factor and citrullinated peptide, thought to play critical roles in initiating inflammatory responses in RA). In industrialised countries, RA affects 0.5-1% of adults, with 5-50 per 100,000 new cases annually.
Despite the clinical and radiological benefits of biological therapies, the vast majority of patients fail to achieve low disease activity or remission. Almost 40% of all patients treated with biologic disease-modifying anti-rheumatic drugs (b-DMARDs) do not experience minimally acceptable improvement. Thus, the treatment of RA patients according to their biomarker would provide better care (avert delay in starting a more effective drug) and prevent unnecessary exposure to potentially toxic drugs and additionally be cost-saving.
We aim to test whether RNA signatures (biomarkers), in the tissue which surrounds the joints (synovial tissue) from patients with RA are predictive of response to drug treatments such as biologic disease-modifying anti-rheumatic drugs (b-DMARDs).
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:
You can take part if:
You may not be able to take part if:
The following exclusion criteria apply to the 3TR Precis-The-RA main study. All exclusion criteria but exclusion criteria number 23 apply to the Sub study:1. Women who are pregnant or breast-feeding2. Women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling to use an effective method of contraception (recommend double contraception) throughout the trial and beyond the end of trial treatment for the duration as defined in the relevant SmPC.3. History of or current primary inflammatory joint disease or primary rheumatological autoimmune disease other than RA (if secondary to RA, then the patient is still eligible).4. Prior exposure to any biologic/targeted DMARDs for RA5. Treatment with any investigational agent ≤ 4 weeks prior to baseline or < 5 half-lives of the investigational drug (whichever is the longer)6. Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to screening visit.7. Oral prednisolone more than 10mg/d or equivalent ≤ 4 weeks prior to baseline synovial biopsy.8. Active infection9. Known HIV, active Hepatitis B/C infection. Hepatitis B screening test must be performed at or in the preceding 3 months of screening visit.10. Septic arthritis of a native joint within the last 12 months11. Septic arthritis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ12. Latent TB infection unless they have completed adequate antibiotic prophylaxis13. Malignancy (other than basal cell carcinoma) within the last 10 years14. New York Heart Association (NYHA) grade III or IV congestive heart failure15. Demyelinating disease16. Known allergy to latex, or known hypersensitivity to the IMP active substance or to any of the excipients of the IMP17. Any other contra-indication to the study medications as detailed in the applicable SmPC18. Receipt of live vaccine <4 weeks prior to first IMP infusion or dose19. Major surgery in 3 months prior to first IMP infusion or dose20. Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening).21. Known recent substance abuse (drug or alcohol).22. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period23. Patients unable to tolerate synovial biopsy or in whom this is contraindicated including patients on anti-coagulants. Oral anti-platelet agents are permitted.24. Patients currently recruited to other clinical trials.25. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study26. Patients with severe hepatic impairment (Child Pugh C classification).27. Patients that are immunocompromised
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Alessia
Baseggio Conrado
+44 (0)20 7882 8191
emrclinicaltrials@qmul.ac.uk
Prof
Costantino
Pitzalis
+44 (0)20 7882 8191
c.pitzalis@qmul.ac.uk
Dr
Liliane
Fossati-Jimack
+44 (0)20 7882 7275
emrclinicaltrials@qmul.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 Queen Mary University of London and funded by Innovative Medicines Initiative 2 Joint Undertaking IMI2 JU.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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