MDR-RA
The Norwegian study for therapeutic pharmacovigilance
Project managers
Co-lead
ABOUT THE PROJECT
This is an EU-funded, European, multi-center study (23 centers including 16 clinical centers, 12 countries) with the aim of studying rheumatoid arthritis (RA) patients who are difficult to treat ("difficult to treat RA" as defined by EULAR) in order to develop the best possible treatment for this group. The study will use cohorts we already have to develop algorithms for mapping these patients.
A prospective study of a total of 80 patients (5-6 patients from REMEDY) within this patient group will be started in early 2025, where these patients will be extensively surveyed clinically, with biopsy, synovial fluid and blood test examinations, with quantitative pain mapping and with a number of questionnaires including pain, fatigue and function.
The knowledge from the prospective study, together with knowledge from the cohorts we already have, will be used to develop the best possible treatment strategy to be used in a randomized study where a new, optimized treatment strategy is compared with the usual treatment plan. This randomized study will use randomization per center.
WHO CAN JOIN?
Patients with RA that is "difficult to treat" according to the EULAR definition.
WHAT DOES THE STUDY INVOLVE?
There are two studies:
The first is a 12-month study with controls every 3 months, with the study starting in 2025.
At baseline, an ultrasound-guided biopsy of an inflamed joint should be taken and a quantitative pain assessment should be performed.
At all visits, there is a broad assessment with clinical and ultrasound examinations, laboratory tests and questionnaires, and at the final visit, in addition, a new quantitative pain assessment.
The randomized study will start in 2028, where REMEDY will be randomized to either treat patients according to an algorithm developed in the study to provide the best possible treatment or to have patients treated as we usually do.