MDR-RA
The Norwegian study for therapeutic drug monitoring
Project managers
Co-lead
ABOUT THE PROJECT
This is an EU funded, European, multi-center study (23 centers including 16 clinical centers, 12 countries) aimed at studying arthritis (RA) patients who are difficult to treat ("Difficult to Treat RA" defined by EULAR) in order to be able to Develop the best possible treatment for this group. The study will use cohorts we already have to develop algorithms for mapping these patients.
It will be in the Primo 2025 a prospective study of a total of 80 patients (5-6 patients from Remedy) within this patient group where these patients will be very widely mapped clinically, with biopsy, joint fluid and blood test studies, with quantitatory pain mapping as well as with A variety of questionnaires including pain, fatigue and function.
The knowledge of the prospective study, together with the 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 to the usual treatment program. This randomized study will use randomization per center.
WHO CAN JOIN?
Patients with RA who are "diffused to treat" according to the EUS definition.
WHAT DOES THE STUDY INCLUDE?
There are two studies:
The first is a 12 month study with control every 3 months, with the start of the study in 2025.
In the baseline, the ultrasound-guided biopsy of an inflamed joint and a quantitatory pain mapping should be taken.
In all visits, there is a broad survey with clinical and ultrasound examinations, laboratory tests and questionnaires, and at the final visit in addition a new quantitatory pain mapping.
The randomized study starts 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 the patients are treated as we usually do.