The design of the NORD-STAR (Nordic Rheumatic Diseases Strategy Trials And Registries) study is the result of a process during several years in which many Danish, Finnish, Icelandic, Norwegian, and Swedish rheumatologists collaborated to reach an optimal study design that follows normal clinical practice. NORD-STAR is a continuation of several investigator-initiated trials in the Nordic countries, including Fin-Raco and Neo-RACO in Finland, CIMESTRA and OPERA in Denmark, and Swefot in Sweden. The intention is that we will be able to answer some of the key questions that remain after these trials. The study is designed to resemble the clinical reality as much as possible, so that the implementation will not affect the normal clinical practice too much. The plan is to enroll 800 patients.
Description of the study
A multicenter, randomized, open-label, blinded-assessor, phase 4, international (Nordic) trial in patients with early rheumatoid arthritis
The overall aim is to compare
- The proportion of subjects who achieve remission with active conventional therapy (ACT) versus three different biologic therapies
- Two alternative de-escalation strategies in patients who respond to first-line therapy
If you want more information about the study, you can visit the website for NORD-STAR
Study start (First Patient First Visit): December 2012
Expected to be completed (Last Patient Last Visit): December 2021
Patient enrollment is ongoing at 11 centers in Sweden, four centers in Finland, five in Denmark, four in Norway and one on Iceland. Holland is ready to start.
To increase the understanding about what the optimal pharmaceutical treatment is for patients with early rheumatoid arthritis.
Principal Coordinating Investigator: Ronald van Vollenhoven
Study coordinator: Monica Ryden Aulin
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