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Background
Background
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 study will go on for five years and 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:
a) The proportion of subjects who achieve remission with active conventional therapy (ACT) versus three different biologic therapies (Figure 1)
b) Two alternative de-escalation strategies in patients who respond to first-line therapy (Figure 2).
This study is divided into four treatment arms, all including methotrexate: 1) ACT; 2) Anti-TNF; 3) Abatacept; and 4) Tocilizumab
Figure 1
Figure 2
812 adult subjects with early rheumatoid arthritis have been enrolled from 29 investigative sites in the Nordic countries and the Netherlands. Countries in collaboration with the project include Sweden, Norway, Denmark, Finland, Iceland and the Netherlands.
The link to NORD-STAR on ClinicalTrials.gov may be found here. In addition, relevant literature includes the following studies: SWEFOT (1, 2), FinRACO, CIMESTRA, OPERA, and ARCTIC.
NORD-STAR gratefully acknowledges the support from:
Funders
Academy of Finland
Bristol-Myers Squibb
Finska Läkaresällskapet
Grant from the South-Eastern Health Region, Norway
HUCH Institutional grant, Finland
Icelandic Society for Rheumatology
Interregional grant from all health regions in Norway
NordForsk
Regionernes Medicinpulje, Denmark
Stockholm County Council
Swedish Research Council
Swedish Reumatism Association
The Research Fund of University Hospital, Reykjavik, Iceland
UCB
With sincere appreciation to these companies and councils!
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