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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

  1. The proportion of subjects who achieve remission with active conventional therapy (ACT) versus three different biologic therapies
  2. 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

Current status

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.

Expected significance

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


Conventional combination treatment versus biological treatment in methotrexate-refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial.
van Vollenhoven R, Geborek P, Forslind K, Albertsson K, Ernestam S, Petersson I, et al
Lancet 2012 May;379(9827):1712-20

Comparison of combination therapy with single-drug therapy in early rheumatoid arthritis: a randomised trial. FIN-RACo trial group.
Möttönen T, Hannonen P, Leirisalo-Repo M, Nissilä M, Kautiainen H, Korpela M, et al
Lancet 1999 May;353(9164):1568-73

A randomized, double-blind, placebo-controlled study on addition of infliximab to the Fin-RACo DMARD combinatoin therapy for initial six months in patients with early active rheumatoid arthritis. The Neo-RACo study.
Leirisalo-Repo, M., et al., Ann Rheum Dis, 2008; 67 (Supp II):50.

Aggressive combination therapy with intra-articular glucocorticoid injections and conventional disease-modifying anti-rheumatic drugs in early rheumatoid arthritis: second-year clinical and radiographic results from the CIMESTRA study.
Hetland M, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen L, et al
Ann. Rheum. Dis. 2008 Jun;67(6):815-22

Adalimumab added to a treat-to-target strategy with methotrexate and intra-articular triamcinolone in early rheumatoid arthritis increased remission rates, function and quality of life. The OPERA Study: an investigator-initiated, randomised, double-blind, parallel-group, placebo-controlled trial.
Hørslev-Petersen K, Hetland M, Junker P, Pødenphant J, Ellingsen T, Ahlquist P, et al
Ann. Rheum. Dis. 2014 Apr;73(4):654-61