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Table 1 Summary of the different treatment arms applied in the NORD-STAR study

From: Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study

All patients: MTX, starting at 10 or 15 mg/week, escalated by 5 mg/week to 25 mg/week within 4 weeks.
To this is added 1 of 4 treatment arms below.
ARM 1A:
Aggressive csDMARD therapy followed by the investigators in Denmark and Finland:
MTX + SSZ + HCQ + i.a. glucocorticoids
SSZ: 1 g/day (first week), 2 g/day (second week and on)
HCQ: 35 mg/kg/weeka
i.a. injections of triamcinolonhexacetonid: 20 mg/mL or equivalent (maximum 4 joints or 4 ml per visit).
Injections must be given whenever clinically swollen joints are present. Priority to larger joints. Orally administered glucocorticoid is not allowed
ARM 1B:
Aggressive csDMARD therapy followed by the investigators in Iceland, Norway and Sweden:
MTX + p.o. glucocorticoids
Prednisolone: initially 20 mg/day, subsequently tapered in 9 weeks to 5 mg/day and discontinuation after 9 months.
Glucocorticoid injections (i.a.) of triamcinolonhexacetonid, 20 mg/mL or equivalent is allowed when clinically indicated
ARM 2:
bDMARD agent 1:
MTX + certolizumab-pegol
Certolizumab-pegol: 400 mg s.c. given at 0, 2 and 4 weeks, thereafter 200 mg s.c. every other week.
Glucocorticoid injections (i.a.) of triamcinolonhexacetonid, 20 mg/mL or equivalent is allowed when needed during the first 12 weeks. Thereafter, one to two injections (2 ml total or 40 mg) every 12 weeks.
Orally administered glucocorticoid is not allowed
ARM 3:
bDMARD agent 2:
MTX + abatacept
Abatacept: 125 mg s.c. every week.
Glucocorticoid injections (i.a.) of triamcinolonhexacetonid, 20 mg/mL or equivalent is allowed when needed during the first 12 weeks. Thereafter, one to two injections (2 ml total or 40 mg) every 12 weeks.
Orally administered glucocorticoid is not allowed
ARM 4:
bDMARD agent 3:
MTX + tocilizumab
Tocilizumab: 8 mg/kg i.v. every 4 weeks or 162 mg s.c. every week.
Glucocorticoid injections (i.a.) of triamcinolonhexacetonid, 20 mg/mL or equivalent is allowed when needed during the first 12 weeks. Thereafter, one to two injections (2 ml total or 40 mg) every 12 weeks.
Orally administered glucocorticoid is not allowed
  1. aIn Denmark and Finland the patients receive the standard-of-care dose of 200 mg/day and 200–300 mg/day respectively, since other doses are not available
  2. Abbreviations: bDMARD biological disease-modifying antirheumatic drugs, csDMARD conventional synthetic disease-modifying antirheumatic drugs, MTX, methotrexate, SSZ sulphasalazine, HCQ hydroxychloroquine, i.a. intra-articular, s.c. subcutaneous, i.v. intravenous, p.o. per os