All patients: MTX, starting at 10 or 15Â mg/week, escalated by 5Â mg/week to 25Â mg/week within 4Â weeks. | |
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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 |