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Fig. 2 | Trials

Fig. 2

From: Induction of Cure in Early Arthritis (I CEA): study protocol for an investigator-initiated randomized single-blind clinical trial with open-label extension to compare three treatment strategies in patients with newly diagnosed undifferentiated arthritis

Fig. 2

SPIRIT figure. Abbreviations: NSAID, non-steroidal anti-inflammatory drug; RR, respiration rate; P, pulse; temp, temperature; TBC, tuberculosis; MTX, methotrexate; SHS, Sharp/van der Heijde score; HAQ, health assessment questionnaire; SF-36, short form 36; MACTAR, McMaster-Toronto Arthritis Patient Preference Disability Index; EQ5D-3L, EuroQol-5 dimension-3 levels; HADS, hospital anxiety and depression scale; IPQ-K, Illness Perception Questionnaire-short; VAS, visual analog scale [1]. Hb, total WBC, absolute neutrophil count, absolute lymphocyte count, thrombocyte count, serum creatinine, AST, ALT, total cholesterol, HDL, and LDL [2]. erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) [3]. Anti-citrullinated protein antibodies (ACPA, including isotypes), Rheumatoid Factor, anti-carbamylated protein antibodies (anti-CarP), and other potentially newly discovered predictors of outcome [4]. TBC screening will be performed according to local guidelines in the participating center. In the LUMC, in which most patients have been included, this includes the Mantoux test (PPD) and Quantiferon [5]. X-rays are required if they were not performed and evaluated within approximately 6 months prior to screening [6]. joints presenting with clinical arthritis will be X-rayed for potential damage (progression) at baseline and, independent of the persistence of local clinical arthritis, at 12 months. In case of progression of arthritis, joints that become newly inflamed during the study may also be X-rayed if clinically relevant, but need no systematic follow-up X-ray at 12 months. * In exceptional cases study visits at weeks 2, 4, and 8 can be carried out by phone at which the research nurse will ask for pain, swelling, flexion, or extension limitation

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