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

• Published in: Current controlled trials in cardiovascular medicine 2024-11, Vol.25 (1), p.758-15, Article 758
• Main Authors: Bergstra, S A, van Ouwerkerk, L, Nevins, I S, van der Pol, J A, Helmich, G S, Hest, I, van Veen, A, Bos, R, Goekoop-Ruiterman, Y P M, Vonkeman, H E, Bijsterbosch, J, de Jong, P H P, Güler-Yüksel, M, Böhringer, S, Huizinga, T W J, van Gaalen, F A
• Format: Article
• Language: English
• Subjects: Antirheumatic Agents - adverse effects; Antirheumatic Agents - therapeutic use; Arthritis - drug therapy; Azetidines - adverse effects; Azetidines - therapeutic use; Baricitinib; Clinical outcomes; Clinical trials; Decision making; Humans; Kinases; Medical ethics; Medical treatment; Methotrexate; Methotrexate - adverse effects; Methotrexate - therapeutic use; Multicenter Studies as Topic; Netherlands; NSAID; Patients; Purines - adverse effects; Purines - therapeutic use; Pyrazoles - adverse effects; Pyrazoles - therapeutic use; Randomized; Randomized Controlled Trials as Topic; Remission (Medicine); Remission Induction; Rheumatoid arthritis; Single-Blind Method; Spontaneous remission; Study Protocol; Sulfonamides - adverse effects; Sulfonamides - therapeutic use; Time Factors; Treatment Outcome; Undifferentiated arthritis
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-024-08609-5

Undifferentiated arthritis (UA) is a term used to describe patients with inflammatory arthritis that has not differentiated into a specific rheumatic disease. UA may be a pre-stage of rheumatoid arthritis (RA) or another inflammatory disease or remain undifferentiated, but a substantial proportion of patients may also achieve spontaneous remission. As UA may be an early presentation of RA, rheumatologists often start methotrexate (or another csDMARD) as early as possible. There are however very little data on the potential benefits of early DMARD treatment, and longitudinal data suggests that long-term outcomes such as physical functioning hardly improved in these patients in the past decades. In the I CEA trial, we investigate if it is beneficial to start early treatment with MTX or baricitinib, a more rapidly acting drug with a broader mechanism of action, compared to waiting for spontaneous remission with symptomatic therapy in patients with UA. The I CEA is a multicenter single-blind (independent assessor) randomized clinical trial with a 3-month interventional and 9-month observational follow-up period. The study includes patients with early (