CTIS.eu › Conditions › Adult patients of either gender with active moderate to severe rheumatoid arthritis (1987 revised ACR criteria; Arnett et al. 1987) of at least 6 months duration, with an inadequate response to cDMARDs and currently on treatment with stable doses of MTX for at least 8 weeks prior to randomisation will be eligible for the study. Up to 25% of patients might have also been previously exposed to bDMARDs. Patients with previous exposure to other cDMARD and bDMARD would enter the study after an adequate washout period. Patients previously exposed to JAK pathway inhibitors will not be allowed in the study.

Adult patients of either gender with active moderate to severe rheumatoid arthritis (1987 revised ACR criteria; Arnett et al. 1987) of at least 6 months duration, with an inadequate response to cDMARDs and currently on treatment with stable doses of MTX for at least 8 weeks prior to randomisation will be eligible for the study. Up to 25% of patients might have also been previously exposed to bDMARDs. Patients with previous exposure to other cDMARD and bDMARD would enter the study after an adequate washout period. Patients previously exposed to JAK pathway inhibitors will not be allowed in the study.

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A phase III, randomised, double-blind, multicentre study comparing the efficacy, safety, and immunogenicity of proposed tocilizumab biosimil … Not authorised

2022-501361-44-00 5

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