CITAR - Comparison of the efficacy and safety of early use of IL-6R blockade with tocilizumab in combination with short-term glucocorticoids versus glucocorticoids alone for the treatment of arthritis induced by cancer immunotherapy by check point inhibitors: a randomized, open, multicentre, proof of concept, superiority, controlled clinical trial

Patients with histologically (or via cytology) confirmed cancer that develop arthritis secondary to treatment with immune checkpoint inhibitors.

% of patients in arm A and arm B with Clinical Disease Activity Index (CDAI): CDAI ≤10 at week 16

1. % of patients in arm A and arm B with Clinical Disease Activity Index (CDAI): CDAI ≤10 at week 24, 2. % of patients in arm A and arm B with CDAI ≤2.8 at week 16 and 24, 3. % of patients in arm A and arm B with CDAI ≤10 AND Prednisolone 0-5mg/d at week 16 and 24, 4. % of patients in arm A and arm B with CDAI ≤10 AND Prednisolone 0 mg/d at week 16 and 24, 5. Improvement in pain (VAS 0-100mm), general health (VAS 0-100mm), fatigue (VAS 0-100mm), functional status (HAQ questionnaire) and quality of life (EQ5D questionnaire) in arm A and B, at week 16 and 24, 6. Progression-free survival and overall survival of patients in arm A and arm B at week 16 and 24, 7. Total number of missed treatment cycles with ICI, at week 24, 8. % of patients with AEs and SAEs in arm A and B from baseline to week 24

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France, Sweden