Chondrocalcinosis
Conditions
Brief summary
Variation in overall pain VAS between initiation and M4, i.e. one month after the 3rd infusion
Detailed description
DAS44, number of swollen, painful joints, overall disease activity VAS, fatigue VAS, Overall effect on pain: area under the curve (AUC) of global pain VAS from assessments at inclusion, before each infusion at months M1, M2, M3 and at M4 and M6 (end of study), Proportion of patients responding from M2 to M6 (defined as an improvement ≥ 50% of the initial pain VAS), Proportion of complete response, defined as an improvement ≥ 80% of the initial pain VAS, from M2 to M6, Number of inflammatory flare-ups/month, Relapse rate at M6, Time to onset of relapse, Biological parameters of inflammation: SV, CRP, IL-6, Improvement in quality of life: SF-36, HAQ, EQ-5D-3L questionnaires, Consumption of care over 6 months: number of hospitalisations related to CPAP-dependent disease, duration of hospitalisations, duration of time off work, consumption of analgesics, Incidence of infusion reactions, Incidence of neutropenia, thrombocytopenia and hepatic cytolysis, Mean value of neutropenia, thrombocytopenia and transaminases, Incidence of severe infections, Incidence of any side effects attributable to treatment, Incidence of changes in lipid profile, Mean value of lipid profile, Demographic, disease, biological characteristics and comorbidities to identify factors linked to a response to tocilizumab
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in overall pain VAS between initiation and M4, i.e. one month after the 3rd infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| DAS44, number of swollen, painful joints, overall disease activity VAS, fatigue VAS, Overall effect on pain: area under the curve (AUC) of global pain VAS from assessments at inclusion, before each infusion at months M1, M2, M3 and at M4 and M6 (end of study), Proportion of patients responding from M2 to M6 (defined as an improvement ≥ 50% of the initial pain VAS), Proportion of complete response, defined as an improvement ≥ 80% of the initial pain VAS, from M2 to M6, Number of inflammatory flare-ups/month, Relapse rate at M6, Time to onset of relapse, Biological parameters of inflammation: SV, CRP, IL-6, Improvement in quality of life: SF-36, HAQ, EQ-5D-3L questionnaires, Consumption of care over 6 months: number of hospitalisations related to CPAP-dependent disease, duration of hospitalisations, duration of time off work, consumption of analgesics, Incidence of infusion reactions, Incidence of neutropenia, thrombocytopenia and hepatic cytolysis, Mean value of neutropenia, thrombocyto | — |
Countries
France