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TociCCAre - Randomized, double-blind, multicenter trial of tocilizumab versus placebo in chronic polyarticular inflammatory of calcium pyrophosphate deposition disease refractory to standard treatments

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515956-19-00
Acronym
APHP220790
Enrollment
80
Registered
2025-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chondrocalcinosis

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

DRUGTofidence 20 mg/mL concentrate for solution for infusion
DRUGAvtozma 20 mg/mL concentrate for solution for infusion.
DRUGRoActemra 20 mg/mL concentrate for solution for infusion
DRUGSODIUM CHLORIDE

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Variation in overall pain VAS between initiation and M4, i.e. one month after the 3rd infusion

Secondary

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026