TOCILIZUMAB for Chondrocalcinosis | Calcium pyrophosphate deposition disease

Inclusion criteria

• {"criterion_text":"- Adults >18 years old\n- Diagnosis of PCP crystal deposit disease according to ACR/EULAR 2023 classification criteria\n- Persistent inflammatory pain (≥ 3 months) or ≥ 2 arthritis/month\n- Number of painful joints ≥ 3\n- Overall pain VAS (0_100) ≥ 40 mm\n- Failure, intolerance or inability to use the usual treatments repeatedly: colchicine, NSAIDs, corticosteroids and anakinra\n- Use of an effective method of contraception in women of childbearing for up to 3 months after the end of the study\n- Patient who has given informed consent"}

Exclusion criteria

• {"criterion_text":"- Presence of anti-CPP antibodies > 50 UI/mL\n- Pregnant women, women in labor or nursing mothers\n- Recurrent or chronic infections\n- Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and persons admitted to a health or social establishment for purposes other than research\n- Persons of full age under legal protection or unable to give their consent\n- Persons not affiliated to a social security scheme or beneficiaries of such a scheme\n- Participation in another interventional study\n- History of severe infection (= requiring hospitalization)\n- Active infection\n- Vaccination with a live or attenuated vaccine in the 4 weeks prior to inclusion\n- History of infectious sigmoiditis\n- Known hypersensitivity to the active substance or one of the excipients\n- Untreated latent tuberculosis\n- Neutropenia < 1000 elements/mm³, thrombocytopenia < 100 000/mm³\n- Elevated transaminases > 3 x ULN\n- Known severe immune deficiency\n- Patients not meeting classification criteria (cf. Appendix)\n- Concomitant treatment with biological or targeted therapy, or immunosuppressive therapy (including methotrexate, leflunomide, azathioprine)\n- Previous treatment with tocilizumab\n- Dyslipidaemia, hypertension or poorly controlled cardiovascular disease\n- Scheduled surgery\n- Difficulty in understanding French, Illiteracy"}

Primary endpoints

• {"endpoint_text":"- Variation in overall pain VAS between initiation and M4, i.e. one month after the 3rd infusion","definition_or_measurement_approach":"Change in overall pain measured by Visual Analogue Scale (VAS) between initiation and M4 (one month after the 3rd infusion)."}

Secondary endpoints

• {"endpoint_text":"- DAS44 (If the erythrocyte sedimentation rate (ESR) is not available, the DAS28-CRP will be used), number of swollen, painful joints, overall disease activity VAS, fatigue VAS\n- 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)\n- Proportion of patients responding from M2 to M6 (defined as an improvement ≥ 50% of the initial pain VAS)\n- Proportion of complete response, defined as an improvement ≥ 80% of the initial pain VAS, from M2 to M6\n- Number of inflammatory flare-ups/month\n- Relapse rate at M6\n- Time to onset of relapse\n- Biological parameters of inflammation: SV, CRP, IL-6\n- Improvement in quality of life: SF-36, HAQ, EQ-5D-3L questionnaires\n- 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\n- Incidence of infusion reactions\n- Incidence of neutropenia, thrombocytopenia and hepatic cytolysis\n- Mean value of neutropenia, thrombocytopenia and transaminases\n- Incidence of severe infections\n- Incidence of any side effects attributable to treatment\n- Incidence of changes in lipid profile\n- Mean value of lipid profile\n- Demographic, disease, biological characteristics and comorbidities to identify factors linked to a response to tocilizumab","definition_or_measurement_approach":"- DAS44 (or DAS28-CRP if ESR unavailable); counts of swollen/painful joints; overall disease activity and fatigue measured by VAS\n- AUC of global pain VAS from scheduled assessments at inclusion, before each infusion (M1, M2, M3) and at M4 and M6\n- Proportion meeting ≥50% improvement in initial pain VAS between M2 and M6\n- Proportion meeting ≥80% improvement in initial pain VAS between M2 and M6\n- Number of inflammatory flare-ups per month recorded during study\n- Relapse rate assessed at M6\n- Time (duration) to onset of relapse measured from response\n- Inflammatory biomarkers: erythrocyte sedimentation rate (SV), C-reactive protein (CRP), interleukin-6 (IL-6)\n- Quality of life assessed by SF-36, HAQ, EQ-5D-3L questionnaires\n- Healthcare consumption metrics over 6 months: hospitalisations related to disease, hospitalisation duration, time off work, analgesic consumption\n- Recording and reporting of infusion reactions\n- Incidence and reporting of neutropenia, thrombocytopenia, hepatic cytolysis\n- Mean values of neutrophil count, platelet count and transaminases\n- Incidence of severe infections recorded\n- Incidence of any treatment-attributable adverse events\n- Incidence of lipid profile changes\n- Mean lipid profile values\n- Analysis of demographic, disease, biological characteristics and comorbidities to identify factors associated with response to tocilizumab"}

France

Earliest CTIS Part Ii Submission Date

11-07-2025

Latest Decision Or Authorization Date

11-02-2026

Processing Time Days

215

Number Of Sites

12

Number Of Participants

80

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France