Ireland
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Starting soon Phase 2

Tocilizumab in Chronic Inflammatory CPPD Disease

NCT07254637 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2026-04
Last updated
2026-01-14

Condition(s) studied

Calcium Pyrophosphate Deposition Disease

Investigational drug(s) / intervention(s)

Tocilizumab →Placebo

Tocilizumab: Tocilizumab, 8 mg/kg/month, IV infusion for 3 months Tocilizumab, an anti-IL-6R monoclonal antibody, was approved in January 2009 for the treatment of rheumatoid arthritis. Its indications have since been extended, particularly for the treatment of giant cell arteritis, juvenile chronic arthritis, and severe cytokine release syndrome induced by chimeric antigen receptor T-cell (CAR-T) therapy.

Placebo: Saline placebo, IV infusion / month for 3 months

Study summary

The aim of this clinical trial is to determine the efficacy of tocilizumab (an IL-6 inhibitor) in treatment-refractory chronic inflammatory forms of CPPD.

The main questions this trial aims to answer are:

* Can tocilizumab improve joint pain in patients with chronic inflammatory CPPD disease?
* Does tocilizumab improve quality of life in patients with chronic inflammatory CPPD disease?

Participants will receive a monthly infusion of tocilizumab or placebo for three months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults \> 18 years * Diagnosis of CPPD according to ACR/EULAR 2023 classification criteria * Persistent inflammatory pain (\> 3 months) or ≥ 2 arthritics/month * Number of painful joints (NAD) \> 3 * Overall pain VAS (0\_100) \> 40 mm * Failure, intolerance or impossibility of repeated use of usual treatments: colchicine, NSAIDs, corticosteroids and anakinra * Use of an effective method of contraception in women of childbearing age until 3 months after the end of the study. * Informed consent Exclusion Criteria: * Presence of anti-CPP antibodies \> 50 IU/ml * Recurrent or chronic infections * History of severe infection (= requiring hospitalization) * Active infection * Vaccination with live or attenuated vaccine within 4 weeks prior to inclusion * History of intestinal ulceration or diverticulitis Untreated latent tuberculosis * History of viral hepatitis B ou C * Symptoms suggestive of demyelinating disease of the central nervous system * History of cancer, active cancer, or suspected cancer * Neutropenia \< 2000 elements/mm3, thrombocytopenia \< 100 000/mm3 * Elevated transaminases \> 3 x ULN * Known hypersensitivity to the active substance or one of the excipients; * Known severe immune deficiency * Patients not meeting classification criteria * Concomitant treatment with biological or targeted therapies, or immunosuppressive therapy (including methotrexate, leflunomide, azathioprine), systemic corticosteroids, anakinra, IL-6 inhibitors in subcutaneous injection, anti-TNF agents, and JAK. If these treatments are used before inclusion, a washout period corresponding to at least five times their respective mean terminal half-life must be respected. * inhibitors. * Previous treatment with tocilizumab * Concomitant treatment with methylprednisolone, dexamethasone, atorvastatin, calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, cyclosporine or benzodiazepines * Dyslipidemia, hypertension or poorly controlled cardiovascular disease * Scheduled surgery * Difficulty to understand French, illiteracy * Pregnant women, women in labor or nursing mothers * Persons deprived of their liberty, adults under legal protection or unable to express their consent * Persons not affiliated to a social security scheme or beneficiaries of such a scheme * Participation in another interventional study

Primary outcome measure(s)

  • Change in overall pain VAS — 6 months
    Overall pain will be assessed, after 24 hours of discontinuation of analgesics, using a visual analogue scale (VAS) ranging from 0 (no pain) to 100 mm (worst pain ever experienced), at inclusion, before each infusion at months M1, M2, M3, then at M4 (primary outcome) and M6.

Trial sites (12)

FacilityCityRegionStatus
Groupe Hospitalier de l'Institut Catholique de Lille Lomme Lille
Lariboisière hospital Paris Paris Paris
Centre Hospitalier Sud-Francilien Corbeil-Essonnes Paris
CHU de Dijon Dijon France
CHU de Nantes Nantes France
Hôpital Bichat Claude-Bernard Paris France
Hôpital de la Croix Saint-Simon Paris France
Hôpital Tenon Paris France
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil Paris France
Hôpital Le Kremlin Bicêtre Paris France
CHU de Rennes Rennes France
CHU de Saint-Étienne Saint-Etienne France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07254637 on ClinicalTrials.gov ↗ ← All trials in France