Tocilizumab in Chronic Inflammatory CPPD Disease

NCT07254637 | Not Yet Recruiting Phase 2

• 1 other identifier: APHP220790
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Calcium Pyrophosphate Deposition Disease

Outcome Measures

Primary Outcomes (1)

• Change in overall pain VAS

  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.

  6 months

Secondary Outcomes (14)

• Change in the number of swollen and tender joints

  6 months

• Overall effect on pain

  6 months

• Response to treatment / relapse

  6 months

• Flares (ESR)

  6 months

• Flares (CRP)

  6 months

Study Arms (2)

Tocilizumab

EXPERIMENTAL

Drug: Tocilizumab

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Tocilizumab DRUG

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.

Tocilizumab

Placebo OTHER

Saline placebo, IV infusion / month for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of anti-CPP antibodies \> 50 IU/ml
• Recurrent or chronic infections
• History of severe infection (= requiring hospitalization)
• Active infection
• 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
• inhibitors.
• Previous treatment with tocilizumab

Sponsors & Collaborators

• Fresenius AG: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (12)

Groupe Hospitalier de l'Institut Catholique de Lille

Lomme, Lille, 59462, France

Location

Lariboisière hospital

Paris, Paris Paris, 75010, France

Location

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, Paris, 91100, France

Location

CHU de Dijon

Dijon, 21000, France

Location

CHU de Nantes

Nantes, 44000, France

Location

Hôpital Bichat Claude-Bernard

Paris, 75018, France

Location

Hôpital de la Croix Saint-Simon

Paris, 75020, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

Paris, 93370, France

Location

Hôpital Le Kremlin Bicêtre

Paris, 94270, France

Location

CHU de Rennes

Rennes, 35200, France

Location

CHU de Saint-Étienne

Saint-Etienne, 42100, France

Location

MeSH Terms

Conditions

Chondrocalcinosis

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Central Study Contacts

Augustin Latourte, Associate Professor

CONTACT

+33 1 49 95 62 90; augustin.latourte@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Pharmacy Process: Upon email notification, the pharmacy prepares and dispenses the tocilizumab or placebo. If unable to reconstitute it, they provide a nominative patient kit for external reconstitution. Non-protocol Handlers: Specially trained nurses reconstitute treatment bags discreetly. Each center has a designated trainer to build a team of these off-protocol handlers. Pharmacy Oversight: The hospital pharmacist ensures proper management of investigational products. Compliance is checked by a CRA during monitoring. Blinding Strategy: A blind CRA monitors clinical activities. An open CRA manages pharmacy stock and is aware of treatment allocation. The trial is double-blind to prevent bias for both patients and investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: TociCCAre is a phase II, randomised, double-blind, placebo-controlled comparative study. The study aims to demonstrate the efficacy of tocilizumab in treating chronic polyarticular inflammation associated with CPP crystals. It is a superiority study with 1:1 randomisation into two parallel groups. This multicentre study has 12 participating centres, including centres specialising in microcrystalline diseases and a reference centre for Gitelman syndrome (one of whose complications is extensive PPC crystal deposition), located at the HEGP hospital in Paris. Patients will be enrolled during consultations and hospitalisations by the principal investigator or their co-investigators.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: November 28, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2029
• Last Updated: January 14, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)