TociCCAre - Clinical trial evaluating tocilizumab for the treatment of chondrocalcinosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2025-08-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Demonstrate the efficacy of IL-6 inhibition in treatment-refractory chronic inflammatory forms of CPP rheumatism

Secondary objectives 13

1. To compare changes in overall pain from baseline to M6
2. To compare the speed of pain resolution (improvement of more than 80% or pain less than 20 mm)
3. To compare response time to treatment (improvement of over 50%)
4. To compare the number of responding patients (improvement at M4)
5. To compare the number of relapses during the 6 months of the study
6. To compare healthcare consumption over the 6 months of the study: number of hospitalisations related to pain attacks, duration of hospitalisations, consumption of analgesics, duration of time off work
7. To compare quality of life and disability
8. To compare reactions to infusions
9. To compare severe infections
10. To compare decreases in neutrophils or platelets
11. To compare hepatic cytolysis
12. To compare lipid profiles
13. To determine the factors associated with a response to tocilizumab among demographic, disease, biological characteristics and comorbidities

Conditions and MedDRA coding

Chondrocalcinosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

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

Exclusion criteria 22

1. Presence of anti-CPP antibodies > 50 UI/mL
2. Known hypersensitivity to the active substance or one of the excipients
3. Known severe immune deficiency
4. Patients not meeting classification criteria (cf. Appendix)
5. Concomitant treatment with biological or targeted therapy, or immunosuppressive therapy (including methotrexate, leflunomide, azathioprine)
6. Previous treatment with tocilizumab
7. Dyslipidaemia, hypertension or poorly controlled cardiovascular disease
8. Scheduled surgery
9. Difficulty in understanding French, Illiteracy
10. Pregnant women, women in labor or nursing mothers
11. Recurrent or chronic infections
12. 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
13. Persons of full age under legal protection or unable to give their consent
14. Persons not affiliated to a social security scheme or beneficiaries of such a scheme
15. Participation in another interventional study
16. History of severe infection (= requiring hospitalization)
17. Active infection
18. Vaccination with a live or attenuated vaccine in the 4 weeks prior to inclusion
19. History of infectious sigmoiditis
20. Untreated latent tuberculosis
21. Neutropenia < 1000 elements/mm³, thrombocytopenia < 100 000/mm³
22. Elevated transaminases > 3 x ULN

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 18

1. 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
2. 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)
3. Proportion of patients responding from M2 to M6 (defined as an improvement ≥ 50% of the initial pain VAS)
4. Proportion of complete response, defined as an improvement ≥ 80% of the initial pain VAS, from M2 to M6
5. Number of inflammatory flare-ups/month
6. Relapse rate at M6
7. Time to onset of relapse
8. Biological parameters of inflammation: SV, CRP, IL-6
9. Improvement in quality of life: SF-36, HAQ, EQ-5D-3L questionnaires
10. 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
11. Incidence of infusion reactions
12. Incidence of neutropenia, thrombocytopenia and hepatic cytolysis
13. Mean value of neutropenia, thrombocytopenia and transaminases
14. Incidence of severe infections
15. Incidence of any side effects attributable to treatment
16. Incidence of changes in lipid profile
17. Mean value of lipid profile
18. Demographic, disease, biological characteristics and comorbidities to identify factors linked to a response to tocilizumab

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Co-ordinating Investigator

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Co-ordinating Investigator

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications