Authorised Therapeutic confirmatory (Phase III) Chondrocalcinosis

TociCCAre - Clinical trial evaluating tocilizumab for the treatment of chondrocalcinosis

EU CTIS ID: 2024-515956-19-00

What this study is testing

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

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Adults >18 years old
  • Diagnosis of PCP crystal deposit disease according to ACR/EULAR 2023 classification criteria
  • Persistent inflammatory pain (≥ 3 months) or ≥ 2 arthritis/month
  • Number of painful joints ≥ 3
  • Overall pain VAS (0_100) ≥ 40 mm
  • Failure, intolerance or inability to use the usual treatments repeatedly: colchicine, NSAIDs, corticosteroids and anakinra

You likely can't join if

  • Presence of anti-CPP antibodies > 50 UI/mL
  • Pregnant women, women in labor or nursing mothers
  • Recurrent or chronic infections
  • 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
  • Persons of full age under legal protection or unable to give their consent
  • Persons not affiliated to a social security scheme or beneficiaries of such a scheme
See the full eligibility criteria
Who can join
  • Adults >18 years old
  • Diagnosis of PCP crystal deposit disease according to ACR/EULAR 2023 classification criteria
  • Persistent inflammatory pain (≥ 3 months) or ≥ 2 arthritis/month
  • Number of painful joints ≥ 3
  • Overall pain VAS (0_100) ≥ 40 mm
  • Failure, intolerance or inability to use the usual treatments repeatedly: colchicine, NSAIDs, corticosteroids and anakinra
  • Use of an effective method of contraception in women of childbearing for up to 3 months after the end of the study
  • Patient who has given informed consent
What rules you out
  • Presence of anti-CPP antibodies > 50 UI/mL
  • Pregnant women, women in labor or nursing mothers
  • Recurrent or chronic infections
  • 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
  • Persons of full age under legal protection or unable to give their consent
  • Persons not affiliated to a social security scheme or beneficiaries of such a scheme
  • Participation in another interventional study
  • History of severe infection (= requiring hospitalization)
  • Active infection
  • Vaccination with a live or attenuated vaccine in the 4 weeks prior to inclusion
  • History of infectious sigmoiditis
  • Known hypersensitivity to the active substance or one of the excipients
  • Untreated latent tuberculosis
  • Neutropenia < 1000 elements/mm³, thrombocytopenia < 100 000/mm³
  • Elevated transaminases > 3 x ULN
  • Known severe immune deficiency
  • Patients not meeting classification criteria (cf. Appendix)
  • Concomitant treatment with biological or targeted therapy, or immunosuppressive therapy (including methotrexate, leflunomide, azathioprine)
  • Previous treatment with tocilizumab
  • Dyslipidaemia, hypertension or poorly controlled cardiovascular disease
  • Scheduled surgery
  • Difficulty in understanding French, Illiteracy

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.