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Study of tocilizumab compared to placebo in patients with chronic chondrocalcinosis who did not respond to standard treatments

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating chondrocalcinosis, a condition where calcium crystals build up in joint cartilage causing inflammation and pain. The study evaluates the effectiveness of tocilizumab, a medication given through intravenous infusion, in patients whose condition has not improved with standard treatments.

The study compares tocilizumab to placebo in patients with chronic inflammatory joint pain. The medication works by blocking a protein called IL-6 that is involved in inflammation. Participants will receive either tocilizumab or a sodium chloride solution (placebo) through an infusion into their vein once a month for three months.

During the study, patients will be monitored for changes in their pain levels and joint inflammation. The total duration of observation will be six months, with regular check-ups to assess how well the treatment is working and to monitor for any side effects. The medication being tested (tocilizumab) is available under different brand names including RoActemra, Tofidence, Avtozma, and Tyenne.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your first visit includes evaluation of pain levels using a Visual Analog Scale (VAS) that ranges from 0 to 100.

    Medical staff will count the number of painful and swollen joints.

    You will complete quality of life questionnaires (SF-36, HAQ, EQ-5D-3L).

    Blood tests will be performed to check inflammation markers.

  2. Step 2

    Treatment phase

    You will receive either tocilizumab or placebo through an intravenous infusion.

    The infusions will be given once per month for three months (at months 1, 2, and 3).

    Each visit includes evaluation of your pain levels and joint examination.

    Blood tests will be conducted to monitor your health status.

  3. Step 3

    One-month follow-up

    One month after your third infusion (month 4), you will have a follow-up visit.

    Pain levels and joint examination will be performed.

    Blood tests will be conducted to check inflammation markers.

    Quality of life questionnaires will be completed.

  4. Step 4

    Final evaluation

    The final visit occurs at month 6.

    Pain levels and joint examination will be performed for the last time.

    Final blood tests will be conducted.

    You will complete the final set of quality of life questionnaires.

    Medical staff will review any health changes that occurred during the study period.

Who can join the trial?

11 criteria

  • Must be at least 18 years old
  • Must have confirmed calcium pyrophosphate crystal deposit disease (a condition where calcium crystals build up in joints) diagnosed according to specific medical criteria
  • Must have ongoing joint pain lasting more than 3 months or at least 2 episodes of joint inflammation per month
  • Must have pain in more than 3 joints
  • Must have pain intensity greater than 40 on a 100-point scale where 0 means no pain and 100 means worst possible pain
  • Must have tried and failed to improve with standard treatments including:
    • Colchicine (medicine for inflammation)
    • NSAIDs (non-steroidal anti-inflammatory drugs)
    • Corticosteroids (anti-inflammatory hormones)
    • Anakinra (medication that reduces inflammation)
    • Women who can become pregnant must use effective birth control during the study and for 3 months after the study ends
    • Must be willing and able to provide informed consent (written agreement to participate after understanding study details)

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Any active or chronic infection, including tuberculosis (an infectious bacterial disease affecting the lungs)
  • Presence of autoimmune diseases (conditions where the immune system attacks healthy body tissues)
  • History of severe allergic reactions to medications
  • Current pregnancy or breastfeeding
  • Significant kidney or liver disease
  • Uncontrolled hypertension (high blood pressure)
  • Active or recent cancer within the past 5 years
  • Major surgery within 8 weeks before the start of the study
  • Use of other investigational drugs within 30 days before the study
  • Severe heart conditions or recent heart attack
  • History of blood disorders or significant bleeding problems
  • Immunodeficiency (weakened immune system) or use of immunosuppressive drugs
  • Severe mental health conditions that could interfere with study compliance
  • Alcohol or drug abuse within the past 6 months
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Investigated drugs

Tocilizumab is a medication that works by blocking a protein in the body called interleukin-6 (IL-6), which is involved in causing inflammation. It is used to treat various inflammatory conditions. In this trial, it is being studied for its potential to help patients with chronic calcium pyrophosphate crystal arthritis (also known as pseudogout) who haven't responded well to standard treatments. The medication is given by injection and works by reducing inflammation in the joints.

What is already known about the treatment

Tocilizumab - An advanced biological medication administered through intravenous infusion or subcutaneous injection that works by blocking interleukin-6 (IL-6), a protein involved in inflammatory processes. This monoclonal antibody is currently approved for treating several inflammatory conditions, and in this trial, it's being studied for chondrocalcinosis (calcium pyrophosphate deposition disease). Tocilizumab belongs to the class of disease-modifying antirheumatic drugs (DMARDs) and works by reducing inflammation and preventing joint damage by specifically targeting the IL-6 receptor, which plays a crucial role in the body's inflammatory response.

Investigated diseases

Chondrocalcinosis - A condition where calcium-containing crystals build up in the joints and their surrounding tissues. The crystals typically form in the cartilage, which is the smooth tissue that covers the ends of bones where they meet to form joints. Over time, these deposits can lead to joint inflammation and swelling, causing symptoms similar to arthritis. The condition most commonly affects the knees, wrists, and other joints. Chondrocalcinosis can develop gradually and may be discovered by chance on X-rays before causing any symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515956-19-00Protocol codeAPHP220790Estimated enrolment80 patientsSponsorAssistance Publique Hopitaux De Paris

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