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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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Hopital Beaujon Clichy France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Cktxro Huxvfabzfjb Ihoteijsswlsj Lv Rvtspdvelssioutpi Monfermeil France
Cozrvg Hvpvaqcwrwg Uvmslowtaizhg Dh Ddukt Dijon France
Iemnlhor dm Cjrftfdoagjl Hdlkpydlakc Ukpaykiwxshlf dp Srqvz Euuecdp (sagxwbr Saint Priest En Jarez France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.10.2025

Trial locations

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.

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 ID:
2024-515956-19-00
Protocol code:
APHP220790
Trial Phase:
Therapeutic confirmatory (Phase III)

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