Health TrialsbyHealthPanel

Tocilizumab in Chronic Inflammatory CPPD Disease

ConditionCalcium Pyrophosphate Deposition Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Presence of anti-CPP antibodies > 50 IU/ml

Recurrent or chronic infections

History of severe infection (= requiring hospitalization)

Active infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Other intervention

    Saline placebo, IV infusion / month for 3 months

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TocilizumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Change in the number of swollen and tender joints

Disease Activity Score (DAS44), number of swollen and painful joints, Patient assessment of overall disease activity by a visual analogue scale (VAS) ranging from 0 (no activity) to 100 mm (maximal activity). Those outcomes will be assessed at inclusion, before each infusion at months M1, M2, M3, then at M4 (primary outcome) and M6

Time frame
6 months
2

Overall effect on pain

Area under the curve (AUC) of the overall pain visual analogue scale (VAS) ranging from 0 (no pain) to 100 mm (worst pain ever experienced) based on assessments at baseline, before each infusion at months M1, M2, M3 and at M4 and M6 (end of the study). Overall pain VAS will be collected after a 24-hour washout of analgesics.

Time frame
6 months
3

Response to treatment / relapse

Response to treatment will be defined as an improvement ≥ 50% of initial pain visual analogue scale (VAS) ranging from 0 (no pain) to 100 mm (worst pain ever experienced) Complete response will be defined as an improvement ≥ 80% of initial pain VAS This outcome will be assessed from M2 to M6. Relapse will be assessed in responders at 6 months, and the time from response to relapse will be determined.

Time frame
6 months
4

Flares (ESR)

Outcome Measures - Inflammatory Biomarkers Erythrocyte Sedimentation Rate (ESR) Unit: millimeters (mm) Frequency: measured at each visit No aggregation of this measure is planned to produce a composite value. If aggregation is considered (e.g., to generate an overall inflammation score), a validated statistical method will be specified.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Fresenius AG

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: