Ireland
--:--IST
Starting soon Phase 4

Tdose Binding and Tocilizumab

NCT07582185 · tracked via the Priya Life Science France tracker
Phase
Phase 4
Started
2026-06-01
Last updated
2026-05-12

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

Experimental: dose binding armActive Comparator: traditionnal arm: Weight-based dosing

Experimental: dose binding arm: TOCILIZUMAB administered at standardized, fixed-interval doses versus weight-based dosing

Active Comparator: traditionnal arm: Weight-based dosing: standart administration; weight-based dosing

Study summary

The investigators aim to evaluate the non-inferiority of administering tocilizumab at a fixed dose versus a weight-based dose in patients with rheumatoid arthritis in remission or with low clinical activity, after 3 months of treatment, as part of a two-center randomized trial.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of rheumatoid arthritis according to ACR/EULAR criteria * Rheumatoid Arthritis in low activity or remission according to DAS28 * Patient to receive a TOCILIZUMAB infusion 8mg/kg * Patient with failure of treatment with cDMARDs or bDMARDs * Concomitant treatment(s) for rheumatism allowed: stable doses for at least 3 months of cDMARDs, NSAIDs, analgesics, or corticosteroid therapy (\< 10 mg/day of prednisone equivalent) Exclusion Criteria: * Active neoplasia * Treatment with TOCILIZUMAB for an indication other than rheumatoid arthritis * Treatment with TOCILIZUMAB at a dosage other than 8 mg/kg * Diverticulitis or history of digestive perforation

Primary outcome measure(s)

  • disease activity — month 3
    DAS28 (0 to 28)

Trial sites (1)

FacilityCityRegionStatus
CHU de Nice Nice France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07582185 on ClinicalTrials.gov ↗ ← All trials in France