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Tdose Binding and Tocilizumab

Not Yet RecruitingPhase 4

Sponsor: Centre Hospitalier Universitaire de Nice

Conditions: Rheumatoid Arthritis

Interventions: Experimental: dose binding arm, Active Comparator: traditionnal arm: Weight-based dosing

Countries: France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Nice, France, France