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NCT Number: NCT07582185

Tdose Binding and Tocilizumab

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Nice

Nice, France, 06000

Location contact

Christian ROUX, Professor

CONTACT

[email protected]

0492034702

Damien ROCHE, Doctor

PRINCIPAL_INVESTIGATOR

About this study

The investigators aim to evaluate the non-inferiority of dose-banding versus weight-based dosing of tocilizumab in patients with rheumatoid arthritis in remission or with low clinical activity, at 3 months of treatment. The secondary objectives are: To evaluate the economic benefit of dose-banding on the production of bags in the pharmacy (cost of preparing the bags), To compare the time to pharmaceutical release between the two groups, To compare the rate of bag reallocation between the two groups. This is a multicenter, prospective, randomized study evaluating the non-inferiority of administering standard doses of TOCILIZUMAB versus weight-based doses in patients with rheumatoid arthritis in remission or with low clinical activity. The patient and the clinical evaluator will be blinded. The pharmacy team performing the preparation will be open-label.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: dose binding arm

Drug

TOCILIZUMAB administered at standardized, fixed-interval doses versus weight-based dosing

Active Comparator: traditionnal arm: Weight-based dosing

Drug

standart administration; weight-based dosing

Primary outcomes

  1. disease activity

    Time frame: month 3

    DAS28 (0 to 28)

Secondary outcomes

  1. cost

    Time frame: month 3

    The cost of preparing the bags is estimated based on the preparation time, which is the sum of the time spent on sterilization, production, and bag distribution over the 3-month study period in each of the two groups. The total cost over the 3-month study period will then be divided by the number of infusions to be administered to calculate the cost per infusion in each group.

Study contacts

Contact information is provided by the study sponsor or research team.

Christian ROUX, Professor

CONTACT

[email protected]

0492035477

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Non-inferiority Study of TOCILIZUMAB Administered at Standardized, Fixed-interval Doses Versus Weight-based Dosing in Patients With Low-activity or Clinically Remitted Rheumatoid Arthritis.

Acronym: TCZ

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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