NCT07582185

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for phase_4 rheumatoid-arthritis

Timeline
7mo left

Started Jun 2026

Shorter than P25 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 6, 2026

Last Update Submit

May 6, 2026

Conditions

Rheumatoid Arthritis

Keywords

remissionlow disease activitydose bindinghealth economicsRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • disease activity

    DAS28 (0 to 28)

    month 3

Secondary Outcomes (1)

  • cost

    month 3

Study Arms (2)

dose binding arm

EXPERIMENTAL

dose binding arm for tocilizumab

Drug: Experimental: dose binding arm

traditionnal arm

ACTIVE COMPARATOR

dose weight for tocilizumab

Drug: Active Comparator: traditionnal arm: Weight-based dosing

Interventions

Active Comparator: traditionnal arm: Weight-based dosingDRUG

standart administration; weight-based dosing

traditionnal arm
Experimental: dose binding armDRUG

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

dose binding arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France, 06000, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Christian ROUX, Doctor

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian ROUX, Professor

CONTACT

0492035477roux.c2@chu-nice.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
2 dosage of TCZ are given to the patient in the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: bicentric randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 12, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations

FR(1)