Tdose Binding and Tocilizumab | NCT07582185

Studies
Tdose Binding and Tocilizumab

NCT07582185

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Not yet recruiting

Last Update Posted

May 12, 2026Actual

Enrollment

122Estimated

Phase

Phase 4

Conditions

Rheumatoid Arthritis

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2025-522319-41-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Sep 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

May 6, 2026

First Submission Date that Met QC Criteria

May 6, 2026

First Posted Date

May 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2026

Last Update Posted Date

May 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Experimental: dose binding arm	Drug	TOCILIZUMAB administered at standardized, fixed-interval doses versus weight-based dosing	dose binding arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease activity	DAS28 (0 to 28)	month 3

Secondary Outcomes

Measure	Description	Time Frame
cost	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.	month 3

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian ROUX, Professor	Contact	0492035477		roux.c2@chu-nice.fr

Overall Officials

Name	Affiliation	Role
Christian ROUX, Doctor	Centre Hospitalier Universitaire de Nice	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nice		Nice	France	06000	France

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

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Browse Branches

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