Trials Sponsors Conditions Drugs Pricing

Conditions

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (1)

Relapse-free survival in both groups (immediate vs. gradual discontinuation) at 26 weeks of follow-up, defined as the time from S0 (start of immediate/progressive discontinuation strategy) to relapse or death (any cause), whichever occurs first.

Secondary Outcomes (6)

1. Relapse-free survival in both groups (immediate vs. gradual discontinuation) at W52 and W78 - 2. Cumulative prednisone dose at W26, W52 and W78 - 3. Quality of life scores (HAQ, SF-36) at W0, W12, W26, W52 and W78 - 4. FACIT-Fatigue score at W0, W12, W26, W52 and W78 - 5. Percentage of patients in remission without prednisone at W26, W52 and W78 - 6. Percentage of patients in remission with prednisone dose ≤5 mg/day at W26, W52 and W78
Factors associated with relapse-free survival at 26, 52, 78 weeks of follow-up. Potential relapse factors will include all relevant variables such as demographic, clinical and biological data related to GCA (gender, age, large vessel involvement, CRP, fibrinogen, IL-6), duration of TCZ treatment before inclusion, relapse status before inclusion.
Frequency and type of adverse events in both groups during the first 78 weeks after inclusion
Frequency of corticosteroid-related side effects (GTI score [Appendix 1] at baseline and at 52 weeks) in both groups
Immunomonitoring : a.Serum concentrations of haptoglobin, orosomucoid, CXCL10, IFN-γ, GM-CSF, IL-6, soluble IL-6R, and soluble gp130 measured by Luminex® at W0, W12, W26, and W52, and at relapse. - b. Percentage of Th1 (CD4+ IFN-γ+), Th17 (CD4+ IL-17+) and Treg (CD4+ CD25high FoxP3+) cells among total CD4+ T cells and expression levels of IL-6R and Gp130 by CD4+ T cells, measured by flow cytometry at W0, W12 and W26 and in case of relapse (limited to 5 centers: Dijon, Mâcon, Cochin, Metz, Nancy)
+1 more secondary outcomes

Interventions

RoActemra 162 mg solution for injection in pre-filled syringe.Type not reported

RoActemra 162 mg solution for injection in pre-filled pen.Type not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
RoActemra 162 mg solution for injection in pre-filled syringe.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
RoActemra 162 mg solution for injection in pre-filled pen.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

RoActemra 162 mg solution for injection in pre-filled syringe.
Named ingredient: tocilizumab
View registry record
RoActemra 162 mg solution for injection in pre-filled pen.
Named ingredient: tocilizumab
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written consent
Diagnosis of GCA, defined by the following criteria: Age ≥50 years at diagnosis
Diagnosis of GCA, defined by the following criteria: History of ESR ≥50 mm/h OR CRP ≥20 mg/L (optional criterion if temporal artery biopsy (TAB) is positive).

Sponsors & Collaborators

Centre Hospitalier Universitaire De Dijon
Type not reportedlead

Study Sites (43)

Assistance Publique Hopitaux De Marseille

Marseille, 13005, France

Mikael EBBO0491388823 mikael.ebbo@aphm.fr

University Hospital Of Clermont-Ferrand

Clermont Ferrand Cedex 1, 63003, France

Marc ANDRE0473751435 mandre@chu-clermontferrand.fr

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble Cedex 9, 38043, France

Laurence BOUILLET0476765565

Central Study Contacts

chef de projets recherche

0380295578 DRCIDijon.UPI@chu-dijon.fr

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

May 16, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-505515-21-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 03:48:05 UTC

Documents

D1_Protocol 2023-505515-21-00- for publication

TocilizuMab discontinuAtion in GIant Cell Arteritis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (43)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (43)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations