Evidence map›Paper›PMID 41067765›Full record

ArticleBMJ open2025

Immediate versus gradual Tocilizu

Maxime Samson, Isabelle Fournel, Abderrahmane Bourredjem, Marion Cortier, Emilie Galizzi, Amélie Cransac, Claudie Cladière, Camille Fleck, Marion Brayer, Maud Carpentier and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06037460 (TocilizuMab discontinuAtion in GIant Cell Arteritis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06037460 phase3active not recruitingnot on this map

TocilizuMab discontinuAtion in GIant Cell Arteritis

TypeinterventionalSponsorCentre Hospitalier Universitaire DijonRan2024 to 2028Enrolled120ConditionsGiant Cell ArteritisArmsTocilizumab treatment, questionnaires, Blood samples, 18FDG PET scan
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Maxime SamsonService de Médecine Interne et Immunologie Clinique, CHU Dijon Bourgogne, Université Bourgogne Europe, Centre de Référence Maladies Rares Maladies auto-immunes et autoinflammatoires systémiques rares, Dijon, France maxime.samson@chu-dijon.fr.ORCID http://orcid.org/0000-0002-6547-232X
Isabelle FournelCHU Dijon Bourgogne, Centre d'Investigation Clinique, module épidémiologie clinique, INSERM, CIC 1432, Université Bourgogne Europe, Dijon, France.ORCID http://orcid.org/0000-0002-3061-9715
Abderrahmane BourredjemCHU Dijon Bourgogne, Centre d'Investigation Clinique, module épidémiologie clinique, INSERM, CIC 1432, Université Bourgogne Europe, Dijon, France.
Marion CortierCHU Dijon Bourgogne, Direction de la Recherche Clinique et de l'Innovation, Université Bourgogne Europe, Dijon, France.
Emilie GalizziCHU Dijon Bourgogne, Centre d'Investigation Clinique, module épidémiologie clinique, INSERM, CIC 1432, Université Bourgogne Europe, Dijon, France.
Amélie CransacCHU Dijon Bourgogne, Pharmacie, Université Bourgogne Europe, Dijon, France.
Claudie CladièreService de Médecine Interne et Immunologie Clinique, CHU Dijon Bourgogne, Université Bourgogne Europe, Centre de Référence Maladies Rares Maladies auto-immunes et autoinflammatoires systémiques rares, Dijon, France.
Camille FleckCHU Dijon Bourgogne, Direction de la Recherche Clinique et de l'Innovation, Université Bourgogne Europe, Dijon, France.
Marion BrayerCHU Dijon Bourgogne, Direction de la Recherche Clinique et de l'Innovation, Université Bourgogne Europe, Dijon, France.
Maud CarpentierCHU Dijon Bourgogne, Direction de la Recherche Clinique et de l'Innovation, Université Bourgogne Europe, Dijon, France.
Jean-Louis AlberiniMédecine nucléaire, Centre Georges-Francois Leclerc, Dijon, France.
Hervé DevilliersCHU Dijon Bourgogne, Centre d'Investigation Clinique, module épidémiologie clinique, INSERM, CIC 1432, Université Bourgogne Europe, Dijon, France.
Bernard BonnotteService de Médecine Interne et Immunologie Clinique, CHU Dijon Bourgogne, Université Bourgogne Europe, Centre de Référence Maladies Rares Maladies auto-immunes et autoinflammatoires systémiques rares, Dijon, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGiant cell arteritis (GCA) is a large-vessel vasculitis occurring in people aged over 50 years. Recent studies have shown that tocilizumab (TCZ), an anti-IL-6 receptor monoclonal antibody, is remarkably effective in treating GCA and allows significant dose sparing of glucocorticoids. However, it makes it difficult to monitor disease activity. Furthermore, treatment is often prolonged over 1 year due to the fear of relapse after stopping TCZ and/or the absence of an optimal discontinuation scheme. METHODS AND ANALYSIS: This study aims at comparing two discontinuation regimens in a population of GCA patients who have been treated with TCZ for 12-36 months and have discontinued glucocorticoids for at least 12 weeks. Patients will be randomised with a 1:1 ratio between two arms: immediate discontinuation (cessation) versus gradual discontinuation of TCZ (162 mg subcutaneously every 2 weeks for 12 weeks and then every 4 weeks for 12 additional weeks). Patients will be followed up for 78 weeks. The primary endpoint is relapse-free survival after 26 weeks of follow-up. A total of 120 patients will be randomised (60 in each group) for a period of 3 years. ETHICS AND DISSEMINATION: The trial was approved by an independent ethics committee (CPP Sud Ouest et Outre Mer IV) and the French health authority (French National Agency for Medicines and Health Products Safety-ANSM) through the Clinical Trials Information System (CTIS) provided by the European Medicines Agency (EMA). The informed consent complies with the ICH GCP guideline and regulatory requirements. Eligible patients may only be included in the study after providing informed consent. Findings will be published in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT06037460.

Indexed as

Antibodies, Monoclonal, HumanizedGiant Cell ArteritisAgedClinical Trials, Phase III as TopicDrug Administration ScheduleFemaleGlucocorticoidsHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicAntibodies, Monoclonal, HumanizedGlucocorticoidstocilizumabClinical TrialINTERNAL MEDICINERandomized Controlled Trial

Identifiers

PMID41067765
PMCPMC12519690

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.