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Can we stop this arthritis drug without relapse? new trial aims to find out

NCT ID NCT06037460

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at the best way to stop tocilizumab in people with giant cell arteritis, a type of blood vessel inflammation. About 120 participants will either stop the drug suddenly or taper it slowly over time. The goal is to see which approach leads to fewer relapses and allows patients to use less steroids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tocilizumab
What this could lead to
If successful, this could provide a safe way to stop tocilizumab without increasing relapse risk, reducing treatment burden and side effects for patients with giant cell arteritis.
What could go wrong
This is a phase 3 trial but only tests discontinuation strategies, not a new treatment. Relapse risk after stopping tocilizumab is known to be around 40%, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

120 people

The number who actually took part.

Started

May 2024

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

51 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written consent * Diagnosis of GCA, defined by the following criteria: * Age ≥50 years at diagnosis * AND History of ESR ≥50 mm/h OR CRP ≥20 mg/L (optional criterion if temporal artery biopsy (TAB) is positive). * AND at least one of the following clinical criteria: * At least one unequivocal sign of GCA (recent headache, scalp hyperesthesia, jaw claudication, temporal artery abnormality, visual disturbances of ischemic origin) * Clinical sign(s) of polymyalgia rheumatica (PR) * AND at least one of the following criteria during GCA follow-up: * TAB consistent with the diagnosis of GCA (non-necrotizing vasculitis with a mononuclear cell-rich inflammatory infiltrate or presence of granulomas, with or without multinuclear giant cells) * Evidence of temporal artery vasculitis by echo-Doppler of the temporal arteries (unilateral or bilateral halo sign) * Evidence of vasculitis of at least one large vessel by imaging: * angio-CT or angio-MRI: arterial wall thickening (≥2mm for aorta; ≥1mm for supra-aortic trunks and upper extremity arteries, ≥0.6mm for the cephalic artery, …) and/or T1-weighted contrast. * PET: grade 2 or 3\* hypermetabolism of the wall of at least one large vessel (aorta, supra-aortic trunks, cephalic vessels, upper extremity arteries) (\*i.e., arterial SUVmax ≥ liver SUVmax) * GCA in remission for at least 12 weeks before randomisation (remission = absence of symptoms due to GCA AND CRP ≤10 mg/L) * TCZ treatment (IV or SC) or biosimilar initiated 12 to 36 months prior to randomization * TCZ treatment (IV or SC) or biosimilar not interrupted more than 12 weeks in the 12 months prior to randomization * Treatment with subcutaneous TCZ (162 mg/week) or biosimilar for at least 12 consecutive weeks prior to randomization * Treatment with corticoids stopped at least 12 weeks before randomization (hydrocortisone treatment ≤20 mg/day is possible if given at a stable dose for the duration of the study) * Biological workup dating from less than 6 weeks on the day of randomization, showing good tolerance of tocilizumab: * AST and ALT \< 1.5 x upper limit of normal (ULN) * Hemoglobin \>8 g/dL * Platelets \>100 G/L * Neutrophils \>1 G/L * Lymphocytes \>0.5 G/L Exclusion Criteria: * Person who is not affiliated with the national health insurance system * Person subject to a measure of legal protection (guardianship, tutorship) * Person subject to a court order * Patient unable to give consent * Person who does not speak French * Pre-menopausal women (menopause = amenorrhea of more than 12 consecutive months) * Uncontrolled psychotic state * History of drug or alcohol intoxication requiring hospitalization within 12 months prior to randomization * Recent or scheduled surgery within 6 months of randomization * History of organ or hematopoietic marrow transplantation (except corneal transplantation performed at least 12 weeks prior to randomization) * Primary or secondary immune deficiency * Concomitant treatment with any of the following: * Methotrexate, leflunomide, cyclosporin A, azathioprine, mycophenolate mofetil, Janus kinase inhibitors, abatacept, secukinumab, anti-TNF-α, anakinra, ustekinumab, or any other immunosuppressive drug within 12 weeks prior to randomization * Rituximab or other anti-CD20 agent within 1 year prior to randomization * Cyclophosphamide in the year prior to randomization * History of long-term corticosteroid therapy for conditions other than GCA or PPR. (NB: dermocorticoids, inhaled corticosteroids, and corticosteroid joint infiltrations are allowed during the study) * Patient who has previously received ≥3 courses of oral corticosteroids for a disease other than GCA or RRP within 6 months prior to randomization * Ongoing anti-tuberculosis treatment at the time of randomization * Infections: * Current viral hepatitis B or C * Ongoing HIV infection * Severe infection requiring hospitalization within 30 days prior to randomization * Any unstable or poorly controlled condition or disease, acute or chronic, not related to GCA, and considered a contraindication to tocilizumab therapy in the opinion of the investigator * Neoplasia \< 5 years, (except cervical cancer in situ and skin carcinoma, except melanoma, with R0 resection)

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Conditions

The condition(s) this trial relates to.

Giant Cell Arteritis temporal arteritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Chu Dijon Bourgogne

    Dijon, 21000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.