Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement

NCT04888221 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: APHP1910622020-000080-23
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

A French multicenter randomised and placebo-controlled study recruiting patients who present neurovascular involvement related to GCA (\> 60 years) with symptomatic (stroke) or asymptomatic forms. The aim of this study is to assess the efficacy of tocilizumab to induce complete remission of GCA with cerebrovascular involvement (clinical and biological) and absence of clinical and MRI ischemic stroke recurrence at 24 weeks.

Conditions

Giant Cell Arteritis; Neurovascular Disorder

Keywords

Giant Cell Arteritis; ischemic complication/ ischemic event; Cerebro-vascular involvement; Steroids; Tocilizumab; Horton's Giant Cell Arteritis; Vascular Diseases; Neurovascular Diseases; Cerebrovascular Disorders

Outcome Measures

Primary Outcomes (1)

• Percentage of patients in complete remission of GCA with absence of ischemic stroke recurrence at 24 weeks under tocilizumab.

  Percentage of participants with complete remission of GCA, defined as an absence of clinical signs of GCA, a CRP levels less than 10 mg/l and an absence of new ischemic stroke signs at MRI realized at 24 weeks after the tocilizumab initiation

  From date of treatment initiation until 24 weeks.

Secondary Outcomes (8)

• Compare within tocilizumab and placebo groups the percentage of clinical and MRI ischemic stroke recurrence at 24 weeks

  at week 4, 12, 24 and 52.

• The relapse-free survival

  up to 52 weeks

• Compare within tocilizumab and placebo groups the time to remission in patients with GCA during 52 weeks.

  at week 4, 12, 24 and 52.

• Compare within tocilizumab and placebo groups the improvement of neurovascular radiological involvement during 52 weeks

  at week 4, 12, 24 and 52.

• Compare within tocilizumab and placebo groups the steroid sparing effect at 24 weeks

  up to 24 weeks

Study Arms (2)

tocilizumab 162mg/0.9mL administered subcutaneously (SC) weekly during 24 weeks

EXPERIMENTAL

Tocilizumab 162mg/0.9mL administered subcutaneously (SC) weekly during 24 weeks

Drug: Tocilizumab

placebo administered subcutaneously (SC) weekly during 24 weeks

PLACEBO COMPARATOR

Placebo administered subcutaneously (SC) weekly during 24 weeks

Drug: Placebo

Interventions

Tocilizumab DRUG

Tocilizumab will be administered subcutaneously at a dose of 162mg/0.9mL weekly (each week, on the same day) from week 0 to week 24. At the first injection (Baseline D0), a therapeutic education is provided for patients/caregivers who can carry out the injections themselves as part of their usual care.

Also known as: RoActemra, Actemra

tocilizumab 162mg/0.9mL administered subcutaneously (SC) weekly during 24 weeks

Placebo DRUG

Placebo administered subcutaneously (SC) weekly during 24 weeks

placebo administered subcutaneously (SC) weekly during 24 weeks

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 60 years
• Diagnosis of
• GCA (according to ACR criteria or positive temporal artery biopsy) (de novo and/or relapse) And neurovascular involvement:
• Either Ischemic stroke (including TIA) in the vertebro-basilar or carotid territory (symptomatic arterial involvement)
• Either PET uptake of vertebral and/or carotid arteries (extra or intra cranial) and/or angioCT or angioMRI showing arterial involvement consistent with vasculitis (asymptomatic arterial involvement)
• within 4 weeks after the stroke concerning the "symptomatic" patients
• within 4 weeks after the diagnosis of GCA (or relapse) concerning the patients with asymptomatic neurovascular involvement.
• Within 21 days after starting the corticosteroids
• Signed Informed Consent Form
• Affiliation to social security

You may not qualify if:

• Other proven cause of stroke: atrial fibrillation, significant atheromatous stenosis of carotid or vertebro-basilar arteries
• Contraindication to and precaution in use of tocilizumab:
• Treatment with any investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever was longer) of screening
• Previous treatment with cell-depleting therapies, including investigational agents,including but not limited to Campath (alemtuzumab), anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20 within 6 months before the baseline
• Treatment with IV gamma globulin or plasmapheresis within 24 weeks of baseline
• Previous treatment with alkylating agents, such as chlorambucil, or with total lymphoid irradiation within 2 months before the baseline
• Previous treatment with TCZ within 6 months before the baseline
• Immunization with a live/attenuated vaccine within 4 weeks prior to baseline or simultaneously with tocilizumab treatment
• Treatment with hydroxychloroquine, cyclosporine A, azathioprine, or mycophenolate mofetil (MMF) within 4 weeks of baseline
• Treatment with etanercept within 2 weeks; infliximab, certolizumab, golimumab,abatacept, or adalimumab within 8 weeks; or anakinra within 1 week of baseline
• Previous treatment with tofacitinib within 2 months before the baseline
• Treatment with cyclophosphamide within 24 weeks of baseline
• History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or to prednisone
• Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), psychiatric, osteoporosis/osteomalacia, glaucoma, corneal ulcers/injuries, or gastrointestinal disease
• Current liver disease, as determined by the investigator

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Roche Chugai: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

Saint Antoine Hospital, Neurology Unit, Assistance Publique-Hôpitaux de Paris

Paris, 75012, France

Location

MeSH Terms

Conditions

Giant Cell Arteritis; Vascular Diseases; Cerebrovascular Disorders

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sonia ALAMOWITCH, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: May 17, 2021
• Study Start: September 24, 2021
• Primary Completion: January 29, 2025
• Study Completion: August 13, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

FR (1)