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Giant Cell ArteritisPhase 3TOGIACNCT04888221

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

A Phase 3 study testing Tocilizumab in people with Giant Cell Arteritis and Neurovascular Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Giant Cell Arteritis, Neurovascular Disorder
What is being tested?
Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteFrance
Study dates
24 Sep 2021to 13 Aug 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 37Show fewer
  • 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
  • History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose a patient to perforations
  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
  • Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
  • Active TB requiring treatment within the previous 3 years
  • Patients treated for TB with no recurrence within 3 years and patients treated for latent TB within 3 years were eligible.
  • Primary or secondary immunodeficiency (history of or currently active)
  • Evidence of malignant disease or malignancies diagnosed within the previous 5 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that had been excised and cured)
  • History of alcohol, drug, or chemical abuse within 1 year prior to screening
  • Body weight >150 kg
  • Serum creatinine >1.4 mg/dL (124 µmol/L) in female patients and 1.6 mg/dL (141 µmol/L) in male patients
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)× 3 Upper limit of normal (ULN)>
  • Platelet count < 100 109/L (100,000/mm3)
  • Hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)
  • White blood cells <3.0 x109/L (3000/mm3)
  • Absolute neutrophil count < 2.0 x 109/L (2000/mm3)
  • Absolute lymphocyte count < 0.5 X 109/L (500/mm3)
  • Positive hepatitis B surface antigen or hepatitis C antibody
  • Contraindication to aspirin, clopidogrel, steroids use, rifampicin and/or isoniazid
  • Major surgery within 8 weeks prior to screening or planned major surgery within 12 months after randomization, except arterial thrombectomy if necessary for ischemic stroke
  • Transplanted organs (except corneal transplant performed more than 3 months prior to screening)
  • Inability to provide informed consent
  • Participation in another interventional research

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Paris, 75012

Other trials in France

About this study

Official title: Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement (ToGiAC)

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.

Read the detailed description

Giant cell arteritis (GCA) in the elderly is considered a medical emergency in case of ischemic complication, urgent treatment is needed and high doses of intravenous steroids are used. To date, usual treatments added to steroids have not been shown to be effective in reducing the risk of ischemic event recurrence in GCA.

Recently, the efficacy of tocilizumab has been demonstrated as a steroid-sparing agent and a long-term complete remission agent. The aim of this study is to address the potential benefits of tocilizumab as induction therapy in combination with high dose steroids to improve the neurovascular involvement in GCA.

The study will enroll 66 subjects with GCA (according to ACR criteria or positive temporal artery biopsy) and neurovascular involvement (symptomatic or asymptomatic). It consist of a screening phase (up to 30 days), a baseline/randomization phase and a treatment phase with experimental treatment or placebo (weekly administrated) which could be combined with usual treatments for stroke as antiaggregants and/or anticoagulants (24 weeks). Regular visit will be performed to follow the GCA remission, adverse treatments effects and proceed to radiological and biological evaluations (visit assessment at weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36) until end of study visit at week 52.

Being tested
Tocilizumab, Placebo
Keywords
Giant Cell Arteritis, ischemic complication/ ischemic event, Cerebro-vascular involvement, Steroids, Tocilizumab, Horton's Giant Cell Arteritis, Vascular Diseases, Neurovascular Diseases, Cerebrovascular Disorders
Medical subject headings
Giant Cell Arteritis, Vascular Diseases, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

    Also called RoActemra, Actemra

    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.

  • PlaceboDrug

    Placebo administered subcutaneously (SC) weekly during 24 weeks

Study groups in NCT04888221
Study groupRoleWhat they receive
tocilizumab 162mg/0.9mL administered subcutaneously (SC) weekly during 24 weeksExperimentalTocilizumab 162mg/0.9mL administered subcutaneously (SC) weekly during 24 weeks
Receives: Drug: Tocilizumab
placebo administered subcutaneously (SC) weekly during 24 weeksPlacebo comparatorPlacebo administered subcutaneously (SC) weekly during 24 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From date of treatment initiation until 24 weeks.

Secondary outcomes (8)

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

    the efficacy of weekly tocilizumab on the prevention of stroke recurrence will be measured by the percentage of stroke recurrence compared to control group in patients with GCA during 52 weeks at week 4, 12, 24 and 52

    Measured: at week 4, 12, 24 and 52.

  2. The relapse-free survival

    Number of patients who had relapsed as defined as major if clinical symptoms are present, or as minor in the case of isolated acute pase reactants increase

    Measured: up to 52 weeks

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

    the time to remission will be assessed in comparison with the control group in patients with GCA during 52 weeks at week 4, 12, 24 and 52 Number of days between treatment induction and signs of remission.

    Measured: at week 4, 12, 24 and 52.

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

    Proportion of patient with neurovascular radiological involvement defined as angio-CT improvement of vasculitis lesions and /or improvement or disappearance of PET FDG uptake.

    Measured: at week 4, 12, 24 and 52.

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

    Cumulative steroid dose at 24 weeks

    Measured: up to 24 weeks

  6. Mortality at week 4, 12, 24 and 52

    Percentages of deaths at week 4, 12, 24 and 52.

    Measured: at week 4, 12, 24 and 52

  7. Evolution of degree of disability or dependence at week 4, 12, 24 and 52

    Percentages of patients with rankin score 0-1

    Measured: at week 4, 12, 24 and 52.

  8. Percentage of Participants with Adverse Events/ serious adverse events

    Percentage of participants with adverse events, treatment-related adverse events or serious adverse event as assessed by CTCAE v4.0, at week 4, 12, 24 and 52

    Measured: at week 4, 12, 24 and 52.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2021
  2. Study start24 Sep 2021
  3. Primary completion29 Jan 2025
  4. Study completion13 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04888221
Sponsor's protocol ID
APHP191062
Other IDs
2020-000080-23
Acronym
TOGIAC
Status last verified
Jun 2025
First submitted
25 Mar 2021
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tocilizumab in people with Giant Cell Arteritis and Neurovascular Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients in complete remission of GCA with absence of ischemic stroke recurrence at 24 weeks under tocilizumab. (time frame: From date of treatment initiation until 24 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04888221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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