BridgeMD
Efficacy of Tocilizumab in association to steroids in giant cell arteritis with cerebro-vascular involvement patients (ToGiAS). A french prospective multicentre randomized versus placebo phase III trial (TOGIAC)
EU CTIS ID: 2024-511906-21-00
What this study is testing
Assess the efficacy of tocilizumab to induce complete remission of GCA with cerebrovascular involvement (clinical, radiological) and absence of clinical and MRI ischemic stroke recurrence at 24 weeks.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 60 years
- Diagnosis of : - GCA (according to ACR criteria or positive temporal artery biopsy) (de novo and/or relapse) - And neurovascular involvement: Defined by PET uptake of vertebral and/or carotid arteries (extra or intra cranial) or angioCT/MRI showing arterial involvement inconsistent with atherosclerosis Either Ischemic stroke (including TIA) in the vertebro-basilar or carotid territory (symptomatic arterial involvement) Without Ischemic stroke (including TIA) (asymptomatic arterial involvement)
- Inclusion should be done 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 likely can't join if
- Other proven cause of stroke: atrial fibrillation, significant atheromatous stenosis of carotid or vertebro-basilar arteries
- 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
- 13. 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
See the full eligibility criteria
Who can join
- Age > 60 years
- Diagnosis of : - GCA (according to ACR criteria or positive temporal artery biopsy) (de novo and/or relapse) - And neurovascular involvement: Defined by PET uptake of vertebral and/or carotid arteries (extra or intra cranial) or angioCT/MRI showing arterial involvement inconsistent with atherosclerosis Either Ischemic stroke (including TIA) in the vertebro-basilar or carotid territory (symptomatic arterial involvement) Without Ischemic stroke (including TIA) (asymptomatic arterial involvement)
- Inclusion should be done 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
What rules you out
- Other proven cause of stroke: atrial fibrillation, significant atheromatous stenosis of carotid or vertebro-basilar arteries
- 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
- 13. 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)
- Treatment with any investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever was longer) of screening
- 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)
- 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
- Positive hepatitis B surface antigen or hepatitis C antibody
- Contraindication to aspirin, clopidogrel, steroids use, rifampicin and/or izoniazid
- 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
- 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 tocilizumab (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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.