Status:
RECRUITING
TocilizuMab discontinuAtion in GIant Cell Arteritis
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Giant Cell Arteritis
Eligibility:
All Genders
51+ years
Phase:
PHASE3
Brief Summary
Giant cell arteritis (GCA) is a large-vessel vasculitis that typically occurs in people over the age of 50. Corticosteroids (GC) are the cornerstone of treatment for GCA. French guidelines recommend ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06037460
Start Date
May 13 2024
End Date
November 1 2028
Last Update
November 21 2025
Active Locations (1)
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1
Chu Dijon Bourgogne
Dijon, France, 21000