Takayasu Arteritis Clinical Trial
Official title:
A Prospective Observational Study of Infliximab Biosimilar in the Treatment of Takayasu's Arteritis Resistant to Corticosteroids and Conventional Immune-suppressive Treatments
Takayasu arteritis (TA) is a chronic inflammatory disease affecting large and medium caliber
arteries, particularly the aortic arch and its main branches. Clinical manifestations are
caused by the marked thickening of the wall of the involved vessels, resulting in lumen
narrowing and ischemia of the tributary districts. Therapy is based on the use of
corticosteroids, immunosuppressants, and biologic drugs including infliximab, a monoclonal
antibody blocking tissue necrosis factor (TNF)-alpha. Biosimilar infliximab is commercially
available and used in the treatment of various immune-mediated conditions. There are
currently no data on the efficacy and safety of biosimilar infliximab in the treatment of
TA.
The investigators propose this monocentric, observational, prospective, open label study to
evaluate the efficacy and safety of biosimilar infliximab in the treatment of 30 patients
with TA. Specifically, the study will include: I) TA patients refractory to treatment with
corticosteroid and/or immmunosuppressive therapy, not previously treated with infliximab;
II) TA patients already receiving treatment with originator infliximab.
Biosimilar infliximab will be administered at dosages usually employed in the treatment of
TA. Specifically, patients not previously treated with the originator drug will receive
biosimilar infliximab intravenously at a dose of 5 mg/Kg at time 0, at week 2, at week 4;
thereafter, treatment will be administered every 4-6 weeks at a dose of 5-10 mg/kg based on
clinical judgement. In patients previously treated with the originator drug, biosimilar
infliximab will be administered at the same dosages.
To evaluate the efficacy of therapy, changes in clinical manifestations, laboratory
examinations, and imaging findings including angio-magnetic resonance imaging (MRI) of
thoracic and abdominal vessels and total body PET/CT scan will be evaluate at time 0 as well
as 6 and 12 months following treatment initiation. In order to evaluate the safety of the
study treatment, the investigators will stringently evaluate possible side effects of
treatment, including infusion reactions, changes in laboratory tests, infection, cancer,
autoimmune manifestations, neurological and cardiovascular symptoms.
The total duration of follow up for each patient will be 52 weeks from enrolment.
n/a
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