Adult's Still Disease Clinical Trial
Official title:
Efficacy and Safety of Tocilizumab (a Monoclonal Antibody to Receptor of IL-6) in the Treatment of Adult's Still Disease
Patients with adult's Still disease suffer from acute inflammatory symptoms such as fever, arthritis, rash, and acute phase response often requiring high dose corticosteroids. In view of several case reports which have shown dramatic improvement in patients treated with Tocilizumab and a phase 2 study of this drug in children with Still's disease, the objective of the current study is to assess the efficacy and safety of Tocilizumab in patients with adult's Still disease.
This is a multicenter, open, study designed to investigate the effect of Tocilizumab, a
monoclonal antibody to IL-6 receptor, on the management of active adult-onset Still's
disease.
Standard medication of corticosteroid will be given to all patients at the discretion of the
treating physician.
Visits will include : screening visit, week o, week 2 , and every 4 weeks after during 52
weeks After complying with the inclusion and exclusion criteria, patients will start
treatment with Tocilizumab at a dosage of 8 mg/kg, every 2 weeks Patients will be assessed
every visit for the presence of fever, tender and swollen joint, rash, dosage of
corticosteroids and other DMARD's, CRP and ESR
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment