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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Tocilizumab, IV, 8 mg/kg, every 2 weeks
Bnei Tsion Medical Center
Haifa, Israel
Rambam Medical Center
Haifa, Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Assaf Harofe Medical Center
Ẕerifin, Israel
symptom-free or steroid-free remission at 52 weeks
Time frame: 52 WEEKS
fever, ACR20, inflammatory markers (e.g. CRP, ferritin), need for rescue medication (e.g. methotrexate, anti-TNF alpha) , adverse events
Time frame: 52 weeks
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