Clinical Trial: Efficacy and Safety of Tocilizumab in Adult's Still Disease
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Efficacy and Safety of Tocilizumab (a Monoclonal Antibody to Receptor of IL-6) in the Treatment of Adult's Still Disease
Brief Summary: 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.
Detailed Summary:
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
Sponsor: Tel-Aviv Sourasky Medical Center
Current Primary Outcome: symptom-free or steroid-free remission at 52 weeks [ Time Frame: 52 WEEKS ]
Original Primary Outcome: Same as current
Current Secondary Outcome: fever, ACR20, inflammatory markers (e.g. CRP, ferritin), need for rescue medication (e.g. methotrexate, anti-TNF alpha) , adverse events [ Time Frame: 52 weeks ]
Original Secondary Outcome: Same as current
Information By: Tel-Aviv Sourasky Medical Center
Dates:
Date Received: October 26, 2009
Date Started: November 2009
Date Completion: July 2011
Last Updated: October 26, 2009
Last Verified: September 2009
