NCT01002781

Efficacy and Safety of Tocilizumab in Adult's Still Disease

Efficacy and Safety of Tocilizumab (a Monoclonal Antibody to Receptor of IL-6) in the Treatment of Adult's Still Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Adult's Still Disease

Interventions

Type	Name	Description
DRUG	Tocilizumab	Tocilizumab, IV, 8 mg/kg, every 2 weeks

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-10-27
• Last updated: 2009-10-27

Locations

4 sites across 1 country: Israel