Efficacy and Safety of Tocilizumab in Adult's Still Disease

Sponsor
Tel-Aviv Sourasky Medical Center
Study ID
NCT01002781
Phase
PHASE2
Status
Unknown

Conditions

  • Adult's Still Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab, IV, 8 mg/kg, every 2 weeks

Study Details

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.

Key Dates

Start date
Nov 30, 2009
Status verified
Sep 2009
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

symptom-free or steroid-free remission at 52 weeks [ Time Frame: 52 WEEKS ]

Central Contacts