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Tocilizumab in Familial Mediterranean Fever
NCT03446209Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2018
- Primary completion
- Oct 2020
- Countries
- 1
- Sponsor
- University Hospital Tübingen
- Modality
- Antibody Conjugates, Recombinant Proteins and Enzymes, Engineered Antibody Formats
- Drugs
- tocilizumab
- Conditions
- Familial Mediterranean fever (FMF)
01
Overview
Phase 2, randomised, double-blind trial in Familial Mediterranean fever (FMF) comparing Tocilizumab with Placebo (2 arms). Primary endpoint: Physician's Global Assessment of disease activity at 32 weeks. Started Apr 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tocilizumab
Tocilizumab IV every 4 weeks
Placebo
Placebo IV every 4 weeks
03
Who it enrols
Adult patients with Familial Mediterranean Fever (FMF) according to Tel Hashomer Criteria with at least one MEFV mutation, who have active disease despite colchicine treatment or are intolerant to colchicine.
04
Endpoints
Primary
Physician's Global Assessment of disease activity
Secondary
Erythrocyte Sedimentation Rate
Serological remission
Serum Amyloid A
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