Tocilizumab for the Treatment of Familial Mediterranean Fever
NCT03446209 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2020-11-18
Summary
Adult patients with Familial Mediterranean Fever, who have active disease
Conditions
- Familial Mediterranean Fever
Interventions
- DRUG
-
Tocilizumab Infusion RoAcemtra (EU)
Experimental arm's patients will obtain TCZ intravenously once every 4 weeks for 28 weeks
- DRUG
-
0.9% physiological saline
Experimental arm's patients will obtain saline intravenously once every 4 weeks for 16 weeks. If necessary, patients will get "rescue medication" after week 16 to week 28.
Sponsors & Collaborators
-
University Hospital Tuebingen
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-23
- Primary Completion
- 2020-10-30
- Completion
- 2020-10-30
Countries
- Germany
Study Locations
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