Tocilizumab for the Treatment of Familial Mediterranean Fever
- Sponsor
- University Hospital Tuebingen
- Study ID
- NCT03446209
- Phase
- PHASE2
- Status
- Completed
Conditions
- Familial Mediterranean Fever
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 64 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tocilizumab Infusion RoAcemtra (EU) — DRUGExperimental arm's patients will obtain TCZ intravenously once every 4 weeks for 28 weeks
- 0.9% physiological saline — DRUGExperimental 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.
Study Details
Adult patients with Familial Mediterranean Fever, who have active disease
Key Dates
- Start date
- Apr 23, 2018
- Status verified
- Apr 2019
- Primary completion
- Oct 30, 2020
- Completion
- Oct 30, 2020
Study Design
- Enrollment
- 30 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: TocilizumabTocilizumab Infusion RoAcemtra (EU) or Actemra (Rest of the world)
- Placebo Comparator: Placebo0,9% physiological Saline
Primary Outcome Measure
Efficacy: measured change of Physician's Global Assessment of disease activity (PGA) [ Time Frame: at week -4,0,4,8,12,16,20,24,28,32 ]