Randomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean fever
- Conditions
- familial Mediterranean fever
- Registration Number
- JPRN-UMIN000028010
- Lead Sponsor
- Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 23
Not provided
Patients applicable to even one of the following are excluded from the subject (1) Women who are breast-feeding, pregnant, or may become pregnant (2) Patients who have obvious infection within 4 weeks before the study and judged inappropriate by investigator or clinical trial doctor (3) Patients with a history of hypersensitivity to the components of tocilizumab (4) Patients who are recently being treated with biologics. (5) Patients with past history of tocilizumab (6) Patients who are routinely using corticosteroids (excluding topical therapy such as external preparations) due to diseases other than familial Mediterranean fever and whose investigator or clinical trial doctor judged inappropriate (7) Investigational drugs Patients falling under any of the following criteria for examination within one week prior to initial administration 1) Leukocyte count less than 3500 / microL 2) neutrophil count less than 1000 / microL 3) Lymphocyte count less than 500 / microL 4) Number of platelets less than 100000 / microL (8) Patients with active tuberculosis (9) Patients with a history of intestinal perforation (10) Patients who have interstitial pneumonia and who are judged inappropriate by investigators or clinical trial doctors (11) Patient diagnosed as having a malignant tumor within 5 years before the study. (12) Patients with active type B or C hepatitis or patients with a history of hepatitis B (13) Patients who have complicated serious diseases and who are judged inappropriate by investigators or clinical trial doctors as clinical trials (14) Patients inoculated with a live vaccine within 6 weeks before the study (15) Patients who are using other investigational drugs within 6 months before the initial investigational drug (16)Patients judged inappropriate by investigators or clinical trial doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of fever attacks (up to 4 times) at 24 weeks
- Secondary Outcome Measures
Name Time Method [Efficacy (at 24 weeks)] (1) Number of occurrences of accompanying symptoms during attacks (2) Time until fever attack occurs (3) Duration of fever attack (4) serum CRP, SAA (5) SF-36 Health Survey Questionnaire (6) General evaluation by doctor (100 mm VAS) (7) Body temperature (8) Percentage of achievement of FMF 50 at 12 weeks and 24 weeks [Safety] Adverse event [PK] Serum Tocilizumab level, CRP, ESR, sIL-6 receptor