familial Mediterranean fever
Conditions
Interventions
Sponsors
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For patients who satisfy all the following conditions [Temporarily registered] Temporary registration is permitted when the target patient meets all the following criteria. (1) Patients diagnosed as familial Mediterranean fever (clinically typical) according to the following diagnostic criteria ("Regarding diagnostic criteria and severity classification related to designated intractable diseases" by the Ministry of Health, Labor and Welfare) (2) Patients with colchicine ineffective or colchicine inadequate (3) Patients who aged 12 to over 75 years old (regardless of gender) (4) Patients who got adequate explanation about the contents of explanatory documents and other matters concerning clinical trials, understand the contents thereof, and obtain written consent based on free will about participation in this trial [When randomized] When provisionally registered patient meets all the following criteria, it is randomly assignable. (1) Patients who had a fever attack (a fever that lasted more than 6 hours and had a fever over 38.0 during the observation period (2) Patients who could exclude diseases other than familial Mediterranean fever, which cause fever, such as infectious diseases (3) Patients whose fever attacks had disappeared during the observation period [Rescue transition] It allows for transition to rescue when the target patient meets all the following criteria. (1) Patients who received one or more investigational drugs in a double-blind period (2) Patients who have experienced more than four fever attacks since the start of the study drug administration. (3) Patients whose fever attacks of (2) had disappeared (4) Patients judged by investigators or clinical trial doctors to be appropriate from a safety point of view (5) Patients who got consent from subjects and substitutes (subjects under 20 years of age)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of fever attacks (up to 4 times) at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| [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 | — |
Countries
Japan
Contacts
Public ContactKawakami Atsushi
Nagasaki University Graduate School of Biomedical Sciences Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences
Outcome results
None listed