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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000028010 |
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Date of registration:
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07/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Randomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean fever
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Scientific title:
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Randomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean fever - Clinical trial of Tocilizumab for colchicine-resistant familial Mediterranean fever |
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Date of first enrolment:
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2018/03/01 |
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Target sample size:
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24 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032030 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kawakami
Atsushi |
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Address:
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Sakamoto 1-7-1, Nagasaki
Japan |
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Telephone:
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095-819-7260 |
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Email:
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atsushik@nagasaki-u.ac.jp |
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Affiliation:
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Nagasaki University Graduate School of Biomedical Sciences Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences |
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Name:
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Kawakami
Atsushi |
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Address:
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Sakamoto 1-7-1, Nagasaki
8528501
Japan |
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Telephone:
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095-819-7260 |
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Email:
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atsushik@nagasaki-u.ac.jp |
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Affiliation:
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Nagasaki University Graduate School of Biomedical Sciences Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion 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
Age minimum:
12years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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familial Mediterranean fever
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Intervention(s)
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Tocilizumab
Placebo
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Primary Outcome(s)
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Number of fever attacks (up to 4 times) at 24 weeks
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Secondary Outcome(s)
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[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
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Source(s) of Monetary Support
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Japan Agency for Medical Research and Development
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Ethics review
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Status: YES
Approval date: 28/09/2018
Contact:
2745@ml.nagasaki-u.ac.jp
Institutional Review Board, Nagasaki University Hospital
095-819-7256
2745@ml.nagasaki-u.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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10/12/2019 |
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URL:
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