Unique ID issued by UMIN | UMIN000032557 |
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Receipt number | R000037116 |
Scientific Title | An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance |
Date of disclosure of the study information | 2018/05/30 |
Last modified on | 2021/05/12 10:10:02 |
An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance
An open-label continuation trial of tocilizumab for familial Mediterranean fever
An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance
An open-label continuation trial of tocilizumab for familial Mediterranean fever
Japan |
familial Mediterranean fever
Clinical immunology | Pediatrics |
Others
YES
To assess the long-term safety of Tocilizumab in FMF patients
Safety
Safety
Adverse event
Efficacy
Number of fever attacks
Interventional
expanded access
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Tocilizumab
12 | years-old | <= |
Not applicable |
Male and Female
(1) Patients who completed the 24-week study drug administration period of the preceding trial.
(2) 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.
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 with a history of hypersensitivity to the components of tocilizumab
(3) Patients whose corticosteroids are routinely used (excluding topical treatments such as external preparations) due to diseases other than familial Mediterranean fever and which are judged inappropriate by investigators or clinical trial doctors
(4) Patients who have interstitial pneumonia and who are judged inappropriate by investigators or clinical trial doctors
(5) Patients who have complicated serious diseases and who are judged inappropriate by investigators or clinical trial doctors as clinical trials
(6) Patients whose investigator or clinical trial doctor judged that the condition in the preceding study is inappropriate for continued administration
(7) Patients judged inappropriate by investigators or clinical trial doctors
24
1st name | Atsushi |
Middle name | |
Last name | Kawakami |
Nagasaki University Graduate School of Biomedical Sciences
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences
8528501
Sakamoto 1-7-1, Nagasaki
095-819-7260
atsushik@nagasaki-u.ac.jp
1st name | Tomohiro |
Middle name | |
Last name | Koga |
Nagasaki University Graduate School of Biomedical Sciences
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences
8528501
Sakamoto 1-7-1, Nagasaki
095-819-7260
tkoga@nagasaki-u.ac.jp
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
Japan Agency for Medical Research and Development
Japanese Governmental office
CHUGAI PHARMACEUTICAL CO., LTD.
Institutional Review Board, Nagasaki University Hospital
1-7-1 Sakamoto, Nagasaki 852-8501
095-819-7256
2745@ml.nagasaki-u.ac.jp
NO
長崎大学病院(長崎県)、千葉大学医学部附属病院(千葉県)、福島県立医科大学附属病院(福島県)、九州大学病院(福岡県)、京都大学医学部附属病院(京都府)、金沢大学附属病院(金沢県)、信州大学医学部附属病院(長野県)、横浜市立大学附属病院(神奈川県)、北海道大学病院(北海道)
2018 | Year | 05 | Month | 30 | Day |
Unpublished
Completed
2018 | Year | 05 | Month | 30 | Day |
2018 | Year | 05 | Month | 31 | Day |
2018 | Year | 09 | Month | 01 | Day |
2021 | Year | 02 | Month | 19 | Day |
2021 | Year | 04 | Month | 30 | Day |
2021 | Year | 05 | Month | 06 | Day |
2021 | Year | 07 | Month | 28 | Day |
The manuscript title
An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance : Study protocol for investigator-initiated, multicenter, open-label trial
The authorship list in the study protocol
Tomohiro Koga, MD, PhD, Naoko Hagimori, PhD, Shuntaro Sato, PhD, Shinpei Morimoto, PhD, Naoki Hosogaya, MD, PhD, Chizu Fukushima, MD, PhD, Hiroshi Yamamoto, Atsushi Kawakami, MD, PhD
2018 | Year | 05 | Month | 11 | Day |
2021 | Year | 05 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037116
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