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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032557
Receipt No. R000037116
Scientific Title An open-label continuation trial of tocilizumab for familial Mediterranean fever (FMF) with colchicine ineffective or intolerance
Date of disclosure of the study information 2018/05/30
Last modified on 2019/02/06

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Basic information
Public title An open-label continuation trial of tocilizumab for familial Mediterranean fever (FMF) with colchicine ineffective or intolerance
Acronym An open-label continuation trial of tocilizumab for familial Mediterranean fever
Scientific Title An open-label continuation trial of tocilizumab for familial Mediterranean fever (FMF) with colchicine ineffective or intolerance
Scientific Title:Acronym An open-label continuation trial of tocilizumab for familial Mediterranean fever
Region
Japan

Condition
Condition familial Mediterranean fever
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To assess the long-term safety of Tocilizumab in FMF patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Adverse event
Key secondary outcomes Efficacy
Number of fever attacks

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tocilizumab
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
12 years-old <=
Age-upper limit
76 years-old >=
Gender Male and Female
Key inclusion criteria (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.
Key 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 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
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Kawakami
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences
Zip code
Address Sakamoto 1-7-1, Nagasaki
TEL 095-819-7260
Email atsushik@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Kawakami
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences
Zip code
Address Sakamoto 1-7-1, Nagasaki
TEL 095-819-7260
Homepage URL
Email nuh_fmf@ml.nagasaki-u.ac.jp

Sponsor
Institute Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) CHUGAI PHARMACEUTICAL CO., LTD.

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 11 Day
Last modified on
2019 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037116

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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