UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032557
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

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Basic information

Public title

An open-label continuation trial of tocilizumab for familial Mediterranean fever 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 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


Not applicable

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 Atsushi
Middle name
Last name Kawakami

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences

Zip code

8528501

Address

Sakamoto 1-7-1, Nagasaki

TEL

095-819-7260

Email

atsushik@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Tomohiro
Middle name
Last name Koga

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences

Zip code

8528501

Address

Sakamoto 1-7-1, Nagasaki

TEL

095-819-7260

Homepage URL


Email

tkoga@nagasaki-u.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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

Institutional Review Board, Nagasaki University Hospital

Address

1-7-1 Sakamoto, Nagasaki 852-8501

Tel

095-819-7256

Email

2745@ml.nagasaki-u.ac.jp


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

Completed

Date of protocol fixation

2018 Year 05 Month 30 Day

Date of IRB

2018 Year 05 Month 31 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2021 Year 02 Month 19 Day

Date of closure to data entry

2021 Year 04 Month 30 Day

Date trial data considered complete

2021 Year 05 Month 06 Day

Date analysis concluded

2021 Year 07 Month 28 Day


Other

Other related information

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


Management information

Registered date

2018 Year 05 Month 11 Day

Last modified on

2021 Year 05 Month 12 Day



Link to view the page

Value
https://center6.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