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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.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000022624
Date of registration:	06/06/2016
Prospective Registration:	Yes
Primary sponsor:	Kanazawa University Hospital
Public title:	Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD
Scientific title:	Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD - Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD
Date of first enrolment:	2016/07/01
Target sample size:	5
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026079
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Takashi Matsushita
Address:	13-1 takaramachi, kanazawa Japan
Telephone:	0762652343
Email:	t-matsushita@med.kanazawa-u.ac.jp
Affiliation:	Kanazawa University Hospital Dermatology

Name:	Kazuhiko Takehara
Address:	13-1 takaramachi, kanazawa Japan
Telephone:	0762652343
Email:	takehara@med.m.kanazawa-u.ac.jp
Affiliation:	Kanazawa University Hospital Dermatology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1.Patients with a history of shock or hypersensitivity to this drug. 2.Patients who are complicated by infectious diseases. 3.Patients with a history of myocardial infarction or unstable angina. 4.Patients with reduced severe bone marrow function. 5.Women who may be pregnant or pregnant. 6.Lactating women

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

The patients with systemic sclerosis or sclerodermatous chronic GVHD.

Intervention(s)

treatment with tocilizumab duration: 116 weeks dosage: 8mg/kg times: 6 times Frequency: every 4 weeks

Primary Outcome(s)

Evaluate skin score every 4 weeks after treatment(total 116 weeks).

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Kanazawa University Hospital

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date: 29/06/2018
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	29/06/2018
URL:

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