UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Acronym	Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Scientific Title	Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Scientific Title:Acronym	Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Region	Japan

Condition
Condition	Systemic sclerosis
Classification by specialty	Medicine in general Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the effect of tocilizumab on skin sclerosis in patients with systemic sclerosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sum of skin scores from 17 sites of the body (modified Rodnan total skin score)
Key secondary outcomes	Skin hardness, elasticity, and viscosity evaluate by Vesmter

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with systemic sclerosis with sever skin sclerosis 2)Over 6 modified Rodnan total skin score with skin sclerosis on fingers, dorsal hands, forearms, and upper arms; change of total skin score is within 20% during the screening period (two months) 3)No malignancy 4)From 20 years old to 80 years old 5)Agreement to contraception during the study period 6)Patients who are able to give consent in writing after reading the explanatory text
Key exclusion criteria	1)Patients who are administered the other biologics 2)Patients who have history of anaphylactic reactions to this drug 3)Patients who have HBV or who are under the septic condition 4)significant liver damage 5)significant renal damage 6)possibility of tuberculosis 7)pregnancy 8)breast-feeding 9)participating in other clinical trial within three months before the beginni ng of this trial 10)judged inappropriate for this study by the physicians
Target sample size	5

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yoshihito Shima
Organization	Osaka University Graduate School of Medicine
Division name	Dept. of Respiratory medicine, Allergy and Rheumatic diseases
Zip code
Address	2-2 Yamada-oka, Suita, 565-0871 Japan
TEL	06-6879-3833
Email	ryanjin@imed3.med.osaka-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Yoshihito Shima
Organization	Osaka University
Division name	Allergy and Rheumatic Diseases
Zip code
Address	2-2 Yamada-Oka, Suita, 565-0871 Japan
TEL	06-6879-3833
Homepage URL
Email	ryanjin@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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	大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 22 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	Terminated
Date of protocol fixation	2014 Year 03 Month 03 Day
Date of IRB	2014 Year 03 Month 03 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 21 Day
Last modified on	2019 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018004