UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis
Title of the study (Brief title)	The assessment of tocilizumab for the treatment of systemic sclerosis
Region	Japan

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

Objectives
Narrative objectives1	To explore the effect of tocilizumab on patients with systemic sclerosis
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Sum of 17 areas skin score estimated by attandings
Key secondary outcomes	Sum of 17 areas z-score evaluated with Vesmeter, Range of joint mortions(ROM) and self-grading HAQ

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
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	Continue existing conventional therapies
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Nonpregnant adult agreeded to contraception if female 2) Patients with diffuse cutaneous systemic sclerosis fulfilled ACR criteria 3) Over 16 skin score with skin sclerosis on fingers, dorsal hands, forearms, and upper arms; change of total skin score is within 10% during the screening period (two months) 4) Patients who are able to give consent in writing after reading the explanatory text
Key exclusion criteria	1) A patient who fit the careful administration criteria in the package insert of tocilizumab, except for interstitial pneumonitis 2) A patient who has applied a drug trial within six months 3) A patient who are using cyclophosphamide or has received intravenous cyclophosphamide infusion 4) A patient who are receiving or has received biologics
Target sample size	24

Research contact person
Name of lead principal investigator	Yoshihito Shima
Organization	Osaka University Graduate School of Medicine
Division name	Respiratory Medicine, Allergy and Rheumatic Diseases
Address	2-2 Yamada-oka, Suita-city, Osaka565-0871, Japan
TEL	06-6879-3833
Email	ryanjin@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	Yoshihito Shima
Organization	Osaka University Graduate School of Medicine
Division name	Respiratory Medicine, Allergy and Rheumatic Diseases
Address	2-2 Yamada-oka, Suita-city, Osaka565-0871, Japan
TEL	06-6879-3833
Homepage URL
Email	ryanjin@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Program for the Promotion of Fundamental Studies in Health Sciences of the National Institute of Biomedical Innovation
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Rheumatology Keio University, Rheumatology Tokyo Women's Medical University, Dermatology Osaka University
Name of secondary funｄer(s)

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（大阪府）、慶應義塾大学病院（東京都）、東京女子医科大学膠原病リウマチ痛風センター（東京都）

Other administrative information
Date of disclosure of the study information	2011 Year 05 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 13 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2015 Year 01 Month 17 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 05 Month 15 Day
Date analysis concluded	2016 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	To explore the influence of the anti-interleukin-6 receptor antibody tocilizumab (TCZ) on patients with systemic sclerosis, we conducted a parallel group comparison study in three hospitals. At the end of 6 months, the average change in mRSS was larger in the TCZ group (6.3) than in the Conv group (3.4), but the difference was not statistically significant because of high variance in the TCZ group.
Other related information

Management information
Registered date	2011 Year 05 Month 03 Day
Last modified on	2017 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006582