UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005550 |
|---|---|
| Receipt number | R000006582 |
| Scientific Title | Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis |
| Date of disclosure of the study information | 2011/05/23 |
| Last modified on | 2017/04/18 18:13:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis
Acronym
The assessment of tocilizumab for the treatment of systemic sclerosis
Scientific Title
Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshihito Shima |
Organization
Osaka University Graduate School of Medicine
Division name
Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
Address
2-2 Yamada-oka, Suita-city, Osaka565-0871, Japan
TEL
06-6879-3833
ryanjin@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihito Shima |
Organization
Osaka University Graduate School of Medicine
Division name
Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
Address
2-2 Yamada-oka, Suita-city, Osaka565-0871, Japan
TEL
06-6879-3833
Homepage URL
ryanjin@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
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.
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
| 2011 | Year | 04 | Month | 13 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006582
