UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007702 |
|---|---|
| Receipt number | R000009084 |
| Scientific Title | Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis |
| Date of disclosure of the study information | 2012/04/24 |
| Last modified on | 2023/10/18 12:14:57 |
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Basic information
Public title
Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis
Acronym
Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis
Scientific Title
Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis
Scientific Title:Acronym
Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis
Region
| Japan |
Condition
Condition
Interstitial lung disease secondary to systemic sclerosis
Classification by specialty
| Pneumology | Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement in lung function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lung function test
Key secondary outcomes
Assessment of interstitial lung disease progression on CT
Serum levels of KL-6 and SP-D
Assessment of Safety
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
Rituximab(+)
30weeks
375mg/m2
once a week
4 times
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)interstitial lung disease secondary to systemic sclerosis
2)resistance to standard treatment (oral prednisolone + cyclophosphamide pulse)
3)untreatable with cyclophosphamide pulse because of advers effects
4)no desired effect of cyclophosphamide pulse on interstitial lung disease from the results of SP-D, KL-6 and clinical course
5)no malignancy
6)from 20 years old to 80 years old
7)obtaining informed consent
Key exclusion criteria
1)during treatment with equal drug
2)previous history of anaphylactic reactions to this drug
3)significant infection
4)significant liver damage
5)significant renal damage
6)less than or equal to 60% of %VC or 40% of %DLco
7)previous history of significant infection
8)pregnancy
9)breast-feeding
10)participating in other clinical trial within three months before the beginning of this trial
11)judged inappropriate for this study by the physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Yoshizaki |
Organization
The University of Tokyo
Division name
Department of Dermatology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8661
yoshizakiay-der@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Yoshizaki |
Organization
The University of Tokyo
Division name
Department of Dermatology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8661
Homepage URL
yoshizakiay-der@h.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Dermatology, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research center, The University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
Tel
03-5800-8743
crctky-office@umin.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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 24 | 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
| 2012 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 09 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009084
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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