UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049326 |
|---|---|
| Receipt number | R000056174 |
| Scientific Title | Analysis of Adaptive Immunomodulation Before and After Anifrolumab Treatment |
| Date of disclosure of the study information | 2023/01/11 |
| Last modified on | 2024/04/28 17:38:41 |
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Basic information
Public title
Analysis of Adaptive Immunomodulation Before and After Anifrolumab Treatment
Acronym
BCRANIFRO
Scientific Title
Analysis of Adaptive Immunomodulation Before and After Anifrolumab Treatment
Scientific Title:Acronym
BCRANIFRO
Region
| Japan |
Condition
Condition
Systemic lupus erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the effect of anifrolumab on B cell receptor repertoire
Basic objectives2
Others
Basic objectives -Others
B cell receptor repertoire will be assessed before and after anifrolumab treatment using single cell RNAseq.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
B cell receptor repertoire before and 6 months after anifrolumab treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
SLE patients who are going to start anifrolumab treatment at the discretion of the treating physician
Key exclusion criteria
1. Patients with other connective tissue diseases or systemic autoimmune diseases (complication with antiphospholipid antibody syndrome controlled by appropriate anticoagulant therapy and connective tissue diseases that do not affect the judgment on the efficacy of anifrolumab are not excluded).
2.Complication with serious life-threatening lung disease.
3.Complication with serious active lupus nephritis or central lupus, for which steroid pulse therapy or cyclophosphamide is indicated.
etc.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Keishi |
| Middle name | |
| Last name | Fujio |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Allergy and Rheumatology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
FUJIOK-INT@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Tsuchida |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Allergy and Rheumatology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
yumitsuchida@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Astrazeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, the effect of anifrolumab on the BCR repertoire will be assessed using single cell RNA-sequencing.
Management information
Registered date
| 2022 | Year | 10 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056174
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
