UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059198 |
|---|---|
| Receipt number | R000067705 |
| Scientific Title | Retrospective Observational Study on Treatment Efficacy Following Switching from Neutralizing Antibodies to Receptor Antibodies in EGPA |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/09/26 09:55:40 |
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Basic information
Public title
A Retrospective Observational Study on Treatment Outcomes Following Switching to Anti-IL-5 Therapy in EGPA
Acronym
Observational Study on Treatment Outcomes Following Treatment Modifications in EGPA
Scientific Title
Retrospective Observational Study on Treatment Efficacy Following Switching from Neutralizing Antibodies to Receptor Antibodies in EGPA
Scientific Title:Acronym
Observational Study on Switching Antibody Therapies in EGPA
Region
| Japan |
Condition
Condition
eosinophilic granulomatosis with polyangiitis: EGPA
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the impact on treatment efficacy following changes in antibody therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Asthma Symptom Score (ACT), Lung Function, Peripheral Eosinophil Count
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing anti-IL-5 antibody therapy for EGPA.
Patients who provided consent.
Key exclusion criteria
Patients who did not provide consent.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | ATSUMI |
Organization
Saitama Medical University Hospital
Division name
General Internal Medicine
Zip code
350-0495
Address
38 Morohon'go, Moroyama-machi, Iruma-gun, Saitama Prefecture
TEL
0492761667
atsumi-takao@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takehito |
| Middle name | |
| Last name | KOBAYASHI |
Organization
Saitama Medical University Hospital / Saitama Prefectural Cardiovascular and Respiratory Center
Division name
General Internal Medicine, Respiratory Medicine, Emergency Medicine / General Internal Medicine
Zip code
350-0495 / 360-0197
Address
38 Morohon'go, Moroyama-machi, Iruma-gun, Saitama / 1696 Itai, Kumagaya City, Saitama Prefe
TEL
048-536-9900
Homepage URL
kobayashi.takehito@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Takehito KOBAYASHI
Funding Source
Organization
none
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
Saitama Medical University Hospital Clinical Research Center Hospital IRB Office
Address
38 Morohon'go, Moroyama-machi, Iruma-gun, Saitama Prefecture
Tel
049-276-1354
hirb@saitama-med.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
| 2025 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing to report
This examination is an observational study
Management information
Registered date
| 2025 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067705
