UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063242 |
|---|---|
| Receipt number | R000072387 |
| Scientific Title | Efficacy and Safety of Immunomodulatory Therapies Added to Glucocorticoid-Based Treatment for IgG4-Related Disease: A Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2026/10/11 |
| Last modified on | 2026/10/11 10:58:44 |
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Basic information
Public title
Benefits and risks of adding immune-modifying medicines to steroid treatment for IgG4-related disease: a review of clinical trials
Acronym
IgG4-RD add-on therapy review
Scientific Title
Efficacy and Safety of Immunomodulatory Therapies Added to Glucocorticoid-Based Treatment for IgG4-Related Disease: A Systematic Review and Meta-Analysis
Scientific Title:Acronym
IgG4-RD immunomodulatory add-on therapy meta-analysis
Region
| Japan |
Condition
Condition
IgG4-related disease (IgG4-RD)
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To synthesize randomized trials comparing immunomodulatory therapies added to glucocorticoid-based treatment with corresponding glucocorticoid-based treatment alone or placebo with the same taper in IgG4-related disease. Efficacy, safety and glucocorticoid-sparing effects will be assessed, considering differences in therapies, glucocorticoid regimens and outcome definitions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients experiencing trial-defined IgG4-related disease relapse or flare, primarily at approximately 12 months (52 weeks) after treatment initiation. Differences in relapse/flare definitions and background glucocorticoid regimens will be considered in the analysis.
Key secondary outcomes
Trial-defined remission or complete remission, primarily at approximately 12 months (52 weeks); proportion of patients with at least one adverse event; proportion with serious adverse events; time to first relapse/flare; annualized flare rate; and cumulative rescue glucocorticoid dose through week 52. Safety outcomes will use each trial's follow-up period. Remission definitions and total versus rescue glucocorticoid doses will be distinguished, and only comparable data will be pooled.
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Randomized controlled trials in patients with IgG4-related disease comparing added immunomodulatory therapy plus glucocorticoid-based treatment with corresponding glucocorticoid-based treatment alone or placebo with the same taper, reporting evaluable relapse/flare, remission or safety data. No additional age or sex restriction will be imposed.
Key exclusion criteria
Nonrandomized studies, observational studies, case reports, reviews, duplicate data and trials not matching the specified comparison will be excluded. Trials comparing glucocorticoid maintenance with withdrawal without evaluating added immunomodulatory therapy will be excluded. Multiple reports of the same trial will be linked to avoid double counting.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Shimada |
Organization
Yokohama City University
Division name
Department of Molecular Biodefense Research, Graduate School of Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
81-45-787-2794
mshimada@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Shimada |
Organization
Yokohama City University
Division name
Department of Molecular Biodefense Research, Graduate School of Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
81-45-787-2794
Homepage URL
mshimada@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Masaru Shimada
Funding Source
Organization
None (no specific funding)
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
Not applicable for meta-analysis
Address
Not applicable for meta-analysis
Tel
-
N/A
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
| 2026 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 01 | Month | 11 | Day |
Other
Other related information
Systematic review and meta-analysis of randomized trials of add-on immunomodulatory therapy with glucocorticoid-based treatment for IgG4-RD. Searches cover records through 30 September 2026. Literature searching is ongoing; quantitative synthesis is incomplete. Comparable outcomes will be pooled using random-effects models, considering therapy class and outcome definitions. No new participants or individual patient data are collected; published aggregate data are used and ethics review is not applicable.
Management information
Registered date
| 2026 | Year | 10 | Month | 11 | Day |
Last modified on
| 2026 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072387
