Tokyo, Oct. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063242) titled 'Benefits and risks of adding immune-modifying medicines to steroid treatment for IgG4-related disease: a review of clinical trials' on Oct. 11.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Yokohama City University

Condition: Condition - IgG4-related disease (IgG4-RD) Classification by malignancy - Others Genomic information - NO

Objective: 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

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.

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072387

Disclaimer: Curated by HT Syndication.