Tofatib Treatment for IgG4-related Disease

Status Recruiting

Clinical Trial Summary

Compared with cyclophosphamide, the efficacy and safety of tofacitinib in the treatment of active IgG4-related diseases were evaluated.

Clinical Trial Description

This study is a prospective, single center, non randomized, controlled, open label clinical observation study to evaluate the efficacy and safety of tropitib versus cyclophosphamide in inducing remission in IgG4-RD patients. 2) Investigators observe the diagnosis and treatment of IgG4-RD patients, and only provide patients with clinically appropriate diagnosis and treatment proposals. It does not interfere with the choice of treatment plan for patients with the study drug of tropib or cyclophosphamide. If the patient chooses the hormone combined with tofatib or the hormone combined with cyclophosphamide as the main treatment drug, and at the same time meets the inclusion and exclusion criteria of this study, the patient can be included in this clinical observation study and become a subject. The experimental group was treated with glucocorticoid combined with tofatib, and the control group was treated with glucocorticoid combined with cyclophosphamide. It is planned that 20 people in each group will be treated for 6 months. After the study, the number of subjects in each group shall be at least 20 according to the actual situation. In the final statistical analysis, ensure that the sample size of the two groups participating in the statistical analysis is controlled at about 1:1. 3) The primary end point of this study was to compare the remission rate of the two groups after treatment; The secondary end point was to compare the response rate, recurrence rate and adverse event rate of the two groups after treatment. ;

Study Design

Related Conditions & MeSH terms

IgG4-related Disease

Clinical Trial Details

NCT number	NCT05625581
Study type	Observational
Source	Changhai Hospital
Contact	Gao Jie, doctor
Phone	13585561861
Email	gaojif@qq.com
Status	Recruiting
Phase
Start date	November 10, 2022
Completion date	December 31, 2025

View Details

See also
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