NCT04124861

Withdraw Drug in Stable IgG4-Related Disease

Evaluation and Prediction of Relapse Risk After Glucocorticoid and Immunosuppressant Withdrawal in Patients With Stable IgG4 Related Disease: An Open-labeled Multi-centric Randomized Controlled Study From China

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Evaluation and prediction of relapse risk after glucocorticoid or immunosuppressant withdrawal in patients with stable IgG4 related disease: a prospective cohort study from china.

Detailed description

IgG4-related disease (IgG4-RD) is a chronic autoimmune disease with a relapsing-remitting course. For patients in remission, glucocorticoid (GC) and immunosuppressant are used to be maintained for a long time in fear of disease flare. Long-term GC and immunosuppressant could bring a lot of side-effects and economic burden. Whether and when patients with stable disease should withdraw GC or immunosuppressant? How about the relapse risk respectively? What are the risk factors for disease flare? All the above remain unclear. The aim of this study is to explore the relapse risk after GC or immunosuppressant withdrawal in IgG4-RD patients with stable disease and to establish a predictive model for risk stratification. Meanwhile the investigators aim to testify the effects of immunosuppressant in preventing IgG4-RD relapse. This study is a prospective cohort clinical trial.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	Drug free, IS monotherapy and GC combined with IS	Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).

Timeline

• Start date: 2020-06-23
• Primary completion: 2022-12-30
• Completion: 2023-06-30
• First posted: 2019-10-11
• Last updated: 2022-02-07

Locations

1 site across 1 country: China