NCT02703194

Leflunomide for Maintenance of Remission in IgG4 Related Disease

A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study has been designed as a 12-month, open-label, randomized, controlled study comparing the use of prednisone mono-therapy and prednisone and leflunomide combination therapy in treating patients with IgG4-related disease.

Detailed description

The aim of this clinical trial is to determine the safety and efficacy of Leflunomide in treating patients with IgG4-related disease by comparing the outcomes of prednisone and leflunomide combination therapy with prednisone mono-therapy. The follow-up period will be 12 months. During the follow-up period, results of laboratory tests and image examinations, IgG4-RD RI and other parameters which can reflect treatment response as well as adverse effect events will be recorded.

Conditions

• Immunoglobulin G4 Related Sclerosing Disease

Interventions

Type	Name	Description
DRUG	Prednisone	Prednisone:A starting dose of 0. 5-0. 8mg/(kg\*d) will be given. Following four-week period, the dose will be tapered gradually to 5mg/d until the end of 12 months of follow-up period.
DRUG	Leflunomide	Leflunomide:A starting dose of 20 mg/day will be given. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor adverse effects occur(e.g., liver enzyme elevations).

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-03-09
• Last updated: 2019-03-06

Locations

1 site across 1 country: China