Clinical Study on the Efficacy and Safety of Tofatib and Cyclophosphamide in the Treatment of Active IgG4 Related Diseases
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY
Compared with cyclophosphamide, the efficacy and safety of tofacitinib in the treatment of active IgG4-related diseases were evaluated.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• It meets the 2019 ACR/EULAR classification diagnostic criteria for IgG4 related diseases, and is an active IgG4-RD, defined as an IgG4-RD RI score ≥ 3 points when screening
Locations
Other Locations
China
Shanghai Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Gao Jie, doctor
gaojif@qq.com
13585561861
Time Frame
Start Date: 2022-11-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
Glucocorticosteroids combined with Cyclophosphamide Group
Glucocorticoid: 0.5-1.0 mg/kg/d prednisone (or other glucocorticoids of equivalent dose) for 1 month (visit V2-V3), then reduced by 5 mg every 2 weeks, and maintained at 5-10 mg/day to visit V8.~Cyclophosphamide: intravenous infusion, once a month, 0.5-1g/m2 each time, 6 times in total, until the end of visit V7.
Glucocorticoids combined with tofacitinib Group
Glucocorticoid: 0.5-1.0 mg/kg/d prednisone (or other glucocorticoids of equivalent dose) for 1 month (visit V2-V3), then reduced by 5 mg every 2 weeks, and maintained at 5-10 mg/day to visit V8.~Tofacitinib: oral, twice a day, 5mg each time, lasting for 6 months, until the end of visit V8.
Related Therapeutic Areas
Sponsors
Leads: Changhai Hospital