Tofatib Treatment for IgG4-related Disease

Sponsor
Changhai Hospital
Study ID
NCT05625581
Status
Unknown

Conditions

  • IgG4-related Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • tofacitinib — DRUG
    All subjects were treated immediately after non randomized enrollment. The treatment scheme of the experimental group: glucocorticoid+tropitib; the treatment scheme of the control group: glucocorticoid+cyclophosphamide.

Study Details

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

Key Dates

Start date
Nov 10, 2022
Status verified
Nov 2022
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Disease remission rate at 1 month, 3 months and 6 months of treatment (%) [ Time Frame: 1 month, 3 months and 6 months of treatment ]

Central Contacts

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