Tofatib Treatment for IgG4-related Disease

Naval Military Medical University

Status: Enrolling

Conditions: IgG4-related Disease

Treatments: Drug: tofacitinib

Study type: Observational

Funder types: Other

Identifiers

NCT05625581

CHEC2022-175

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 1. IgG4 related diseases endangering organ function or life;

  2. Only Mikulicz disease, no other internal organs involved;

  3. People with history of thrombotic disease or high risk of thrombosis;

  4. Have a history of malignant tumor;

  5. Active infection;

  6. Pregnant or lactating women;

Trial design

40 participants in 2 patient groups

Glucocorticosteroids combined with Cyclophosphamide Group

Description:

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.

Treatment:

Drug: tofacitinib

Glucocorticoids combined with tofacitinib Group

Description:

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.

Treatment:

Drug: tofacitinib