Tofatib Treatment for IgG4-related Disease

Recruiting

• Conditions: IgG4-related Disease
• Interventions: Drug: tofacitinib

• Registration Number: NCT05625581
• Lead Sponsor: Changhai Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-10
• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-15
• Last Update Submitted: 2022-11-15
• Study First Posted: 2022-11-23
• Last Update Posted: 2022-11-23
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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;

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glucocorticosteroids combined with Cyclophosphamide Group	tofacitinib	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	tofacitinib	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 Measures

Name	Time	Method
Disease remission rate at 1 month, 3 months and 6 months of treatment (%)	1 month, 3 months and 6 months of treatment	Definition of disease remission: including ① complete remission (CR) (main efficacy index), partial remission (PR), continuous complete remission (CCR) and no change (NC).

Secondary Outcome Measures

Name	Time	Method
Response rate at 1 month, 3 months and 6 months after treatment (%)	1 month, 3 months and 6 months after treatment	Defined as IgG4-RD RI score decrease ≥ 1 point
Changes in physician's overall assessment (PGA) from baseline at 1 month, 3 months and 6 months of treatment	1 month, 3 months and 6 months of treatment	First, the doctor evaluated the overall situation of IgG4 - RD subjects and marked them at the corresponding position of the straight line in the form of a vertical vertical line "l". The straight line is a 100mm scale, where the 0 end of the straight line represents very good, and the 100mm end represents very poor.
Disease recurrence rate at 3 and 6 months after treatment (%)	3 and 6 months after treatment	There are two types of disease recurrence, clinical recurrence and serological recurrence. Clinical recurrence was defined as recurrence of clinical symptoms or deterioration of imaging findings, with or without elevated serum IgG4 levels; Serological relapse was defined as an increase in serum IgG4 level and an increase in IgG4-RD RI score of ≥ 1 point after treatment, without recurrence of clinical symptoms or deterioration of imaging manifestations. The isolated increase of serum IgG4 concentration only constitutes serological recurrence. The date of recurrence is the date of onset of symptoms, or the date of new or deteriorated physical examination, laboratory examination or radiological examination results.

Trial Locations

Locations (1)

Shanghai Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China