Clinical trial NCT05625581: Tofatib Treatment for IgG4-related Disease
Official title: Clinical Study on the Efficacy and Safety of Tofatib and Cyclophosphamide in the Treatment of Active IgG4 Related Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IgG4-related Disease
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IgG4-RD

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Disease remission rate at 1 month, 3 months and 6 months of treatment (%)
timeFrame: 1 month, 3 months and 6 months of treatment
Secondary outcomes:
measure: Response rate at 1 month, 3 months and 6 months after treatment (%)
timeFrame: 1 month, 3 months and 6 months after treatment
measure: Disease recurrence rate at 3 and 6 months after treatment (%)
timeFrame: 3 and 6 months after treatment
measure: Changes in physician's overall assessment (PGA) from baseline at 1 month, 3 months and 6 months of treatment
timeFrame: 1 month, 3 months and 6 months of treatment
Other outcomes:
measure: Changes in the number of organs involved and IgG4-RD RI scores from the baseline after 6 months of treatment
timeFrame: 6 months of treatment
measure: Changes of IgG4 level and related immunological indicators from baseline after 6 months of treatment
timeFrame: 6 months of treatment
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Gao Jie, doctor
role: STUDY_CHAIR
References: