Tofacitinib in the Treatment of IgG4 Related Diseases

NCT07827469 | Completed

• 1 other identifier: TIRED
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single centre, open label, randomized controlled study to compare the efficacy and safety between steroids plus tofacitinib and steroids alone in active IgG4-related diseases patients. It is expected to enroll a total of 58 IgG4 RD patients. The sample size of two groups is 1:1. The primary end points of this study is to compare the IgG4-RD response rate between two groups at 24 weeks.

Conditions

Immunoglobulin G4-Related Disease; Janus Kinase Inhibitors

Keywords

IgG4-related Disease, Tofacitinib,efficacy, safety

Outcome Measures

Primary Outcomes (1)

• IgG4-RD remission rate

  Evaluate treatment response by assessing changes in the IgG4 RD RI score and categorize it into three types: complete response (CR), partial response (PR), and no effect (NE, including no improvement or deterioration). IgG4 RD RI score\<3 and a decrease of ≥ 2 is considered CR; A decrease of ≥ 2 in IgG4 RD RI score but a maintenance of ≥ 3 is considered PR. If the patient's IgG4 RD RI score is initially 3 points, a decrease of 1 point after treatment is considered PR. Patients with no significant changes in tumor size and/or clinical presentation and a decrease in IgG4 RD RI score\<2 are considered NE.

  24 week

Secondary Outcomes (3)

• recurrence rate

  24 week

• serum IgG4

  24 week

• rate of adverse events

  24 week

Study Arms (2)

steroids plus tofacitinib

EXPERIMENTAL

Prednisone (or equivalent drug) 0.6mg/kg/d orally. When the calculated values of two groups of prednisone are not multiples of 5, the dose of prednisone less than 5mg is rounded off. The initial dose should not exceed 60mg/day. If it exceeds 60mg/day, the medication should be administered at a rate of 60mg/day. Reduce the dosage by 5 mg every 2 weeks until reaching the maintenance dose of 5 mg/d. Tofacitinib: 5mg,bid

Drug: Tofacitinib 5mg Oral Tablet; Drug: Prednisone 5mg

steroids alone

PLACEBO COMPARATOR

Prednisone (or equivalent drug) 0.6mg/kg/d orally. When the calculated values of two groups of prednisone are not multiples of 5, the dose of prednisone less than 5mg is rounded off. The initial dose should not exceed 60mg/day. If it exceeds 60mg/day, the medication should be administered at a rate of 60mg/day. Reduce the dosage by 5 mg every 2 weeks until reaching the maintenance dose of 5 mg/d.

Drug: Prednisone 5mg

Interventions

Tofacitinib 5mg Oral Tablet DRUG

all subjects were trteated immediately after ranomized enrollment. Patients in experimental arm is treated with tofacitinib plus prednisone.

steroids plus tofacitinib

Prednisone 5mg DRUG

all subjects were trteated immediately with prednisone after ranomized enrollment.

steroids alone; steroids plus tofacitinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ Age ≤ 70 years old;
• Complies with the 2019 ACR/EULAR IgG4 RD classification criteria
• Patients with initial or recurrent active IgG4 RD (IgG4 RD RI ≥ 3 points).
• Voluntary signing of informed consent: Patients must be given a written consent form when participating in the trial, and it is hoped that patients can comply with the requirements of the study follow-up plan and other protocols;
• Female participants of childbearing age agreed to use effective contraceptive measures during the study period.

You may not qualify if:

• Participants in other trials or those who have participated in clinical trials of other drugs within 2 months;
• Individuals who have received live vaccine immunization within 2 weeks prior to enrollment, or who require live vaccine immunization during the trial period;
• Merge other autoimmune diseases
• Active infected individuals need to be excluded. Latent tuberculosis requires prevention with isoniazid 0.3g/d one month in advance; People with hepatitis B HBsAg+and HBV-DNA negative need to take anti hepatitis B virus drugs one month in advance.
• Pregnant and lactating women, or women of childbearing age who have fertility requirements during the study period and within 6 months after the last dose of medication;
• Patients with a history of thromboembolism, or severe diseases such as coronary heart disease and other important organs such as the heart, brain, liver, lung, kidney, and hematopoietic system, malignant tumors, and psychiatric disorders;
• Other researchers believe that it is not suitable for enrollment.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking Univercity, People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

tofacitinib; Tablets; Prednisone

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 18, 2026
• Study Start: April 1, 2023
• Primary Completion: June 3, 2026
• Study Completion: June 3, 2026
• Last Updated: September 18, 2026

Record last verified: 2024-01

Locations

CN (1)