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Completed

NCT Number: NCT07827469

Tofacitinib in the Treatment of IgG4 Related Diseases

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Univercity, People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 ≤ 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.

Exclusion criteria

  • 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.

Treatment and study plan

Tofacitinib 5mg Oral Tablet

Drug

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

Prednisone 5Mg

Drug

all subjects were trteated immediately with prednisone after ranomized enrollment.

Primary outcomes

  1. IgG4-RD remission rate

    Time frame: 24 week

    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.

Secondary outcomes

  1. recurrence rate

    Time frame: 24 week

    compare the recurrence rates between two groups

  2. serum IgG4

    Time frame: 24 week

    compare the value of serum IgG4 between two groups

  3. rate of adverse events

    Time frame: 24 week

    Compare the incidence of treatment-related adverse events and treatment-related serious adverse events

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Randomized Open Label Clinical Study on the Efficacy of Tofacitinib in the Treatment of IgG4 Related Diseases

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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