Treatment Strategies in IgG4-RD Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period

July 26, 2023 updated by: Wen Zhang, Peking Union Medical College Hospital

A Study of Two Different Treatment Strategies in IgG4-related Disease Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period: a Randomized Double Blind Placebo Controlled Multicenter Study

This study has been designed as a 52-week, randomized double blind placebo controlled multicenter clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with re-elevation of serum IgG4 level during maintenance remission period: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

108 IgG4-RD patients with re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during maintenance remission period are to be enrolled in this study after screening period, and then double blind randomly in an 1:1 ratio into two groups: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD plus placebo) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD). The follow-up period will be 52 weeks. During the follow-up period, clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded. The primary endpoint is the difference of relapse rate between two groups at 52 weeks. Meanwhile, this study will also explore and study different biomarkers in IgG4-RD patients, to better understand the mechanisms, as well as prognostic factors of IgG4-RD.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Peking Union Medical College Hospital
        • Principal Investigator:
          • Wen Zhang, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria or the 2020 revised comprehensive diagnostic (RCD) criteria for IgG4-RD.
  • 2. Age between 18 and 70 years.
  • 3. Elevation of baseline serum IgG4 level (>1400mg/L).
  • 4. Major organ involvement, including but not limited to autoimmune pancreatitis, retroperitoneal fibrosis, sclerosing cholangitis, IgG4-related Castleman disease, and involvement of the lungs, kidney, nasal sinus, and central nervous system.
  • 5. Re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during maintenance remission period, with no evidence of relapse.
  • 6. Written informed consent signed.
  • 7. Agreed to take highly effective contraceptive procedures from signing of informed consent till 6 months after the end of last visit.

Exclusion Criteria:

  • 1. Patients with an IgG4-RD Responder Index ≥ 2 points of any organ system.
  • 2. IgG4-RD patients without major organ involvement.
  • 3. Patients with severe or active infections, including but not limited to HIV, HCV, HBV, TB.

  • 4. Patients with malignancies or a history of malignancies within 5 years, except:

    1. Patients with adenocarcinoma in situ (AIS) of the cervix who have received curative treatment for at least 12 months before screening.
    2. Patients with cutaneous basal or squamous cell carcinoma who have received curative treatment.
    3. Patients with prostate cancer, who have received radical prostatectomy or definitive radiotherapy for over 3 years, with no sign of relapse or ongoing treatment
  • 5. Patients with immunodeficiency diseases.
  • 6. Patients with severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neuropsychological, or constitutional comorbidities; or at risk of unacceptable complications, or having confounding factors in safety and explanation of results according to the evaluations from investigators.
  • 7. Patients with other rheumatic diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, sarcoidosis; or other mimickers of IgG4-RD, including but not limited to Rosai-Dorfman disease, Castleman disease.
  • 8. Participating in any other clinical trials with drug interventions.
  • 9. A history of alcohol or drug abuse, possibly harming patient's safety, compliance, or evaluation of study's safety or other necessary aspects according to the evaluations from investigators.
  • 10. Women during pregnancy, lactation, or planning of pregnancy within 6 months of the last visit of the study.

  • 11. Meeting any of the following blood test finding on screening:

    1. Hemoglobin level < 7.5g/dL.
    2. neutrophil count < 1.0×10^9/L.
    3. Platelet count < 100×10^9/L.
    4. Alanine aminotransferase (ALT) > 2 × upper limit number (ULN).
    5. Aspartate aminotransferase (AST) > 2 × ULN.
    6. Total Bilirubin (TBil) > 2 × ULN.
    7. Estimated glomerular filtration rate (eGFR) < 30ml/(min·1.73m^2), calculated using the Modification of Diet in Renal Disease (MDRD) study equation by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Basic Maintenance Treatment
Continue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
Drug: placebo
Continue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
Active Comparator: Enhancement Treatment
Use low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
Drug: mycophenolate mofetil
Use low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference of relapse rate of IgG4-RD between two groups in week 52.
Time Frame: 52 weeks
The primary endpoint is the difference of relapse rate between two groups at 52 weeks. The definition of relapse: elevation of IgG4-RD Responder Index ≥ 2 points; new organ involvement or recurrence, with or without elevation of serum IgG4 levels.
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The difference of relapse rate of IgG4-RD between two groups in the week 12.
Time Frame: 12 weeks
12 weeks
The difference of relapse rate of IgG4-RD between two groups in the week 24
Time Frame: 24 weeks
24 weeks
The difference of relapse rate of IgG4-RD between two groups in the week 36.
Time Frame: 36 weeks
36 weeks
The time and duration of relapse
Time Frame: 52 weeks
52 weeks
The changes of IgG4-RD Responder Index at week 52
Time Frame: 52 weeks
52 weeks
The changes of serum IgG level at week 52
Time Frame: 52 weeks
52 weeks
The changes of serum IgG4 level at week 52
Time Frame: 52 weeks
52 weeks
The changes of erythrocyte sedimentation rate at week 52
Time Frame: 52 weeks
52 weeks
The changes of serum C-reactive protein level at week 52
Time Frame: 52 weeks
52 weeks
Adverse effect events
Time Frame: 52 weeks
52 weeks
The changes of Physician Global Assessment score at week 52
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Friendship Hospital
Tongji Hospital

Investigators

  • Principal Investigator: Wen Zhang, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IgG4 re-elevation treatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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