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Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

Primary Purpose

Autoimmune Diseases

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prednisone and Mycophenolate Mofetil
Mycophenolate Mofetil
Leflunomide
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Diseases focused on measuring Immunoglobulin G4-Related Disease, treatment strategies, relapse, leflunomide, mycophenolate mofetil

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria; 2. Newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment; 3. The addition of glucocorticoids was started at lower than 10 mg/d. Exclusion Criteria: 1. Patients who were diagnosed as other autoimmune diseases; 2. Patients who were diagnosed as malignant diseases; 3. Pregnant and lactating women; 4. Active infection: HIV, HCV, HBV, TB; 5. Severe irreversible damage of organ function; 6. Receipt of any biologic therapy or immunosuppressive agent other than GCs.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I

Group II

Arm Description

Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 4 months. Afterwards, patients are treated with low dose mycophenolate (0.5-1g/day) during remission maintenance period for 9 months.

Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 4 months. Afterwards, patients are treated with leflunomide (10-20 mg/day) during remission maintenance period for 9 months.

Outcomes

Primary Outcome Measures

The difference of relapse rate of IgG4-RD between two groups in 12 months.
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.

Secondary Outcome Measures

The difference of the time at baseline to first relapse between two groups.
Response rate to the treatment of the two groups.
Complete response rate; Partial response rate; No response
Side effects
Any side effects caused by treatments for IgG4-RD.

Full Information

First Posted
March 16, 2023
Last Updated
March 16, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05789017
Brief Title
Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement
Official Title
Efficacy of Mycophenolate Mofetil Versus Leflunomide as Maintenance Treatment for IgG4-RD Patients With Internal Organ Involvement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study has been designed as a 12-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in active IgG4-RD patients with internal organ involvement during maintenance remission period: low dose mycophenolate mofetil group and leflunomide group.
Detailed Description
60 active IgG4-RD patients with internal organ involvement are enrolled in this study and accept the combination treatment of glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 3 months. During remission maintenance period, pateints are randomly divided into two groups at a 1:1 ratio: patients in group I are treated with low dose mycophenolate mofetil (0.5-1g/day) and patients in group Ⅱ accept the treatment of leflunomide (10-20 mg/day). Patients in two groups will be followed up for another 6 months, and clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded during follow up. The primary endpoint is the difference of relapse rate between two groups at 12 months. The secondary endpoints are relapse time, response rate and side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Diseases
Keywords
Immunoglobulin G4-Related Disease, treatment strategies, relapse, leflunomide, mycophenolate mofetil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 4 months. Afterwards, patients are treated with low dose mycophenolate (0.5-1g/day) during remission maintenance period for 9 months.
Arm Title
Group II
Arm Type
Experimental
Arm Description
Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 4 months. Afterwards, patients are treated with leflunomide (10-20 mg/day) during remission maintenance period for 9 months.
Intervention Type
Drug
Intervention Name(s)
Prednisone and Mycophenolate Mofetil
Intervention Description
Patients are treated with glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 4 months.
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil
Intervention Description
Patients are treated with low dose mycophenolate (0.5-1g/day) during remission maintenance period for 9 months.
Intervention Type
Drug
Intervention Name(s)
Leflunomide
Intervention Description
Patients are treated with leflunomide (10-20 mg/day) during remission maintenance period for 9 months.
Primary Outcome Measure Information:
Title
The difference of relapse rate of IgG4-RD between two groups in 12 months.
Description
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.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
The difference of the time at baseline to first relapse between two groups.
Time Frame
12 months
Title
Response rate to the treatment of the two groups.
Description
Complete response rate; Partial response rate; No response
Time Frame
12 months
Title
Side effects
Description
Any side effects caused by treatments for IgG4-RD.
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria; 2. Newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment; 3. The addition of glucocorticoids was started at lower than 10 mg/d. Exclusion Criteria: 1. Patients who were diagnosed as other autoimmune diseases; 2. Patients who were diagnosed as malignant diseases; 3. Pregnant and lactating women; 4. Active infection: HIV, HCV, HBV, TB; 5. Severe irreversible damage of organ function; 6. Receipt of any biologic therapy or immunosuppressive agent other than GCs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunyun Fei, MD
Phone
01069159953
Email
feiyunyun@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Zhang, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunyun Fei, MD
Phone
01069159953
Email
feiyunyun@pumch.cn
First Name & Middle Initial & Last Name & Degree
Wen Zhang, MD

12. IPD Sharing Statement

Learn more about this trial

Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement

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