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Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Primary Purpose

Autoimmune Diseases

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Diprospan plus iguratimod

Diprospan plus leflunomide

Prednisone plus leflunomide

About this trial

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

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 3

Arm Type

Experimental

Arm Label

Group I

Group II

Group Ⅲ

Arm Description

Patients are treated with Diprospan (1mL im) and then with iguratimod (25mg bid) for 12 months

Patients are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd) for 12 months.

Patients are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd) for 12 months.

Outcomes

Primary Outcome Measures

The difference of relapse rate of IgG4-RD among 3 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 among 3 groups

The difference of The difference of relapse time in 3 groups

The difference of the response rate of the treatment among the 3 groups.

Complete response rate; Partial response rate; No response

Side effects

Any side effects caused by treatments for IgG4-RD.

Full Information

NCT ID

NCT05789030

First Posted

March 16, 2023

Last Updated

March 16, 2023

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05789030

Brief Title

Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

Official Title

Treatment Strategies for IgG4-RD Patients With Superficial 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 30, 2024 (Anticipated)

Study Completion Date

December 30, 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

Studies a U.S. FDA-regulated Device Product

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 three treatment strategies in IgG4-RD patients with superficial organ involvement: Diprospan plus iguratimod, Diprospan plus leflunomide and prednisone plus leflunomide.

Detailed Description

90 IgG4-RD patients with superficial organ involvement are enrolled in this study and randomly divided into three groups at a 1:1:1 ratio: patients in group I are treated with Diprospan (1mL im) and then with iguratimod (25mg bid); patients in group Ⅱ are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd); and patients in group Ⅲ are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd). All patients will be followed up for 12 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, iguratimod, leflunomide, relapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Experimental

Arm Description

Patients are treated with Diprospan (1mL im) and then with iguratimod (25mg bid) for 12 months

Arm Title

Group II

Arm Type

Experimental

Arm Description

Patients are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd) for 12 months.

Arm Title

Group Ⅲ

Arm Type

Experimental

Arm Description

Patients are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd) for 12 months.

Intervention Type

Drug

Intervention Name(s)

Diprospan plus iguratimod

Intervention Description

Patients are treated with Diprospan (1mL im) and then with iguratimod (25mg bid) for 12 months.

Intervention Type

Drug

Intervention Name(s)

Diprospan plus leflunomide

Intervention Description

Patients are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd) for 12 months.

Intervention Type

Drug

Intervention Name(s)

Prednisone plus leflunomide

Intervention Description

Patients are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd) for 12 months.

Primary Outcome Measure Information:

Title

The difference of relapse rate of IgG4-RD among 3 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

12 months

Secondary Outcome Measure Information:

Title

The difference of the time at baseline to first relapse among 3 groups

Description

The difference of The difference of relapse time in 3 groups

Time Frame

12 months

Title

The difference of the response rate of the treatment among the 3 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

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yunyun Fei, MD

Phone

01069159953

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

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 Superficial Organ Involvement

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