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Withdraw Drug in Stable IgG4-Related Disease

Primary Purpose

Autoimmune Diseases

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Drug free, IS monotherapy and GC combined with IS

About this trial

This is an interventional treatment trial for Autoimmune Diseases focused on measuring Immunoglobulin G4-Related Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients must meet the following diagnostic criteria of IgG4RD (2011): 1)Swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2)Elevated serum IgG4 (>1.35 g/L); 3)Histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD. exclusion of other diseases.
Disease stabilized more than one year (Responder Index < 2 points)
Dose of Glucocorticoid(GC): prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months
Immunosuppressant: one of the following drugs, the same dose maintain at least 3 months (Mycophenolate mate <= 1g/d or Leflunomide <=20mg/d or Methotrexate <=12.5mg/w or Azathioprine <=100mg/d).

Exclusion Criteria:

Patient was diagnosed other connective tissue diseases
Patient with tumor
Women during pregnancy or planning pregnancy
Patient with active infections, including HIV, HCV, HBV, TB, etc.
Patient with severe irreversible organ damage
Active IgG4-RD, responder index >= 2 points
Stable condition less than one year.
Patient with two or more immunosuppressive agents.
Biological agents (such as CD20 monoclonal antibody and TNF-a inhibitor) have been used for half a year before admission.
Patient with IgG4-RD recurrence during hormone reduction in the past.

Sites / Locations

Beijing Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Drug free

IS monotherapy

GC combined with IS

Arm Description

Arm A: Drug free Glucocorticoid（GC）is tapered and stopped in 8 weeks(GCs at a dose of ≤ 2.5 mg of prednisone or equivalent for treatment of adrenal insufficiency) . Immunosuppressant is also tapered and discontinues in 8 weeks.

Arm B: Immunosuppressant only Glucocorticoid（GC）is tapered and stopped in 8 weeks. The same type and dosage of immunosuppressive agent before admission, including Mycophenolate mate(<= 1g/d) or Leflunomide (<=20mg/d) or Methotrexate (<=15mg/w) or Azathioprine (<=100mg/d)

Arm C: GC+Immunosuppressant Both Glucocorticoid(GC) (no more than 7.5mg/d) and immunosuppressant are kept as maintaining dose.

Outcomes

Primary Outcome Measures

The difference of recurrent rate of IgG4-RD among three groups.

Clinical recurrence definition: any item of IgG4-RD Responder Index >=2，new organ involvement; with or without elevated serum IgG4 levels. Serum recurrence definition: Serum IgG4 level was higher than baseline level, IgG4-RD Responder Index was higher than or equal to 1 point, without clinical symptom or imaging deterioration.

Secondary Outcome Measures

The changes of IgG4-RD Responder Index

According to IgG4-RD responder Index Validation Study (Version: 13, December, 2015)

The changes of serum IgG4 levels

Level of serum IgG4(mg/dL)

The changes of serum IgG level

Level of serum IgG(g/L)

The changes of serum hsCRP level

Level of serum high-sensitivity C-reactive protein level(mg/L)

The changes of ESR

Serum erythrocyte sedimentation rate(mm/h)

The percentages of adverse events

Adverse effect of drugs

Full Information

NCT ID

NCT04124861

First Posted

February 13, 2019

Last Updated

January 21, 2022

Sponsor

Peking Union Medical College Hospital

Collaborators

Chinese PLA General Hospital, Peking University People's Hospital, The People's Hospital of Hebei Province, Shengjing Hospital, Tongji Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04124861

Brief Title

Withdraw Drug in Stable IgG4-Related Disease

Official Title

Evaluation and Prediction of Relapse Risk After Glucocorticoid and Immunosuppressant Withdrawal in Patients With Stable IgG4 Related Disease: An Open-labeled Multi-centric Randomized Controlled Study From China

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 23, 2020 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

Chinese PLA General Hospital, Peking University People's Hospital, The People's Hospital of Hebei Province, Shengjing Hospital, Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Evaluation and prediction of relapse risk after glucocorticoid or immunosuppressant withdrawal in patients with stable IgG4 related disease: a prospective cohort study from china.

Detailed Description

IgG4-related disease (IgG4-RD) is a chronic autoimmune disease with a relapsing-remitting course. For patients in remission, glucocorticoid (GC) and immunosuppressant are used to be maintained for a long time in fear of disease flare. Long-term GC and immunosuppressant could bring a lot of side-effects and economic burden. Whether and when patients with stable disease should withdraw GC or immunosuppressant? How about the relapse risk respectively? What are the risk factors for disease flare? All the above remain unclear. The aim of this study is to explore the relapse risk after GC or immunosuppressant withdrawal in IgG4-RD patients with stable disease and to establish a predictive model for risk stratification. Meanwhile the investigators aim to testify the effects of immunosuppressant in preventing IgG4-RD relapse. This study is a prospective cohort clinical trial.

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drug free

Arm Type

Experimental

Arm Description

Arm Title

IS monotherapy

Arm Type

Experimental

Arm Description

Arm Title

GC combined with IS

Arm Type

Experimental

Arm Description

Arm C: GC+Immunosuppressant Both Glucocorticoid(GC) (no more than 7.5mg/d) and immunosuppressant are kept as maintaining dose.

Intervention Type

Drug

Intervention Name(s)

Drug free, IS monotherapy and GC combined with IS

Intervention Description

Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).

Primary Outcome Measure Information:

Title

The difference of recurrent rate of IgG4-RD among three groups.

Description

Time Frame

One and half year

Secondary Outcome Measure Information:

Title

The changes of IgG4-RD Responder Index

Description

According to IgG4-RD responder Index Validation Study (Version: 13, December, 2015)

Time Frame

One and half year

Title

The changes of serum IgG4 levels

Description

Level of serum IgG4(mg/dL)

Time Frame

One and half year

Title

The changes of serum IgG level

Description

Level of serum IgG(g/L)

Time Frame

One and half year

Title

The changes of serum hsCRP level

Description

Level of serum high-sensitivity C-reactive protein level(mg/L)

Time Frame

One and half year

Title

The changes of ESR

Description

Serum erythrocyte sedimentation rate(mm/h)

Time Frame

One and half year

Title

The percentages of adverse events

Description

Adverse effect of drugs

Time Frame

One and half year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients must meet the following diagnostic criteria of IgG4RD (2011): 1)Swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2)Elevated serum IgG4 (>1.35 g/L); 3)Histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD. exclusion of other diseases. Disease stabilized more than one year (Responder Index < 2 points) Dose of Glucocorticoid(GC): prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months Immunosuppressant: one of the following drugs, the same dose maintain at least 3 months (Mycophenolate mate <= 1g/d or Leflunomide <=20mg/d or Methotrexate <=12.5mg/w or Azathioprine <=100mg/d). Exclusion Criteria: Patient was diagnosed other connective tissue diseases Patient with tumor Women during pregnancy or planning pregnancy Patient with active infections, including HIV, HCV, HBV, TB, etc. Patient with severe irreversible organ damage Active IgG4-RD, responder index >= 2 points Stable condition less than one year. Patient with two or more immunosuppressive agents. Biological agents (such as CD20 monoclonal antibody and TNF-a inhibitor) have been used for half a year before admission. Patient with IgG4-RD recurrence during hormone reduction in the past.

Central Contact Person:

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

linyi peng, MD.

Phone

+8615810395901

drpenglinyi@163.com

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

First Name & Middle Initial & Last Name & Degree

Yunyun Fei, MD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Friendship Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100050

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanying Liu, MD

Phone

13581746850

liuyanying20030801@msn.com

12. IPD Sharing Statement

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