- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05789017
Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement
March 16, 2023 updated by: Wen Zhang, Peking Union Medical College Hospital
Efficacy of Mycophenolate Mofetil Versus Leflunomide as Maintenance Treatment for IgG4-RD Patients With Internal Organ Involvement
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
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
- Name: Yunyun Fei, MD
- Phone Number: 01069159953
- Email: feiyunyun@pumch.cn
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Yunyun Fei, MD
- Phone Number: 01069159953
- Email: feiyunyun@pumch.cn
-
Principal Investigator:
- Wen Zhang, MD
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I
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.
Patients are treated with low dose mycophenolate (0.5-1g/day) during remission maintenance period for 9 months.
|
Experimental: Group II
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.
|
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.
Patients are treated with leflunomide (10-20 mg/day) during remission maintenance period for 9 months.
|
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 12 months.
Time Frame: 15 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.
|
15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference of the time at baseline to first relapse between two groups.
Time Frame: 12 months
|
12 months
|
|
Response rate to the treatment of the two groups.
Time Frame: 12 months
|
Complete response rate; Partial response rate; No response
|
12 months
|
Side effects
Time Frame: 15 months
|
Any side effects caused by treatments for IgG4-RD.
|
15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wen Zhang, MD, Peking Union Medical College Hospital
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 (Actual)
July 1, 2022
Primary Completion (Anticipated)
December 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
March 16, 2023
First Submitted That Met QC Criteria
March 16, 2023
First Posted (Actual)
March 29, 2023
Study Record Updates
Last Update Posted (Actual)
March 29, 2023
Last Update Submitted That Met QC Criteria
March 16, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Prednisone
- Leflunomide
- Mycophenolic Acid
Other Study ID Numbers
- Management for IgG4-RD
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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