Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05129410
Status:
UNKNOWN
Last Update Posted:
2021-11-22
First Post:
2021-11-10
Brief Title:
Clinical Study of MMF in Treatment of IIM-ILD and Its Effect on Peripheral Blood Treg Cells
Sponsor:
First Affiliated Hospital Xian Jiaotong University
Organization:
First Affiliated Hospital Xian Jiaotong University
Study Overview
Official Title:
Clinical Study of MMF in Treatment of IIM-ILD and Its Effect on Peripheral Blood Treg Cells
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Interstitial lung disease ILD is a common pulmonary manifestation of idiopathic inflammatory myopathy IIM The overall 5-year mortality is 50 The prognosis is poor and the treatment is challengingAt present according to the consensus of IIM-ILD experts glucocorticoids as first-line treatment are often used in high doses and have a variety of adverse reactions Previous studies have shown that cyclophosphamide CYC is effective for IIM-ILD and tends to be used in rapidly progressive interstitial lung diseaseRP-ILDor refractory ILD However CYC is an alkylating agent with many toxic and side effects It is prone to gonadal inhibition infection tumor hemorrhagic cystitis and other risks At present Mycophenolate mofetil MMF has been widly used in the treatment of IIM systemic lupus erythematosus SLE ANCA associated vasculitis AAV The observational research on MMF in the treatment of IIM-ILD shows that it can delay the progress of pulmonary fibrosis and can be used as the first-line treatment of IIM-ILD Moreover immune tolerance caused by defects in the number andor quality of regulatory T cells Treg is considered to be a key source of autoimmune diseases However it is unclear whether MMF can improve the immune status of IIM-ILD by increasing Treg cells The aim of this study was to evaluate the effect of MMF for IIM-ILD and its effcts on Treg through a prospective open single arm study and provide a theoretical basis for the individualized treatment of IIM-ILD which has important clinical significance
Detailed Description:
Interstitial lung disease ILD is a common pulmonary manifestation of idiopathic inflammatory myopathy IIM with an incidence ranging from 231 to 65 The treatment of IIM patients with ILD is challenging and the overall 5-year mortality is 50 The disease process of ILD from stable or slow to rapid Increased mortality and poor prognosis were observed which needs active treatment At present according to the consensus of IIM-ILD experts glucocorticoids as first-line treatment are often used in high doses but have a variety of adverse reactions Previous studies have shown that cyclophosphamide CYC is effective for IIM-ILD and tends to be used in rapidly progressive interstitial lung diseaseRP-ILDor refractory ILD However CYC is an alkylating agent with many toxic and side effects It is prone to gonadal inhibition infection tumor hemorrhagic cystitis and other risks Mycophenolate mofetil MMF has been widly used in the treatment of IIM systemic lupus erythematosus SLE ANCA associated vasculitis AAV The observational research on MMF in the treatment of IIM-ILD shows that it can delay the progress of pulmonary fibrosis and can be used as the first-line treatment of IIM-ILD Moreover immune tolerance caused by defects in the number and or quality of regulatory T cells Treg is considered to be a key source of autoimmune diseases In transplant patients studies have found that the combination of MMF and tacrolimus can increase the number of Treg cells in peripheral blood suggesting that MMF has a certain regulatory effect on Treg cells Therefore it is unclear whether MMF can improve the immune status of IIM-ILD by increasing Treg cells so as to improve the prognosis of the disease However it is unclear whether MMF can improve the immune status of IIM-ILD by increasing Treg cells The aim of this study was to evaluate the effect of MMF for IIM-ILD and its effcts on Treg through a prospective open single arm study and provide a theoretical basis for the individualized treatment of IIM-ILDThis was a single-arm open-label pilot observational study Patients were received prednisone 05mg-10mgkgd combined with MMF15g-20gd for 12 months 4 weeks later reduced 5mg every two weeks to 10mgd orally for 3 months gradually reduced to 75mg day until 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None