Learn about Research & Clinical Trials
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 70 Years|
- - meet the PM/DM diagnostic criteria according to Bohan-Peter.
- - consistent with ILD diagnosis.
- - predicted forced vital capacity (FVC) of at least 50% - patients who did not use immunosuppress agents (including but not limited to cyclophosphamide, cyclosporine, leflunomide, azathioprine, tacrolimus, etc.) at the time of screening, or who had stopped taking drugs for ≥3 months.
- - Anti MDA5 antibody positive DM and necrotizing myopathy.
- - patients if they had other connective tissue diseases, an underlying cancer, a concomitant active infection.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|First Affiliated Hospital Xi'an Jiaotong University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||First Affiliated Hospital Xi'an Jiaotong University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Idiopathic Inflammatory Myopathy, Interstitial Lung Disease|
Interstitial lung disease (ILD) is a common pulmonary manifestation of idiopathic inflammatory myopathy (IIM), with an incidence ranging from 23.1 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 disease（RP-ILD）or 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-ILD.This was a single-arm open-label pilot observational study. Patients were received prednisone (0.5mg-1.0mg/kg/d ) combined with MMF(1.5g-2.0g/d) for 12 months, 4 weeks later, reduced 5mg every two weeks to 10mg/d orally for 3 months, gradually reduced to 7.5mg/ day until 12 months.
Experimental: A single-arm open-label pilot observational study
Patients were received prednisone(0.5mg-1mg/kg/day) and a combination with MMF (1.5g-2.0g/d).
Drug: - Mycophenolate Mofetil
Prednisone 0.5-1.0 mg/kg/d, the dose was gradually reduced, and after 4 weeks, the dose was reduced by 5mg every two weeks, and then reduced to 10mg/d for 4-6 months after oral administration for 3 months, and then reduced to 7.5mg/d for maintenance therapy until 12 months; MMF1.5g-2.0g/d
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.