Systemic lupus erythematosus, dermatomyositis/polymyositis, ANCA-associated vasculitis Systemic lupus erythematosus, dermatomyositis/polymyositis, ANCA-associated vasculitis
Conditions
Interventions
D000081364
Sponsors
Nakajima Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For patients with autoimmune disorders, the following criteria apply for inclusion: 1) Age at the time of consent is 18 years or older. 2) Patients who are newly diagnosed with autoimmune diseases (systemic lupus erythematosus, dermatomyositis/polymyositis, ANCA-associated vasculitis) and are scheduled to initiate corticosteroid therapy. 3) Patients receiving a daily dose of adrenal corticosteroids equivalent to or greater than 0.5 mg/kg/day of prednisolone. 4) Patients who have been adequately informed about their participation in this trial and have provided written consent prior to the commencement of the trial. For patients without autoimmune disorders, the following criteria apply for inclusion: 1) Age at the time of consent is between 18 and 70 years. 2) Patients without autoimmune disorders who have hip joint conditions. 3) Patients who have been adequately informed about their participation in this trial and have provided written consent prior to the commencement of the trial.
Exclusion criteria
Exclusion criteria: Individuals meeting any of the following conditions will not be eligible for inclusion in both the group of patients with autoimmune disorders and the group of patients without autoimmune disorders: 1) Patients with a history of continuous adrenal corticosteroid administration for more than 3 weeks (local administration such as inhaled steroids, topical steroids, steroid eye drops, joint injections, etc., are not considered). 2) Patients with a history of excessive alcohol consumption (approximately equivalent to an average of 100g or more of pure alcohol per day). 3)Patients with congenital coagulation abnormalities. 4)Patients who are pregnant, may be pregnant, within 28 days postpartum, or breastfeeding. 5) Patients undergoing dialysis or with chronic kidney disease (eGFR less than 30 mL/min/1.73 m^2). 6) Patients unable to undergo MRI examinations. 7) Other patients deemed unsuitable for participation in this trial by the principal investigator or collaborating physicians due to safety concerns.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No primary endpoint for exploratory study | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints 1) Evaluation of blood flow in the femoral head before, 4 weeks after, and 6 months after the start of corticosteroid treatment in patients with autoimmune diseases 2) Degree of change in blood flow in the femoral head before and 4 weeks after the start of corticosteroids and prediction of onset of osteonecrosis of the femoral head 6 months after the start of corticosteroids 3) Extraction of factors related to changes in femoral head blood flow and osteonecrosis of the femoral head 4) Incidence of femoral head necrosis by disease 5) Comparison of quantitative assessment of osteonecrosis of femoral head and femoral head blood flow between IVIM-MRI and contrast-enhanced MRI 6) Analysis of femoral head blood flow in patients with non-autoimmune diseases and comparison with patients with autoimmune diseases Safety endpoints 1) Incidence rate of adverse events 2) Incidence rate of equipment failure | — |
Contacts
Public ContactMasahiro Yasui
Chiba University Hospital
Outcome results
None listed