Idiopathic inflammatory myopathy
Conditions
Interventions
CTX group:Short interval cyclophosphamide pulse infusion and oral placebo
MTX group:Short interval normal saline pulse infusion and oral methotrexate
Sponsors
Qilu Hospital, Shandong University
Eligibility
Sex/Gender
All
Age
No minimum to 70 Years
Inclusion criteria
Inclusion criteria: 1. IIM patients who meet the 2004 ENMC diagnostic criteria, aged less than or equal to 70 years; 2. Before entering the group, electromyography, magnetic resonance imaging of both lower extremity muscles, 26 myositis antibody spectrum detection and muscle biopsy have been completed; 3. After a sufficient dose and a full course of hormone therapy (Prednisone acetate tablets 1mg/kg/d or 60mg/d for 6 weeks to 8 weeks), the mild improvement did not meet the IIM treatment evaluation criteria established by the American College of Rheumatology and the European Federation of Rheumatology in 2016; 4. Those who have good compliance, agree to participate in this clinical study, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have applied immunosuppressive agents, IVIG and various biological agents; 2. Sporadic inclusion body myositis; 3. Patients with malignant tumor; 4. Patients with rheumatic diseases (such as systemic lupus erythematosus, scleroderma, Sj?gren's syndrome or rheumatoid arthritis, etc., patients who have been previously diagnosed with these diseases but whose disease is no longer active will be eligible to participate in this trial); 5. Those with serious heart, liver, kidney and other serious concomitant diseases; 6. Chronic hepatitis B or C, chronic alcoholism; 7. Patients with pulmonary fibrosis and tuberculosis; 8. Severely infected patients; 9. Those with abnormal calcium metabolism that have not been corrected; 10. Uncontrolled diabetes mellitus or poorly controlled diabetes mellitus (fasting blood glucose >= 8.0 mmol/L after standard application of hypoglycemic drugs); 11. White blood cells < normal range, hemoglobin < 90g/L, platelets < 80*10^9g/L; 12. Those who affect gastrointestinal absorption (after gastrointestinal ulcer or gastrointestinal surgery); 13. Those who are breastfeeding, pregnant or trying to conceive; 14. Those who have a history of allergy to the test drug; 15. Those with a family history of neuromuscular disease; 16. Those who are deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of mild improvement after 12 months of enrollment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieved mild improvement, moderate improvement and significant improvement according to the American College of Rheumatology and European Federation of Rheumatology IIM treatment evaluation index after 3, 6, 9, and 12 months of treatment;Visual analog scoring;Time to mild improvement according to the American College of Rheumatology and European Federation of Rheumatology IIM Treatment Evaluation Index;Average prednisone dose after 12 months of enrollment;The incidence of adverse event and serious adverse event;Extramuscular symptom activity score; | — |
Countries
China
Contacts
Public ContactYan Chuanzhu
Qilu Hospital, Shandong University
Outcome results
None listed