Polymyositis/Dermatomyositis
Conditions
Interventions
group1-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg / d, then reduce 2.5mg every two weeks to 5mg/d,
seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.
group1-predinsone+MTX group:MTX 10-20mgQw×24w
MTX 7.5-10mgQw×48w, the usage of prednisone is the same as in the control group.
group1-predinsone+LEF group:LEF 20mg/d×24w
LEF 10mg/d×48w, the usage of prednisone is the same as in the control group.
group2-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg/d, then reduce 2.5mg every two weeks to 5mg/d,ma
group2-predinsone+CTX group:CTX iv 0.8-1.0g/4w×24w
CTX iv 0.8-1.0g/12w×48w, the usage of prednisone is the same as in the control group.
group2-predinsone+MTX group:MMF 1.5-2.0g /d×24w
MMF 0.75-1g/d×48w, the usage of prednisone is the same as in the control group.
Sponsors
Department of rheumatology, China-Japan Friendship hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients must meet the diagnostic criteria of IIM and/or ADM, the group with ILD must satisfy the diagnostic criteria of IIM and/or ADM and ILD at the same time. Patients are included in the study if all of the following criteria are met: 1. aged between 18 and 70 years; 2. The patient agrees to take effective contraceptive measures (women of childbearing age) during the study period; 3. The patient is voluntary to sign an informed consent form; 4. The patient with initial diagnosis of IIM and initial treatment; Or the patient with previous diagnosis of IIM and disease recurrence after treatment, but the dosage of oral prednisone was no more than 0.5mg/kg/d for at least four weeks at the screening time; 5. The patient has no use of immunosuppressants (including but not limited to methotrexate, leflunomide, cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, hydroxychloroquine, sand lee thalidomide, Tripterygium and biological agents, etc.) or discontinuation of drugs above for no less than 4 weeks.
Exclusion criteria
Exclusion criteria: Patients are excluded from participating in this study if one or more of the following criteria are met: 1. PM/DM patient combined with other connective tissue diseases; 2. PM/DM patient combined with tumor; 3. The patient with serious heart, liver, kidney, other vital organs disease or blood, endocrine system lesions, the evaluation criteria are as follows: (1) liver function >= 2 times the upper limit of normal range(except for ALT, AST increase due to PM/DM); (2) creatinine >=1.5 times the upper limit of normal range; (3) white blood cell count <3*10^9/L (or below the lower limit of normal range according to different laboratory); (4) hemoglobin <80g/L; (5) platelet count <60*10^9/L; 4. The patient received biologic therapies in less than 3 months; 5. The patient received intravenous glucocorticoid therapy in less than 4 weeks; 6. The patient is within the process of acute or chronic infection, or has a past history of active tuberculosis; 7. HbsAg(+) or anti-HCV(+); 8. The patient is allergy to multiple drugs; 9. The patient has psychiisatric disorders or other reasons that can not cooperate with treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease activity core set measures recommended by international myositis outcome assessment collaboration; | — |
Secondary
| Measure | Time frame |
|---|---|
| ESR;CRP;KL-6;SP-D;MCP-1;anti-Jo-1 antibody; | — |
Countries
China
Contacts
Public ContactGuochun Wang
Outcome results
None listed