Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-13003178
• Date of registration: 2013-01-03
• Prospective Registration: Yes
• Primary sponsor: Department of rheumatology, China-Japan Friendship hospital
• Public title: Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study
• Scientific title: Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study
• Date of first enrolment: 2013-05-01
• Target sample size: group1-predinsone group(control group):94;group1-predinsone+MTX group:94;group1-predinsone+LEF group:94;group2-predinsone group(control group):94;group2-predinsone+CTX group:94;group2-predinsone+MTX group:94;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=6381
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Xin Lu
• Affiliation: Department of rheumatology, China-Japan Friendship hospital

• Name: Guochun Wang

Key inclusion & exclusion 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: 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.

Age minimum: 18
Age maximum: 70
Gender: Both

Health Condition(s) or Problem(s) studied

Polymyositis/Dermatomyositis

Intervention(s)

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, maintenance therapy to 72 weeks; 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,maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;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.;

Primary Outcome(s)

Disease activity core set measures recommended by international myositis outcome assessment collaboration;

Secondary Outcome(s)

ESR;CRP;KL-6;SP-D;MCP-1;anti-Jo-1 antibody;

Source(s) of Monetary Support

Self-financing