Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone

MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.

Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone
Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms

1Prednison

MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.

2Prednison MTX

Total

Sex: Female, Male

Region of Enrollment

The primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment.

Prednison1

Prednison Methotrexate 2

The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.

Assessment of Disease Activity and Damage,Muscle Strength and Endurance, Enzyme Levels, Glucocorticoid Side-effects, Dose, HAQ,SF-36, Treatment Failures

Overall Study

Rheumatology Institute Prague

1 Prednison

2 Prednison Methotrexate

Polymyositis

Dermatomyositis

Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms

Prednisone

Methotrexate

Revmatologicky ustav

Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM

A Prospective, Randomised, Assessor-blind, Multicenter Study of Efficacy and Safety of Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With Polymyositis and Dermatomyositis.

Institute of Rheumatology, Prague

Karolinska Institutet

Patients with known or suspected Idiopathic Inflammatory myopathies (IIM)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Study and Treatment of Inflammatory Muscle Diseases

Studies on the Natural History and Pathogenesis of Polymyositis, Dermatomyositis, and Related Diseases

To determine its utility in differentiating different muscle diseases, in identifying early extra muscular involvement of muscle diseases, in characterizing the pattern of muscle involvement for the diseases studied, and whether it can serve as a diagnostic tool to better identify muscle inflammation and atrophy.

polymyositis/ödəm

Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM

Study and Treatment of Inflammatory Muscle Diseases

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