Status:
COMPLETED
Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM
Lead Sponsor:
Institute of Rheumatology, Prague
Collaborating Sponsors:
Karolinska Institutet
Conditions:
Polymyositis
Dermatomyositis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Therapeutical trial in patients with idiopathic polymyositis (PM) and dermatomyositis (DM) is proposed. The study will investigate the safety and efficacy of combined methotrexate (MTX) + glucocortico...
Detailed Description
Clinical trial: A prospective, randomized, assessor- blind, multicenter study of safety and efficacy of combined treatment of methotrexate and glucocorticoids versus glucocorticoids alone in patients...
Eligibility Criteria
Inclusion
- Age between 18 - 80 years.
- Patients with definite or probable polymyositis or dermatomyositis diagnosed according to diagnostic criteria (9, 10) (Appendix 1)
- Physician's own judgment of the disease activity that requires high dose immunosuppressive treatment (based on clinical assessment of weakness, elevation of muscle enzymes and, if available, on magnetic resonance imaging findings).
- Previously untreated patients with the exception of glucocorticoid treatment up to 8 weeks
- Signed informed consent.
Exclusion
- Treatment with any immunosuppressive drug prior the study start.
- Treatment with glucocorticoids (\> 20 mg of Prednisone or equivalent) more than 8 weeks prior to study start.
- Drug induced myositis.
- Polymyositis and dermatomyositis in association with other connective tissue disease.
- Inclusion body myositis.
- Patients with immunodeficiency syndrome.
- Pregnancy and lactation.
- Fertile women not using adequate contraception during the study, women planning to have children during the study course or 12 months after the end of the study.
- Malignancy.
- Juvenile dermatomyositis.
- Uncontrolled, clinically significant hematological, cardiovascular, pulmonary, endocrine, metabolic, gastrointestinal, hepatic or renal disease, which according to physician's consideration would interfere with high dose glucocorticoid and immunosuppressive treatment or would prevent to follow the treatment protocol.
- Severe infection.
- History of drug or alcohol abuse within the previous 6 months.
- Patients known to be HIV positive.
- Known hypersensitivity to methotrexate.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00651040
Start Date
May 1 2008
End Date
November 1 2014
Last Update
May 12 2016
Active Locations (1)
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1
Revmatologicky ustav
Prague, Czechia, 12850