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Early IVIg plus prednisone versus prednisone alone in newly diagnosed myositis
NL-OMON49246Phase 3Recruiting
- Sponsor
- Amsterdam University Medical Center
- Start
- Sep 2021
- Modality
- Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in Autoimmune Myopathies, dermatomyositis (DM), Overlap Myositis (OM) and 2 more comparing IVIg + prednisone with Placebo + prednisone (2 arms). Primary endpoint: Total Improvement Score at week 12. Started Sep 2021; status: recruiting.
02
Drugs
immune globulinprednisone
03
Conditions
Autoimmune Myopathiesdermatomyositis (DM)Overlap Myositis (OM)antisynthetase syndrome (ASSD)immune-mediated necrotizing myopathy (IMNM)
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