interventional
N/A
1 country
1
The main objective of this trial is to examine whether the addition of early administered IVIg to standard therapy with prednisone in patients with newly diagnosed myositis leads to an improved clinical response after 12 weeks, compared with prednisone and placebo.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2024
Actual (reported)treatment response at 12 weeks, measured by 'total improvement score'
Health related quality of life (HR-QoL) is measured by EQ-5D.
Physical functioning is measured by accelerometry.
Biomarker (imaging): assess the presence of muscle edema as a marker of disease activity by whole body muscle MRI
Biomarker (blood): interferon biomakers (CXCL-10, galectin-9 and Siglec-1)
IgG blood levels
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Amsterdam UMC Stichting
Amsterdam, 1081 HV, Netherlands
J. Raaphorst
First Submitted
September 26, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
Contact the study team to confirm eligibility.