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Intravenous immunoglobulin and prednisone vs. prednisone in newly diagnosed myositis: a double blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516057-42-00
Enrollment
48
Registered
2024-10-10
Start date
2024-10-10
Completion date
Unknown
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic inflammatory myopathy

Brief summary

treatment response at 12 weeks, measured by 'total improvement score'

Detailed description

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

Interventions

DRUGNatriumchloride 0
DRUG9 % m/v
DRUGoplossing voor infusie
DRUGNanogam 100 mg/ml oplossing voor infusie

Sponsors

Stichting Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
treatment response at 12 weeks, measured by 'total improvement score'—

Secondary

MeasureTime frame
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—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026