Clinical Trial

Add-on Intravenous Immunoglobulins in Early Myositis

Study acronym: TIMEISMUSCLE
Active, Not Recruiting Phase 2/3
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Summary
In patients with myositis early immunomodulation by intensive treatment ("hit-early/hit-hard" principle) may induce faster reduction of disease activity and prevent chronic disability. Intravenous immunoglobulin (IVIg) in addition to standard treatment with glucocorticoids may be beneficial for this purpose: add-on IVIg improved symptoms in steroid-resistant myositis, and first-line monotherapy IVIg led to a fast and clinically relevant response in a pilot study in nearly 50% of patients with myositis.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-04-14.
Status change: Recruiting → Active, Not Recruiting 2026-02-26
Trial Details
NCT Number NCT05832034
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: Princess Beatrix Muscle Foundation, Prothya Biosolutions
Conditions Inflammatory Myopathy, Idiopathic, Dermatomyositis, Antisynthetase Syndrome, Immune-Mediated Necrotizing Myopathy, Polymyositis, Myositis
Enrollment 44 participants
Start Date 2021-09-13
Primary Completion 2025-09-25 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-27