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Add-on Intravenous Immunoglobulins in Early Myositis

Study acronym: TIMEISMUSCLE
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Phase 2 to Phase 2/3 Primary completion date changed from estimate of Feb 2024 to Sep 25, 2025 · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 48 to confirmed 44 · 5 morev2 Show 8 more changesShow less
    • Primary completion date changed from estimate of Feb 2024 to Sep 25, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 48 to confirmed 44
    • Completion date: Sep 2024 to Jul 2026
    • Eligibility criteria shortened, about 15 words
    • Secondary endpoints: 19 to 21
    • Site details revised
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov