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Add-on Intravenous Immunoglobulins in Early Myositis

NCT05832034 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Inflammatory Myopathy, Idiopathic
  • Dermatomyositis
  • Antisynthetase Syndrome
  • Immune-Mediated Necrotizing Myopathy
  • Polymyositis
  • Myositis

Interventions

DRUG

Immune Globulin Intravenous (Human)

IVIg is 2 g/kg over 2 to 5 days at baseline, followed by 2 g/kg IV in 2 to 5 days after 4 and 8 weeks. The rate of infusion is controlled by means of an infusion pump. The first dosage (30 grams IVIg) will be administered on the neurology ward.

DRUG

Placebo

Placebo infusions, containing sodium chloride 0.9%, at baseline and after 4 and 8 weeks.

Sponsors & Collaborators

  • Princess Beatrix Muscle Foundation

    collaborator OTHER

  • Prothya Biosolutions

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Raaphorst, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2025-09-25
Completion
2026-07-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832034 on ClinicalTrials.gov