Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Considering the known effects of IVIg in idiopathic inflammatory myopathies (IIM), both as add-on therapy in refractory patients, as well as monotherapy in newly diagnosed IIM, we conducted a phase-2 double-blind placebo-controlled randomized trial to investigate the effect of add-on IVIg in patients with newly diagnosed IIM, who are treated with monotherapy prednisone. Objective: The primary aim 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 to prednisone and placebo. Clinical response will be measured as the difference of the mean TIS after 12 weeks between intervention and control groups. The secondary aims are to examine whether the intervention leads to a shorter time to improvement, and sustained positive effects on health-related quality of life, physical activity and fatigue, and a sustained reduction of muscle MRI abnormalities, as assessed up to 52 weeks. Following a screening visit at the outpatient clinic, patients will be admitted to the neurology ward of the Amsterdam University Medical Center (AUMC) for the first infusion of study treatment. The remaining study medication will be administered at home, according to routine clinical practice for IVIg treatment in neuromuscular disorders in the Netherlands. A second and third study treatment will be administered at home after 4 and 8 weeks. At baseline and after 4, 8, 12, 26 and 52 weeks outcome assessments will be performed at the outpatient clinic. The outpatient study clinic visits at baseline and after 4, 12, 26 and 52 weeks will be combined with regular outpatient clinic visits. The additional burden related to outcome assessments will consist of MRI muscle imaging after 12 weeks, blood sampling after 2, 4, 6, and 10 weeks and filling in questionnaires at baseline and after 4, 8, 12, 26 and 52 weeks. In addition, participants are asked to wear a watch three times in a period of 12 weeks and after 26 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05832034
Study type Interventional
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Raaphorst, MD, PhD
Phone +3120 7327672
Email j.raaphorst@amsterdamumc.nl
Status Recruiting
Phase Phase 2
Start date September 13, 2021
Completion date September 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05833711 - Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy Phase 2
Not yet recruiting NCT06284954 - A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis Phase 2
Completed NCT01906372 - Acthar in Treatment of Refractory Dermatomyositis and Polymyositis Phase 2
Completed NCT01813617 - Outcome in Patients With Recent Onset Polymyositis and Dermatomyositis N/A
Completed NCT01165008 - Anakinra in Myositis Phase 2/Phase 3
Completed NCT00004357 - Absorption of Corticosteroids in Children With Juvenile Dermatomyositis Phase 2
Recruiting NCT05979441 - A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy Phase 3
Not yet recruiting NCT05027152 - Muscle Function and Effects of Repetitive Task Training in Patients With Inflammatory Myopaties N/A
Active, not recruiting NCT04723303 - Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM) Early Phase 1
Completed NCT03267277 - Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis Phase 2/Phase 3
Recruiting NCT05437263 - A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis Phase 3
Active, not recruiting NCT04044690 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) Phase 3
Recruiting NCT05523167 - A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy. Phase 2/Phase 3
Not yet recruiting NCT06004817 - Evaluation of Severity in Juvenile and Adult-onset Dermatomyositis
Recruiting NCT03324152 - Effects of High-intensity Interval Training (HIIT) in Recent Onset Polymyositis and Dermatomyositis N/A
Completed NCT02043548 - Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis Phase 2
Completed NCT03414086 - Predictor of Clinical Response to Acthar in Myositis
Completed NCT04628936 - Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM. Phase 2
Recruiting NCT03293615 - Exercise Capacity of Patients With Dermatomyosis N/A
Recruiting NCT06462768 - Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis