2024-516057-42-00RecruitingPhase 2
Intravenous immunoglobulin and prednisone vs. prednisone in newly diagnosed myositis: a double blind randomized clinical trial
Stichting Amsterdam UMC1 site in 1 country48 target enrollmentStarted: October 10, 2024Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Stichting Amsterdam UMC
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- treatment response at 12 weeks, measured by 'total improvement score'
Study Overview
Brief Summary
The main objective 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 with prednisone and placebo.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (≥ 18 years)
- •IIM diagnosis accordiging to diagnostic criteria: - dermatomyositis, - antisynthetase syndrome, - Immune mediated necrotizing myopathy, - overlap/non-specific myositis, including polymyositis.
- •Disease duration <12 months
- •Minimal disability defined as at least 10% loss on Manual Muscle Testing (MMT) and abnormal scores on two other Core Set Measures (CSMs) of the international Myositis Assessment and Clinical Studies (IMACS) group
- •Signed informed consent
Exclusion Criteria
- •Severe muscle weakness (i.e. bedridden, not able to walk, severe dysphagia requiring a nasogastric tube, or symptomatic respiratory muscle weakness (respiratory symptoms in combination with a forced vital capacity below 50% of predicted in upright position)) necessitating more intensive treatment than standard glucocorticoids.
- •A known malignancy, which is likely to interfere with outcome assessment.
- •Related to IVIg: o History of thrombotic episodes within 10 years prior to enrolment o Known allergic reactions or other severe reactions to any blood-derived product o Known IgA deficiency and IgA serum antibodies o Pregnancy or trying to conceive o Use of nephrotoxic medication
- •Conditions that are likely to interfere with: o Compliance (legally incompetent and/or incapacitated patients are excluded), or, o Evaluation of efficacy (e.g. due to severe pre-existing disability as a result of any disease other than myositis or due to a language barrier)
- •Immunosuppressive medication or immunomodulatory treatment within the last 3 months (e.g. azathioprine, methotrexate, mycophenolate mofetil, tacrolimus, cyclophosphamide, cyclosporine, IVIg, biologicals, Janus kinase inhibitors, plasmapheresis). Exceptions to abovementioned exclusion criteria: • Patients are eligible for inclusion if there is no clinical evident response (as carefully judged by the treating physician at a screening visit) to prior treatment with: • High dosed glucocorticoids, such as dexamethasone (e.g. 40 mg per day up to 4 days) or intravenous methylprednisolone (e.g. 1000 mg daily for three days), within 1 week prior to screening visit. • Daily dosed prednisone 1 mg/kg, or equivalent, used for up to 2 weeks prior to screening visit. • Treatment with biologicals or other immunosuppressive or immunomodulatory treatment when meeting all of the following criteria: o Stable dose for the last 6 months o The biological or other immunosuppressive or immunomodulatory treatment has been approved for a non-muscular condition (e.g. hematological condition, eczema) o The biological or other immunosuppressive or immunomodulatory treatment is not known to induce inflammatory myopathy
Outcomes
Primary Outcomes
treatment response at 12 weeks, measured by 'total improvement score'
treatment response at 12 weeks, measured by 'total improvement score'
Secondary Outcomes
- Biomarker (blood): interferon biomakers (CXCL-10, galectin-9 and Siglec-1)
- IgG blood levels
- 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
Investigators
J. Raaphorst
Scientific
Stichting Amsterdam UMC
Study Sites (1)
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