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Intravenous immunoglobulin and prednisone vs. prednisone in newly diagnosed myositis: a double blind randomized clinical trial

Phase 2
Not yet recruiting
Conditions
Idiopathic inflammatory myopathy
Registration Number
2024-516057-42-00
Lead Sponsor
Stichting Amsterdam UMC
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised, recruitment pending
Sex
Not specified
Target Recruitment
48
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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
treatment response at 12 weeks, measured by 'total improvement score'

treatment response at 12 weeks, measured by 'total improvement score'

Secondary Outcome Measures
NameTimeMethod
Health related quality of life (HR-QoL) is measured by EQ-5D.

Health related quality of life (HR-QoL) is measured by EQ-5D.

Physical functioning is measured by accelerometry.

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

Biomarker (imaging): assess the presence of muscle edema as a marker of disease activity by whole body muscle MRI

Biomarker (blood): interferon biomakers (CXCL-10, galectin-9 and Siglec-1)

Biomarker (blood): interferon biomakers (CXCL-10, galectin-9 and Siglec-1)

IgG blood levels

IgG blood levels

Trial Locations

Locations (1)

Amsterdam UMC Stichting

🇳🇱

Amsterdam, Netherlands

Amsterdam UMC Stichting
🇳🇱Amsterdam, Netherlands
Joost Raaphorst
Site contact
0205663443
j.raaphorst@amsterdamumc.nl

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