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

Phase 1

• Conditions: idiopathic inflammatory myopathies; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-001710-37-NL
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-29
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

•Adult patients (18-80 years) with idiopathic inflammatory myopathy (IIM), according to diagnostic criteria:
- Dermatomyositis
- Non-specific/overlap myositis including antisynthetase syndrome; formerly known as polymyositis
- Immune mediated necrotizing myopathy
•Disease duration < 12 months
•Muscle biopsy including immunostaining (except in patients with characteristic skin features consistent with a diagnosis of dermatomyositis)
•Analysis of myositis specific antibodies
•Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

•Disease duration > 12 months
•Immunosuppressive medication within the last 12 months (azathioprine, methotrexate plasmapheresis, IVIg, biologicals). We will allow prednisone dosed as follows:
- Daily dose 20 mg or lower, used for two weeks or less
- Daily dose higher than 20 mg, used for 1 week or less
- No evident clinical response
•Related to IVIG:
- History of thrombotic episodes within 10 years prior to enrolment
- Known allergic reactions or other severe reactions to any blood-derived product
- Known IgA deficiency and IgA serum antibodies
- Pregnancy (wish)
•Conditions that are likely to interfere with:
- Compliance (legal incompetent and/or incapacitated patients are excluded), or,
- Evaluation of efficacy (e.g. due to severe pre-existing disability as a result of any other disease than myositis or due to language barrier)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified