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

Phase 3

Recruiting

Conditions: muscle inflammation
myositis
10003816

Registration Number: NL-OMON49246

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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
• Signed informed consent

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Total Improvement Score (TIS) of the myositis response criteria after week<br /><br>12 compared to baseline t=0, before treatment.<br /><br>Total Improvement Score is based on 6 validated core set measures which each<br /><br>determine disease activity as defined by the International Myositis Assessment<br /><br>and Clinical Studies (IMACS) group. </p><br>

Secondary Outcome Measures