Intravenous immunoglobulins as early treatment in newly diagnosed idiopathic inflammatory myopathies (IMMEDIATE): a pilot study.
- Conditions
- muscle inflammationmyositis10003816
- Registration Number
- NL-OMON46904
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
* Adult patients (age * 18 years);* Subacute-onset of disease (disease duration of * 9 months) of muscle symptoms;* Biopsy proven IIMs (see for diagnostic criteria Hoogendijk et al. 2004, note: ASS is considered a separate entity, but new criteria in which it has been included, has yet to be published).
o Dermatomyositis
o Non-specific myositis/antisynthetase syndrome
o Immune-mediated necrotizing myopathy;* Minimal disability of:
o MMT score reduction of 10% or lower and,
o 2 other of the core set measures score abnormalities defined as:
- Physician Global Activity 2 cm or more
- Patient Global Activity 2 cm or more
- Health Assessment Questionnaire 0.25 or more
- Muscle enzymes more than 1.5 times upper limit of normal
- Extra-Muscular Activity 2 cm or more
* IVIg treatment related:
o Subjects who have received clinical relevant immunosuppressive medication (e.g. plasmapheresis, biologicals, immune therapy etc.) within the last 6 months with the exception of prednisone dosed as follows:
* daily dose of 20mg or lower
* used for 2 weeks or less
* no evident clinical response;o history of thrombotic episodes within the 2 years prior to enrolment
o known allergic reactions or other severe reactions to any blood-derived product
o known IgA deficiency and anti-IgA serum antibodies
o pregnancy (wish).;* Conditions that are likely to interfere with:
o compliance (legal incompetent and/or incapacitated patients are excluded) or,
o evaluation of efficacy (e.g. due to severe pre-existing disability as result of any other disease than IIM or language barrier).;* Lack of informed consent (IC)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The number of patients with clinical significant improvement, defined as *40<br /><br>points improvement on a continuous, weighted score of 6 core set measures (a<br /><br>internationally validated and combined outcome measure of the International<br /><br>Myositis Assessment and Clinical Studies group) after 9 weeks of treatment.<br /><br>1. Physician Global Activity<br /><br>2. Patient Global Activity<br /><br>3. Manual Muscle Testing<br /><br>4. Health Assessment Questionnaire<br /><br>5. Muscle enzymes<br /><br>6. Extra-Muscular Activity </p><br>
- Secondary Outcome Measures
Name Time Method