A prospective study on myofiber contractility in myositis
- Conditions
- idiopathic inflammatory myopathyMyositis1002830210029317
- Registration Number
- NL-OMON56586
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 54
- Adult patients (18-80 years) with IIM, according to the diagnostic criteria
and the presence of the following antibodies.
o IMNM with anti-SRP antibodies
o IMNM with anti-HMGCR antibodies
o IMNM without MSA (seronegative)
o (Dermato)myositis with or without MSA
- 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.
- Newly diagnosed (aim 1+2), established diagnosis (aim 3).
- Without immunosuppressive medication (exceptions are allowed; duration of
treatment and dosage in case of pre-treatment in combination with the
medication-free time interval is at the discretion of treating physician).
- Signed informed consent.
- Administration of IVIg in the 12 months before screening.
- Conditions that are likely to interfere with
o Compliance (legal incompetent and/or incapacitated patients are excluded)
o Evaluation of efficacy (e.g., due to severe pre-existing disability because
of any other disease than myositis or due to language barrier)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Changes in contractile function (specific force) between 1st and 2nd biopsy<br /><br>after 10 to 15 weeks of treatment with standard of care immunosuppressive<br /><br>medication. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Imaging of the muscles:<br /><br>MRI: quantitative assessment of edema, fat infilatration and contractile<br /><br>cross-sectional area, muscle fiber integrity and muscle fiber membrane<br /><br>stability.<br /><br>Ultrasound: qualitative and quantitative analysis; including muscle fiber<br /><br>elasticity and muscle fiber direction.<br /><br><br /><br>Muscle biopsy:<br /><br>Changes in histological markers between the first and second biopsy.<br /><br>- Complement activation in muscle tissue.<br /><br>- the degree of inflammatory infiltrates.<br /><br>- the presence of regeneration, degeneration and necrosis.<br /><br><br /><br>Clinical:<br /><br>Change of muscle strength over time - assessment according to Kendall and<br /><br>isometric knee extension assessment.<br /><br>Clinical improvement and response to treatment by using the Total Improvement<br /><br>Score.<br /><br>Mean daily prednisone dosage</p><br>