Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
This study was stopped prematurely due to overall slow recruitment and no evidence for efficacy in a parallel study in dermatomyositis with an assumed similar pathophysiology. With very small sample sizes per group the overall results for this study including primary and all other efficacy and PD data are inconclusive
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
"definite" or "probable" for polymyositis at least three months before Baseline
active disease as defined by elevated CK levels, or other enzymes, or MRI/biopsy if enzymes are normal, and persisting muscle weakness
stable dose of corticosteroid for at least 2 weeks prior to Baseline and should not have received a medium or high dose in the last 8 weeks prior to study entry.
patients treated with methotrexate must have been on a stable dose for at least 6 weeks prior to Baseline.
You may not be if
Patients with overlap polymyositis, late-stage polymyositis, or other types of myositis.
Preexisting severe cardiac or pulmonary involvement, malignancy of any organ system or significant eye diseases.
Uncontrolled diabetes mellitus or diabetes complicated with organ involvement.
