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OctaPharma GAM10-08 (ProDERM Study)
||Prospective, Double-Blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients with Dermatomyositis
||Steven C, Vlad, MD, PhD
This study evaluates the beneficial effect of Octagam 10% given every 4 weeks compared to placebo in subjects with active dermatomyositis. Octagam 10% is an immune globlulin that is administered intravenously. Subjects will be randomly assigned to one of two groups: study drug group that will receive Octagam 10%, or a placebo group that will receive saline solution.
- Subjects with diagnosis of dermatomyositis
- Subjects under treatment with corticosteroids and/or maximum of 2 immune-suppressants and are on a stable therapy for at least 4 weeks
- Subjects who have previous failure of response or previous intolerance to corticosteroid and at least 1 additional immunosuprressive drug
- Subjects who have a body mass index (BMI) at least 40 kg/m²
- Subjects with a history of deep vein thrombosis within the last year
- Subjects starting or planning to start physical therapy-directed exercise
The duration of the entire study will be up to 43 weeks and consists of the following segments: up to 3 weeks for Screening, then 16 weeks of double-blind study phase (First Period), followed by 24 weeks of open-label study drug (Extension Period).
The study procedures include an ECG, urine pregnancy test for women, blood collection (total volume of blood collected is approximately 175 ml), physical examinations, and questionnaires.
The study drug/placebo is administered intravenously over 2 to 5 consecutive days .