An ongoing clinical trial is evaluating RoActemra/Actemra (tocilizumab) in patients with systemic sclerosis (SSc). Sponsored by Hoffmann-La Roche, this clinical trial is in phase 3, with primary outcomes of a change in modified Rodnan skin score (mRSS) and incidence of adverse events.
Currently Actemra, otherwise known by the chemical name tocilizumab, is a medication prescribed to some individuals with moderate to severe rheumatoid arthritis. As an engineered biologic disease modifier, tocilizumab can modify the immune system by blocking the cytokine interleukin 6 (IL-6), which is associated with autoimmune diseases such as SSc. It is available in intravenous or subcutaneous formulations.
In the present study, patients enrolled in the study will receive either subcutaneous tocilizumab or placebo for 48 weeks. Beyond these 48 weeks, all patients will receive tocilizumab for another 48 weeks, giving a total time of treatment of 96 weeks.
Multiple centers are involved in the study, and recruitment locations include a few centers in the United States, France, Canada, United Kingdom, and Germany. For all patients, inclusion criteria include active SSc as defined by the American College of Rheumatology, an age greater than 18 years, and uninvolved skin at sites for injection.
In addition to the primary criteria, patients will be assessed for a change in physical function through the Scleroderma Health Assessment Questionnaire-Disability Index, a change in joint tenderness, immunogenicity, pharmacokinetics, and pharmacodynamics as assessed by serum IL-6 and IL-6 receptor levels. With the conclusion of the this trial, Hoffmann-La Roche may be able to open its drug RoActemra/Actemra to patients with SSc, depending on the outcomes of disease modification and safety profiles.