FONTOLIZUMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

这个子项目是众多研究子项目之一

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to find out if Fontolizumab given intravenously is safe and well tolerated by patients with active RA. The study has two stages. Stage A: open label x 4 doses with those patients achieving 20% improvement continue on Stage B. Stage B: patients randomized to receive active drug or placebo x 5 doses. The dose level that is being tested throughout the study is 10.0 mg/kg of body weight, IV every 28 days. Efficacy of fontolizumab in subjects with active rheumatoid arthritis as determined by a 50% improvement of an American College of Rheumatology criteria (ACR50) response at Wk 14 (Stage A of study) will be evaluated. 1)To evaluate additional efficacy measures to include: Proportion of subjects achieving at least 20, 50, or 70% improvement according to the American College of Rheumatology criteria (ACR20, ACR50, ACR70) throughout the study. Percent change from baseline for individual components of the American College of Rheumatology criteria throughout the study. Change in C-reactive protein values throughout the study. Duration of response for subjects who receive four doses of fontolizumab (Stage A) compared with subjects who receive nine doses of fontolizumab (Stage A and B). Long-term evaluation of responders who receive four doses of fontolizumab versus subjects who receive nine doses of fontolizumab (Stage A and B). 2) To evaluate the safety of fontolizumab in subjects with active rheumatoid arthritis throughout the study. 3) To evaluate the pharmacokinetics (PK) of fontolizumab in subjects with active rheumatoid arthritis throughout the study. 4) To evaluate the immunogenicity of fontolizumab in subjects with active rheumatoid arthritis throughout the study.