6-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera Collection

Summary

Part A Primary Objective To determine the safety of six months of PRTX-100 administration. Part B Primary Objective To obtain antisera from normal volunteers that have developed anti-PRTX-100 antibodies. Secondary Objective(s) To assess rheumatoid arthritis activity during the period of PRTX-100 treatment To evaluate the development of anti-PRTX-100 antibodies To explore feasibility of joint evaluations with ultrasound To explore feasibility of biomarkers as disease markers

Timeline

Start

2015-02

Primary completion

2016-04-18

Completion

2016-11-30

Drugs

Indications