Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the safety and tolerability of PRTX-100 when
various doses are given 5 times at weekly intervals to patients with active rheumatoid
arthritis that are taking methotrexate or leflunomide. The drug is administered in a
physician's office via an intravenous infusion. PRTX-100 may be effective in rheumatoid
arthritis by suppressing the immune responses.
PRTX-100 is a highly-purified bacterial protein called Staphylococcal Protein A. In this
study, cohorts of patients with active RA will receive sequentially higher doses of PRTX-100.
There will be an inactive placebo cohort for comparison. Patients who do not attain low RA
disease activity, by a commonly used measure, will leave the study at 3 months after their
first dose of study drug.