NCT01749787

Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis

A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Protalex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	PRTX-100 at 1.5 mcg/kg
DRUG	PRTX-100 at 3.0 mcg/kg
DRUG	PRTX-100 at 6.0 mcg/kg
DRUG	PRTX-100 at 12.0 mcg/kg
DRUG	PRTX-100 at 240 mcg
DRUG	Placebo	Placebo administered via infusion once per week for 5 weeks
DRUG	PRTX-100 at 420 mcg

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-12-17
• Last updated: 2014-12-23

Locations

8 sites across 1 country: United States