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

NCT01749787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2014-12-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Protalex, Inc.

    lead INDUSTRY

Principal Investigators

  • William E Gannon, M.D. · Protalex, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01749787 on ClinicalTrials.gov