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

ClinicalTrials.gov ID: NCT01749787

Public ClinicalTrials.gov record NCT01749787. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01749787
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Protalex, Inc.; Industry
Enrollment: 61 participants

Conditions and interventions

Conditions

Arthritis, Rheumatoid

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 31, 2012
Primary completion: Jul 31, 2014
Completion: Jul 31, 2014
Last update posted: Dec 22, 2014

2012 – 2014

United States locations

U.S. sites: 8
U.S. states: 8
U.S. cities: 8

Facility	City	State	ZIP	Site status
Protalex Investigative Site	Los Angeles	California	90036	—
Protalex Investigational Site	Sarasota	Florida	34239	—
Protalex Investigational Site	Coeur d'Alene	Idaho	83814	—
Protalex Investigational Site	Anderson	Indiana	46011	—
Protalex Investigational Site	Albuquerque	New Mexico	87102	—
Protalex Investigational Site	Salisbury	North Carolina	28144	—
Protalex Investigational Site	Duncansville	Pennsylvania	16635	—
Protalex Investigational Site	Allen	Texas	75013	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01749787, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 22, 2014 · Synced Sep 11, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01749787 live on ClinicalTrials.gov.

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