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

NCT02330445 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-10-16

No results posted yet for this study

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

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

PRTX-100

6 micrograms PRTX-100 per kilogram of body weight administered via infusion

Sponsors & Collaborators

  • Protalex, Inc.

    lead INDUSTRY

Principal Investigators

  • John B McClain, MD · Protalex, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-04-18
Completion
2016-11-30

Countries

  • United States

Study Locations

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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 NCT02330445 on ClinicalTrials.gov