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NCT02330445 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Arthritis, Rheumatoid, sponsored by Protalex.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target
1
Study location

NCT02330445 is a Phase 1 study of Arthritis, Rheumatoid that has completed, run by Protalex. The registered enrollment target is 13 participants, below the 641-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02330445, a Phase 1 study of Arthritis, Rheumatoid, has completed, sponsored by Protalex.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DRUG PRTX-100

Study Locations (1)

Idaho

  • Protalex Investigational Site - Coeur d'Alene

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2015-02
Est. Completion 2016-11-30
Phase Phase 1

Sponsor

Protalex

4 total trials

What the Registry Record Tells You About NCT02330445

The ClinicalTrials.gov registry entry for NCT02330445 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 641-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (98% lower). The listed sponsor is Protalex, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 1 intervention - of which PRTX-100 is the first listed.

NCT02330445 reports 1 study location spanning 1 distinct geographic area - top geographies include Idaho.

Frequently Asked Questions

What is clinical trial NCT02330445 about?

NCT02330445 is a clinical study titled "6-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera Collection". 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 tr...

What is the current status of trial NCT02330445?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2015-02. Estimated completion is 2016-11-30.

What conditions does trial NCT02330445 study?

This clinical trial studies the following conditions: Arthritis, Rheumatoid.

What interventions are being tested in trial NCT02330445?

The interventions under investigation include: PRTX-100 (DRUG).

Who is sponsoring clinical trial NCT02330445?

This trial is sponsored by Protalex, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02330445 being conducted?

This trial has 1 study location across Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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