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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: Completed Phase 1 study of Arthritis, Rheumatoid, sponsored by Protalex.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Number, severity, and attribution of relatedness of Adverse Events will be analyzed.

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
Protalex

4 total trials

What the finished NCT02330445 record still lists

NCT02330445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 641-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (98% lower).

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 a single indexed study location in 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.

Similar trials for Arthritis, Rheumatoid

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02330445's enrollment target sits among peer trials

13 28th of 27 the lowest of 27 other Arthritis, Rheumatoid trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Arthritis, Rheumatoid trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02330445, the US trial registry maintained by the National Library of Medicine. NCT02330445 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.