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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2015-02 |
| Est. Completion | 2016-11-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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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Related
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