6-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera Collection
Completed · Phase 1/Phase 2
Conditions studied: Arthritis, Rheumatoid
In brief
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
Key facts
- Study ID
- NCT02330445
- Run by
- Protalex, Inc.
- People needed
- 13
- Starts
- 2015-02-01
- Expected to finish
- 2016-11-30
- Last updated by the study team
- 2018-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Protalex Investigational Site — Coeur d'Alene, Idaho, United States
Full record on ClinicalTrials.gov
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