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NCT01749787 · ClinicalTrials.gov registry record · Phase 1
Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis
A Phase 1 study, sponsored by Protalex.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01749787 is a Phase 1 study that has completed, run by Protalex. The registered enrollment target is 61 participants.
The verdict
NCT01749787, a Phase 1 study, has completed, sponsored by Protalex.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and tolerability of PRTX-100 when various doses are given 5 times at weekly intervals to patients with active rheumatoid arthritis that are taking methotrexate or leflunomide. The drug is administered in a physician's office via an intravenous infusion. PRTX-100 may be effective in rheumatoid arthritis by suppressing the immune responses. PRTX-100 is a highly-purified bacterial protein called Staphylococcal Protein A. In this study, cohorts of patients with active RA will receive sequentially higher doses of PRTX-100. There will be an inactive placebo cohort for comparison. Patients who do not attain low RA disease activity, by a commonly used measure, will leave the study at 3 months after their first dose of study drug.
Interventions
- DRUG PRTX-100 at 1.5 mcg/kg
- DRUG PRTX-100 at 3.0 mcg/kg
- DRUG PRTX-100 at 6.0 mcg/kg
- DRUG PRTX-100 at 12.0 mcg/kg
- DRUG PRTX-100 at 240 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01749787
The ClinicalTrials.gov registry entry for NCT01749787 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protalex, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which PRTX-100 at 1.5 mcg/kg is the first listed.
NCT01749787 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01749787 about?
NCT01749787 is a clinical study titled "Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis". The purpose of this study is to determine the safety and tolerability of PRTX-100 when various doses are given 5 times at weekly intervals to patients with active rheumatoid arthritis that are taking methotrexate or leflunomide. The drug is administered in a physician's office via an intravenous inf...
What is the current status of trial NCT01749787?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2012-11. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01749787?
The interventions under investigation include: PRTX-100 at 1.5 mcg/kg (DRUG), PRTX-100 at 3.0 mcg/kg (DRUG), PRTX-100 at 6.0 mcg/kg (DRUG), PRTX-100 at 12.0 mcg/kg (DRUG), PRTX-100 at 240 mcg (DRUG).
Who is sponsoring clinical trial NCT01749787?
This trial is sponsored by Protalex, which has 4 total clinical trials registered on ClinicalTrials.gov.
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