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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: Completed Phase 1 study, sponsored by Protalex.
NCT01749787 is a Phase 1 study that has completed, run by Protalex. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number, severity and attribution of relatedness of Adverse Events
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 |
What the finished NCT01749787 record still lists
NCT01749787 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which PRTX-100 at 1.5 mcg/kg is the first listed.
NCT01749787 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01749787's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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