Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT01749787. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid Arthritis
Study identification
- NCT ID
- NCT01749787
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Protalex, Inc.
- Industry
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Interventions
- 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
- Placebo Drug
- PRTX-100 at 420 mcg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2012
- Primary completion
- Jul 31, 2014
- Completion
- Jul 31, 2014
- Last update posted
- Dec 22, 2014
2012 – 2014
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Protalex Investigative Site | Los Angeles | California | 90036 | — |
| Protalex Investigational Site | Sarasota | Florida | 34239 | — |
| Protalex Investigational Site | Coeur d'Alene | Idaho | 83814 | — |
| Protalex Investigational Site | Anderson | Indiana | 46011 | — |
| Protalex Investigational Site | Albuquerque | New Mexico | 87102 | — |
| Protalex Investigational Site | Salisbury | North Carolina | 28144 | — |
| Protalex Investigational Site | Duncansville | Pennsylvania | 16635 | — |
| Protalex Investigational Site | Allen | Texas | 75013 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01749787, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 22, 2014 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01749787 live on ClinicalTrials.gov.