# Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis

> **NCT01749787** · PHASE1 · COMPLETED · sponsor: **Protalex, Inc.** · enrollment: 61 (actual)

## Conditions studied

- Arthritis, Rheumatoid

## 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
- **DRUG:** Placebo
- **DRUG:** PRTX-100 at 420 mcg

## Key facts

- **NCT ID:** NCT01749787
- **Lead sponsor:** Protalex, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-11
- **Primary completion:** 2014-08
- **Final completion:** 2014-08
- **Target enrollment:** 61 (ACTUAL)
- **Last updated:** 2014-12-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01749787

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01749787, "Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT01749787. Licensed CC0.

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