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

PHASE1CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
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

Placebo administered via infusion once per week for 5 weeks

DRUG

PRTX-100 at 420 mcg

Trial Locations (8)

16635

Protalex Investigational Site, Duncansville

28144

Protalex Investigational Site, Salisbury

34239

Protalex Investigational Site, Sarasota

46011

Protalex Investigational Site, Anderson

75013

Protalex Investigational Site, Allen

83814

Protalex Investigational Site, Coeur d'Alene

87102

Protalex Investigational Site, Albuquerque

90036

Protalex Investigative Site, Los Angeles

All Listed Sponsors
lead

Protalex, Inc.

INDUSTRY

NCT01749787 - Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter