Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis (SPARTA)
Arthritis, Rheumatoid
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring arthritis, rheumatoid, methotrexate, leflunomide
Eligibility Criteria
Inclusion Criteria:
- Active RA with disease duration of not less than 6 months
- Concomitant stable methotrexate or leflunomide therapy
Exclusion Criteria:
- Diagnosis of any other inflammatory arthritis
- ACR Functional Classification of IV
- Significant systemic involvement secondary to RA (except for secondary Sjogren's syndrome)
- History of clincally significant hypogammaglobulinemia, common variable immunodeficiency, or humeral immunodeficientncy
- History of active tuberculosis, pro-thrombotic disorder, venous thrombosis requiring anti-coagulation, substance abuse, or serious psychiatric condition
- History of allergy or hypersensitivity to aspirin or non-steroidal cyclooxygenase inhibitors, Staphylococcal protein A
- History or presence of malignancy (except for surgically treated basal or squamous cell carcinoma of the skin at least 3 months prior to the start of study medication)
- Uncontrolled diabetes or Type 1 diabetes
- Unstable ischemic heart disease
- Serious active or recurrent infection, hepatic cirrhosis, or other medically unstable condition
- Systemic autoimmune diseases other than RA (such as systemic lupus erythematosus, scleroderma, inflammatory bowel disease, inflammatory myopathy)
- Positive for HIV, hepatitis B surface antigen, or hepatitis C antibody
- Pregnant or nursing females
- Inadequate hepatic, renal, or hematologic function
- Receipt of live vaccine within 5 weeks of start of study medication
- Concomitant administration of other biologic or non-biologic DMARDS, corticosteroids, or anti-CD20 antibodies
Sites / Locations
- Protalex Investigative Site
- Protalex Investigational Site
- Protalex Investigational Site
- Protalex Investigational Site
- Protalex Investigational Site
- Protalex Investigational Site
- Protalex Investigational Site
- Protalex Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
1.5 mcg/kg
3.0 mcg/kg
6.0 mcg/kg
12.0 mcg/kg
240 mcg
Placebo
420 mcg
PRTX-100 at 1.5 mcg/kg administered via infusion once per week for 5 weeks
PRTX-100 at 3.0 mcg/kg administered via infusion once per week for 5 weeks
PRTX-100 at 6.0 mcg/kg administered via infusion once per week for 5 weeks
PRTX-100 at 12.0 mcg/kg administered via infusion once per week for 5 weeks
PRTX-100 at 240 mcg/dose administered via infusion once per week for 5 weeks then once every four weeks for 16 weeks thereafter.
Placebo administered via infusion once per week for 5 weeks
PRTX-100 at 420 mcg/dose administered via infusion once per week for 5 weeks then once every four weeks for 16 weeks thereafter.