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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Protalex, Inc.
• Treatments: Leflunomide; Methotrexate

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