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

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	3/1/2014
Start Date:	November 2012
End Date:	July 2014
Contact:	Derek Wimmer
Email:	dwimmer@protalex.com
Phone:	816-728-2387

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

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.

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

We found this trial at

sites

Protalex Investigative Site

Mineola, New York 11501

from

Mineola, NY