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.
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
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