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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.5 mcg/kg | Experimental | PRTX-100 at 1.5 mcg/kg administered via infusion once per week for 5 weeks |
|
| 3.0 mcg/kg | Experimental | PRTX-100 at 3.0 mcg/kg administered via infusion once per week for 5 weeks |
|
| 6.0 mcg/kg | Experimental | PRTX-100 at 6.0 mcg/kg administered via infusion once per week for 5 weeks |
|
| 12.0 mcg/kg | Experimental | PRTX-100 at 12.0 mcg/kg administered via infusion once per week for 5 weeks |
|
| 240 mcg | Experimental | 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 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRTX-100 at 1.5 mcg/kg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number, severity and attribution of relatedness of Adverse Events | Screening up to 53 Weeks |
| Vital Signs and Physical Examinations | Change from baseline in blood pressure, heart rate, body temperature, and physical examination parameters | Screening up to 25 Weeks |
| ECG | Change from baseline in heart rate, PR interval, QT/QTc interval and QRS duration | Screening, first dose, 5th dose, 9 weeks, and 25 weeks |
| Clinical Laboratory Testing | Change from baseline in blood chemistry, hematology, and urinalysis values | Screening up to 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity | Number and percentage of patients attaining an ACR20, ACR50 and ACR70 response at Week 13. Change from baseline in CDAI, RAPID 3, and DAS28-CRP scores. | Screening up to 53 weeks |
| Immunogenicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William E Gannon, M.D. | Protalex, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Protalex Investigative Site | Los Angeles | California | 90036 | United States | ||
| Protalex Investigational Site |
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Placebo administered via infusion once per week for 5 weeks
|
| 420 mcg | Experimental | PRTX-100 at 420 mcg/dose administered via infusion once per week for 5 weeks then once every four weeks for 16 weeks thereafter. |
|
| 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 | Drug | Placebo administered via infusion once per week for 5 weeks |
|
| PRTX-100 at 420 mcg | Drug |
|
|
Proportion of patients sero-positive and/or with titers > 512 at Week 4 and Week 9, the correlation between anti-product antibody and product clearance, and association between anti-product antibodies and adverse events.
| Prior to first dose, and at 4 weeks, 9 weeks, and 25 weeks |
| Pharmacokinetics | Plasma Cmax, AUC0-n, clearance and Vd. | Prior to first dose up to 72 hours after last dose of PRTX-100 |
| Sarasota |
| Florida |
| 34239 |
| United States |
| Protalex Investigational Site | Coeur d'Alene | Idaho | 83814 | United States |
| Protalex Investigational Site | Anderson | Indiana | 46011 | United States |
| Protalex Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Protalex Investigational Site | Salisbury | North Carolina | 28144 | United States |
| Protalex Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| Protalex Investigational Site | Allen | Texas | 75013 | United States |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D013205 | Staphylococcal Protein A |
| ID | Term |
|---|---|
| D000942 | Antigens, Bacterial |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
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