Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis
NCT ID: NCT01749787
Last Updated: 2014-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2012-11-30
2014-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1.5 mcg/kg
PRTX-100 at 1.5 mcg/kg administered via infusion once per week for 5 weeks
PRTX-100 at 1.5 mcg/kg
3.0 mcg/kg
PRTX-100 at 3.0 mcg/kg administered via infusion once per week for 5 weeks
PRTX-100 at 3.0 mcg/kg
6.0 mcg/kg
PRTX-100 at 6.0 mcg/kg administered via infusion once per week for 5 weeks
PRTX-100 at 6.0 mcg/kg
12.0 mcg/kg
PRTX-100 at 12.0 mcg/kg administered via infusion once per week for 5 weeks
PRTX-100 at 12.0 mcg/kg
240 mcg
PRTX-100 at 240 mcg/dose administered via infusion once per week for 5 weeks then once every four weeks for 16 weeks thereafter.
PRTX-100 at 240 mcg
Placebo
Placebo administered via infusion once per week for 5 weeks
Placebo
Placebo administered via infusion once per week for 5 weeks
420 mcg
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 420 mcg
Interventions
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PRTX-100 at 1.5 mcg/kg
PRTX-100 at 3.0 mcg/kg
PRTX-100 at 6.0 mcg/kg
PRTX-100 at 12.0 mcg/kg
PRTX-100 at 240 mcg
Placebo
Placebo administered via infusion once per week for 5 weeks
PRTX-100 at 420 mcg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Concomitant stable methotrexate or leflunomide therapy
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Protalex, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William E Gannon, M.D.
Role: STUDY_DIRECTOR
Protalex, Inc.
Locations
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Protalex Investigative Site
Los Angeles, California, United States
Protalex Investigational Site
Sarasota, Florida, United States
Protalex Investigational Site
Coeur d'Alene, Idaho, United States
Protalex Investigational Site
Anderson, Indiana, United States
Protalex Investigational Site
Albuquerque, New Mexico, United States
Protalex Investigational Site
Salisbury, North Carolina, United States
Protalex Investigational Site
Duncansville, Pennsylvania, United States
Protalex Investigational Site
Allen, Texas, United States
Countries
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Other Identifiers
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PRTX-100-104
Identifier Type: -
Identifier Source: org_study_id