Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis (SPARTA)
This study is currently recruiting participants.
Verified April 2013 by Protalex, Inc.
Sponsor:
Protalex, Inc.
Information provided by (Responsible Party):
Protalex, Inc.
ClinicalTrials.gov Identifier:
NCT01749787
First received: December 6, 2012
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Rheumatoid |
Drug: PRTX-100 at 1.5 mcg/kg Drug: 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 18.0 mcg/kg Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Protalex, Inc.:
Primary Outcome Measures:
- Adverse Events [ Time Frame: Screening up to 53 Weeks ] [ Designated as safety issue: Yes ]Number, severity and attribution of relatedness of Adverse Events
- Vital Signs and Physical Examinations [ Time Frame: Screening up to 25 Weeks ] [ Designated as safety issue: Yes ]Change from baseline in blood pressure, heart rate, body temperature, and physical examination parameters
- ECG [ Time Frame: Screening, first dose, 5th dose, 9 weeks, and 25 weeks ] [ Designated as safety issue: Yes ]Change from baseline in heart rate, PR interval, QT/QTc interval and QRS duration
- Clinical Laboratory Testing [ Time Frame: Screening up to 25 weeks ] [ Designated as safety issue: Yes ]Change from baseline in blood chemistry, hematology, and urinalysis values
Secondary Outcome Measures:
- Disease activity [ Time Frame: Screening up to 53 weeks ] [ Designated as safety issue: No ]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.
- Immunogenicity [ Time Frame: Prior to first dose, and at 4 weeks, 9 weeks, and 25 weeks ] [ Designated as safety issue: No ]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.
- Pharmacokinetics [ Time Frame: Prior to first dose up to 72 hours after last dose of PRTX-100 ] [ Designated as safety issue: No ]Plasma Cmax, AUC0-n, clearance and Vd.
| Estimated Enrollment: | 52 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1.5 mcg/kg
PRTX-100 at 1.5 mcg/kg administered via infusion once per week for 5 weeks
|
Drug: PRTX-100 at 1.5 mcg/kg
Other Names:
|
|
Experimental: 3.0 mcg/kg
PRTX-100 at 3.0 mcg/kg administered via infusion once per week for 5 weeks
|
Drug: PRTX-100 at 3.0 mcg/kg
Other Names:
|
|
Experimental: 6.0 mcg/kg
PRTX-100 at 6.0 mcg/kg administered via infusion once per week for 5 weeks
|
Drug: PRTX-100 at 6.0 mcg/kg
Other Names:
|
|
Experimental: 12.0 mcg/kg
PRTX-100 at 12.0 mcg/kg administered via infusion once per week for 5 weeks
|
Drug: PRTX-100 at 12.0 mcg/kg
Other Names:
|
|
Experimental: 18.0 mcg/kg
PRTX-100 at 18.0 mcg/kg administered via infusion once per week for 5 weeks
|
Drug: PRTX-100 at 18.0 mcg/kg
Other Names:
|
|
Placebo Comparator: Placebo
Placebo administered via infusion once per week for 5 weeks
|
Drug: Placebo
Placebo administered via infusion once per week for 5 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749787
Contacts
| Contact: Derek Wimmer | 816-728-2387 | dwimmer@protalex.com |
Locations
| United States, California | |
| Protalex Investigative Site | Recruiting |
| Los Angeles, California, United States, 90036 | |
| United States, Florida | |
| Protalex Investigational Site | Recruiting |
| Sarasota, Florida, United States, 34239 | |
| United States, Idaho | |
| Protalex Investigational Site | Recruiting |
| Coeur d'Alene, Idaho, United States, 83814 | |
| United States, Pennsylvania | |
| Protalex Investigational Site | Recruiting |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Texas | |
| Protalex Investigational Site | Recruiting |
| Allen, Texas, United States, 75013 | |
Sponsors and Collaborators
Protalex, Inc.
Investigators
| Study Director: | Edward Bernton, M.D. | Protalex, Inc. |
More Information
No publications provided
| Responsible Party: | Protalex, Inc. |
| ClinicalTrials.gov Identifier: | NCT01749787 History of Changes |
| Other Study ID Numbers: | PRTX-100-104 |
| Study First Received: | December 6, 2012 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Food and Drug Administration South Africa: Medicines Control Council |
Keywords provided by Protalex, Inc.:
|
arthritis rheumatoid methotrexate leflunomide |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Leflunomide Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013