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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Protalex, Inc.
ClinicalTrials.gov Identifier:
NCT01749787
First received: December 6, 2012
Last updated: August 14, 2014
Last verified: August 2014
  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 240 mcg
Drug: Placebo
Drug: PRTX-100 at 420 mcg
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.


Enrollment: 61
Study Start Date: November 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (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:
  • Staphylococcal Protein A
  • SpA
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:
  • Staphylococcal Protein A
  • SpA
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:
  • Staphylococcal Protein A
  • SpA
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:
  • Staphylococcal Protein A
  • SpA
Experimental: 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.
Drug: PRTX-100 at 240 mcg
Other Names:
  • Staphylococcal Protein A
  • SpA
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
Experimental: 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.
Drug: PRTX-100 at 420 mcg
Other Names:
  • Staphylococcal Protein A
  • SpA

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749787

Locations
United States, California
Protalex Investigative Site
Los Angeles, California, United States, 90036
United States, Florida
Protalex Investigational Site
Sarasota, Florida, United States, 34239
United States, Idaho
Protalex Investigational Site
Coeur d'Alene, Idaho, United States, 83814
United States, Indiana
Protalex Investigational Site
Anderson, Indiana, United States, 46011
United States, New Mexico
Protalex Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
Protalex Investigational Site
Salisbury, North Carolina, United States, 28144
United States, Pennsylvania
Protalex Investigational Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Protalex Investigational Site
Allen, Texas, United States, 75013
Sponsors and Collaborators
Protalex, Inc.
Investigators
Study Director: William E Gannon, 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: August 14, 2014
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 September 30, 2014