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NCT Number: NCT01749787

Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat 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.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Protalex Investigative Site, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRTX-100 at 1.5 mcg/kg

Drug

Other names: Staphylococcal Protein A, SpA

PRTX-100 at 3.0 mcg/kg

Drug

Other names: Staphylococcal Protein A, SpA

PRTX-100 at 6.0 mcg/kg

Drug

Other names: Staphylococcal Protein A, SpA

PRTX-100 at 12.0 mcg/kg

Drug

Other names: Staphylococcal Protein A, SpA

PRTX-100 at 240 mcg

Drug

Other names: Staphylococcal Protein A, SpA

Placebo

Drug

Placebo administered via infusion once per week for 5 weeks

PRTX-100 at 420 mcg

Drug

Other names: Staphylococcal Protein A, SpA

Primary outcomes

  1. Adverse Events

    Time frame: Screening up to 53 Weeks

    Number, severity and attribution of relatedness of Adverse Events

  2. Vital Signs and Physical Examinations

    Time frame: Screening up to 25 Weeks

    Change from baseline in blood pressure, heart rate, body temperature, and physical examination parameters

  3. ECG

    Time frame: Screening, first dose, 5th dose, 9 weeks, and 25 weeks

    Change from baseline in heart rate, PR interval, QT/QTc interval and QRS duration

  4. Clinical Laboratory Testing

    Time frame: Screening up to 25 weeks

    Change from baseline in blood chemistry, hematology, and urinalysis values

Secondary outcomes

  1. Disease activity

    Time frame: Screening up to 53 weeks

    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.

  2. Immunogenicity

    Time frame: Prior to first dose, and at 4 weeks, 9 weeks, and 25 weeks

    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.

  3. Pharmacokinetics

    Time frame: Prior to first dose up to 72 hours after last dose of PRTX-100

    Plasma Cmax, AUC0-n, clearance and Vd.

Sponsors and collaborators

Lead sponsor

Protalex, Inc.

Industry

Registry information

Official study 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

Acronym: SPARTA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2012
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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