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

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
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
PRTX-100 at 420 mcg
Sponsored by
Protalex, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring arthritis, rheumatoid, methotrexate, leflunomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Protalex Investigative Site
  • Protalex Investigational Site
  • Protalex Investigational Site
  • Protalex Investigational Site
  • Protalex Investigational Site
  • Protalex Investigational Site
  • Protalex Investigational Site
  • Protalex Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

1.5 mcg/kg

3.0 mcg/kg

6.0 mcg/kg

12.0 mcg/kg

240 mcg

Placebo

420 mcg

Arm Description

PRTX-100 at 1.5 mcg/kg administered via infusion once per week for 5 weeks

PRTX-100 at 3.0 mcg/kg administered via infusion once per week for 5 weeks

PRTX-100 at 6.0 mcg/kg administered via infusion once per week for 5 weeks

PRTX-100 at 12.0 mcg/kg administered via infusion once per week for 5 weeks

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 administered via infusion once per week for 5 weeks

PRTX-100 at 420 mcg/dose administered via infusion once per week for 5 weeks then once every four weeks for 16 weeks thereafter.

Outcomes

Primary Outcome Measures

Adverse Events
Number, severity and attribution of relatedness of Adverse Events
Vital Signs and Physical Examinations
Change from baseline in blood pressure, heart rate, body temperature, and physical examination parameters
ECG
Change from baseline in heart rate, PR interval, QT/QTc interval and QRS duration
Clinical Laboratory Testing
Change from baseline in blood chemistry, hematology, and urinalysis values

Secondary Outcome Measures

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.
Immunogenicity
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
Plasma Cmax, AUC0-n, clearance and Vd.

Full Information

First Posted
December 6, 2012
Last Updated
December 18, 2014
Sponsor
Protalex, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01749787
Brief Title
Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis
Acronym
SPARTA
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Protalex, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
arthritis, rheumatoid, methotrexate, leflunomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.5 mcg/kg
Arm Type
Experimental
Arm Description
PRTX-100 at 1.5 mcg/kg administered via infusion once per week for 5 weeks
Arm Title
3.0 mcg/kg
Arm Type
Experimental
Arm Description
PRTX-100 at 3.0 mcg/kg administered via infusion once per week for 5 weeks
Arm Title
6.0 mcg/kg
Arm Type
Experimental
Arm Description
PRTX-100 at 6.0 mcg/kg administered via infusion once per week for 5 weeks
Arm Title
12.0 mcg/kg
Arm Type
Experimental
Arm Description
PRTX-100 at 12.0 mcg/kg administered via infusion once per week for 5 weeks
Arm Title
240 mcg
Arm Type
Experimental
Arm Description
PRTX-100 at 240 mcg/dose administered via infusion once per week for 5 weeks then once every four weeks for 16 weeks thereafter.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered via infusion once per week for 5 weeks
Arm Title
420 mcg
Arm Type
Experimental
Arm Description
PRTX-100 at 420 mcg/dose administered via infusion once per week for 5 weeks then once every four weeks for 16 weeks thereafter.
Intervention Type
Drug
Intervention Name(s)
PRTX-100 at 1.5 mcg/kg
Other Intervention Name(s)
Staphylococcal Protein A, SpA
Intervention Type
Drug
Intervention Name(s)
PRTX-100 at 3.0 mcg/kg
Other Intervention Name(s)
Staphylococcal Protein A, SpA
Intervention Type
Drug
Intervention Name(s)
PRTX-100 at 6.0 mcg/kg
Other Intervention Name(s)
Staphylococcal Protein A, SpA
Intervention Type
Drug
Intervention Name(s)
PRTX-100 at 12.0 mcg/kg
Other Intervention Name(s)
Staphylococcal Protein A, SpA
Intervention Type
Drug
Intervention Name(s)
PRTX-100 at 240 mcg
Other Intervention Name(s)
Staphylococcal Protein A, SpA
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered via infusion once per week for 5 weeks
Intervention Type
Drug
Intervention Name(s)
PRTX-100 at 420 mcg
Other Intervention Name(s)
Staphylococcal Protein A, SpA
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number, severity and attribution of relatedness of Adverse Events
Time Frame
Screening up to 53 Weeks
Title
Vital Signs and Physical Examinations
Description
Change from baseline in blood pressure, heart rate, body temperature, and physical examination parameters
Time Frame
Screening up to 25 Weeks
Title
ECG
Description
Change from baseline in heart rate, PR interval, QT/QTc interval and QRS duration
Time Frame
Screening, first dose, 5th dose, 9 weeks, and 25 weeks
Title
Clinical Laboratory Testing
Description
Change from baseline in blood chemistry, hematology, and urinalysis values
Time Frame
Screening up to 25 weeks
Secondary Outcome Measure Information:
Title
Disease activity
Description
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.
Time Frame
Screening up to 53 weeks
Title
Immunogenicity
Description
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.
Time Frame
Prior to first dose, and at 4 weeks, 9 weeks, and 25 weeks
Title
Pharmacokinetics
Description
Plasma Cmax, AUC0-n, clearance and Vd.
Time Frame
Prior to first dose up to 72 hours after last dose of PRTX-100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E Gannon, M.D.
Organizational Affiliation
Protalex, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Protalex Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Protalex Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Protalex Investigational Site
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Protalex Investigational Site
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Protalex Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Protalex Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Protalex Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Protalex Investigational Site
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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