NCT01749787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

December 6, 2012

Last Update Submit

December 18, 2014

Conditions

Arthritis, Rheumatoid

Keywords

arthritisrheumatoidmethotrexateleflunomide

Outcome Measures

Primary Outcomes (4)

  • Adverse Events

    Number, severity and attribution of relatedness of Adverse Events

    Screening up to 53 Weeks

  • Vital Signs and Physical Examinations

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

    Screening up to 25 Weeks

  • ECG

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

    Screening, first dose, 5th dose, 9 weeks, and 25 weeks

  • Clinical Laboratory Testing

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

    Screening up to 25 weeks

Secondary Outcomes (3)

  • Disease activity

    Screening up to 53 weeks

  • Immunogenicity

    Prior to first dose, and at 4 weeks, 9 weeks, and 25 weeks

  • Pharmacokinetics

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

Study Arms (7)

1.5 mcg/kg

EXPERIMENTAL

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

Drug: PRTX-100 at 1.5 mcg/kg

3.0 mcg/kg

EXPERIMENTAL

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

Drug: PRTX-100 at 3.0 mcg/kg

6.0 mcg/kg

EXPERIMENTAL

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

Drug: PRTX-100 at 6.0 mcg/kg

12.0 mcg/kg

EXPERIMENTAL

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

Drug: PRTX-100 at 12.0 mcg/kg

240 mcg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo administered via infusion once per week for 5 weeks

Drug: Placebo

420 mcg

EXPERIMENTAL

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

Interventions

PRTX-100 at 1.5 mcg/kgDRUG
Also known as: Staphylococcal Protein A, SpA
1.5 mcg/kg
PRTX-100 at 3.0 mcg/kgDRUG
Also known as: Staphylococcal Protein A, SpA
3.0 mcg/kg
PRTX-100 at 6.0 mcg/kgDRUG
Also known as: Staphylococcal Protein A, SpA
6.0 mcg/kg
PRTX-100 at 12.0 mcg/kgDRUG
Also known as: Staphylococcal Protein A, SpA
12.0 mcg/kg
PRTX-100 at 240 mcgDRUG
Also known as: Staphylococcal Protein A, SpA
240 mcg
PlaceboDRUG

Placebo administered via infusion once per week for 5 weeks

Placebo
PRTX-100 at 420 mcgDRUG
Also known as: Staphylococcal Protein A, SpA
420 mcg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active RA with disease duration of not less than 6 months
  • Concomitant stable methotrexate or leflunomide therapy

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Protalex Investigative Site

Los Angeles, California, 90036, United States

Location

Protalex Investigational Site

Sarasota, Florida, 34239, United States

Location

Protalex Investigational Site

Coeur d'Alene, Idaho, 83814, United States

Location

Protalex Investigational Site

Anderson, Indiana, 46011, United States

Location

Protalex Investigational Site

Albuquerque, New Mexico, 87102, United States

Location

Protalex Investigational Site

Salisbury, North Carolina, 28144, United States

Location

Protalex Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

Protalex Investigational Site

Allen, Texas, 75013, United States

Location

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

Staphylococcal Protein A

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • William E Gannon, M.D.

    Protalex, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2012

First Posted

December 17, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

US(8)