6-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera Collection

NCT02330445 | Completed Phase 1 DMC

• 1 other identifier: PRTX-100-105
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Part A Primary Objective To determine the safety of six months of PRTX-100 administration. Part B Primary Objective To obtain antisera from normal volunteers that have developed anti-PRTX-100 antibodies. Secondary Objective(s) To assess rheumatoid arthritis activity during the period of PRTX-100 treatment To evaluate the development of anti-PRTX-100 antibodies To explore feasibility of joint evaluations with ultrasound To explore feasibility of biomarkers as disease markers

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Safety (Analysis of Adverse Events)

  Number, severity, and attribution of relatedness of Adverse Events will be analyzed.

  6 months

Secondary Outcomes (16)

• ACR-28 joint count

  6 months

• Patient's global assessment of disease activity

  6 months

• Patient's assessment of pain VAS

  6 months

• Physician's global assessment of disease activity

  6 months

• MDHAQ - Physical Function

  6 months

Other Outcomes (1)

• Sera Collection

  77 Days

Study Arms (2)

Part A

EXPERIMENTAL

Up to 12 Part A recipients will have rheumatoid arthritis since this was an entry criterion for Study 104. All subjects will be allocated to the single treatment group at a fixed dose of 6 μg/kg of IV PRTX-100. Subjects will receive four weekly doses followed by 5 monthly doses of PRTX-100. Since subjects will be followed for 28 days after their last dose, the total duration of the study is approximately 8 months. Subjects will be evaluated for adverse events, rheumatoid arthritis activity and the development of anti-PRTX-100 antibodies. The feasibility of different assessment methods of disease activity may be explored. Novel methods of joint evaluation will be explored. Adverse events will be evaluated for at least four weeks after the last dose of PRTX-100.

Drug: PRTX-100

Part B

EXPERIMENTAL

Five healthy subjects will be allocated to the single treatment group at a fixed dose of 6 μg/kg of IV PRTX-100. Subjects will receive four weekly doses. All subjects will have a serum collection requiring approximately 600 mL of blood. Since subjects will be followed for 28 days after their last dose, the total duration of the study is approximately 3 months. Subjects will be evaluated for adverse events and the development of anti-PRTX-100 antibodies. Adverse events will be evaluated for at least four weeks after the last dose of PRTX-100.

Drug: PRTX-100

Interventions

PRTX-100 DRUG

6 micrograms PRTX-100 per kilogram of body weight administered via infusion

Also known as: SpA, Staphylococcal Protein A

Part A; Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has completed the written informed consent process
• Received PRTX-100 or placebo in Study 104
• Receiving methotrexate or leflunomide therapy for at least 12 weeks
• Must be on a stable weekly dose of methotrexate (12.5 to 25 mg) or daily leflunomide (10-20 mg/day) by the same route of administration for at least 3 weeks prior to the start of study drug.
• Agrees to notify the investigator when deviating from protocol requirements for concomitant medications
• Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
• Agrees to avoid elective surgery for the full duration of the study
• For female subjects: agrees to avoid pregnancy from 28 days prior to Study Day 0 and for the full duration of the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide.

You may not qualify if:

• Diagnosis of any other inflammatory arthritis (e.g. psoriatic arthritis, spondyloarthropathy, gout)
• ACR Functional Classification IV
• Systemic involvement secondary to rheumatoid arthritis (vasculitis, pulmonary fibrosis or Felty's syndrome. Secondary Sjogren's syndrome is permitted.
• Any receipt of abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, tocilizumab or tofacitinib within 3 weeks of Study Day 0
• Any receipt of infliximab within 6 weeks of Study Day 0
• Any receipt of rituximab or other anti-CD20 antibodies within 12 months of study day 0
• Any receipt of another investigational product within 4 weeks or 4 half-lives whichever is longer prior to Study Day 0
• Hepatitis B surface antigen positive, HIV positive, hepatitis C antibody positive
• Uncontrolled Type 2 Diabetes or Type I diabetes
• Positive urine pregnancy test
• Diagnosis of hepatic cirrhosis
• Urinalysis must reflect no evidence of systemic or local disease process
• Severe anemia, defined as \< 10 g/dL or hematocrit \< 30%
• Evidence of significant active infection
• Shared a residence within the last year with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis

Sponsors & Collaborators

• Protalex, Inc.: lead

Study Sites (1)

Protalex Investigational Site

Coeur d'Alene, Idaho, 83814, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Staphylococcal Protein A

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Officials

• John B McClain, MD

  Protalex, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two parts of recipients are assigned for this Phase I/II open label, single site study. Part A subjects are all who had RA while Part B subjects are healthy volunteers. All subject are allocated to the single treatment group at a fixed dose of 6.0μg/kg of IV PRTX-100.

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 5, 2015
• Study Start: February 1, 2015
• Primary Completion: April 18, 2016
• Study Completion: November 30, 2016
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)