Study to Assess the Safety and Efficacy of Enbrel Administered by Sofusa DoseConnect for Rheumatoid Arthritis

NCT04559412 | Unknown Phase 1 FDA Drug FDA Device

• 1 other identifier: STI-SOFUSA-1003
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label pilot study in patients with rheumatoid arthritis (RA). All patients will receive SOFUSA Enbrel 25 mg once weekly. The dose will be increased to 50 mg if the dose escalation criteria are met during the dose escalation phase of the study.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events and their relationships to SOFUSA administration

  Incidence and severity of adverse events and their relationships to SOFUSA administration

  Baseline through Week 12

Secondary Outcomes (12)

• Change in Disease Activity Score 28-joint count C reactive protein (DAS28(CRP))

  Baseline to Week 12

• Change in DAS28(CRP) score over time

  Baseline through Week 12

• Change in Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28(ESR)) over time

  Baseline through Week 12

• Change in Simplified Disease Activity Index (SDAI) score over time

  Baseline through Week 12

• Change in Clinical Disease Activity Index (CDAI) score over time

  Baseline through Week 12

Study Arms (1)

Sofusa Enbrel

EXPERIMENTAL

Enbrel® administered by the Sofusa® DoseConnect™ delivery system

Device: Sofusa DoseConnect; Drug: Enbrel

Interventions

Sofusa DoseConnect DEVICE

25 to 50 mg Enbrel® administered by the Sofusa® DoseConnect™ delivery system once weekly for 12 weeks

Also known as: sofusa

Sofusa Enbrel

Enbrel DRUG

25 to 50 mg Enbrel® administered by the Sofusa® DoseConnect™ delivery system once weekly for 12 weeks

Sofusa Enbrel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provides written informed consent
• Has rheumatoid arthritis (RA) as defined by having a score of 6 or higher on the 2010 ACR-EULAR classification criteria
• Is currently on Enbrel therapy and has received once-weekly Enbrel injections for at least 12 weeks with no more than 1 missed dose in the 12 weeks prior to Screening.
• Must meet the following disease criteria:
• Have a DAS28(CRP) score \> 2.9 at Screening Have a DAS28(ESR) score \> 3.2 at Screening Swollen joint count ≥ 3 (28-joint count) and Tender joint count ≥ 3 (28-joint count) at Screening and Baseline
• If on oral or subcutaneous MTX (up to 25 mg/week) or other permitted oral conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) (i.e., leflunomide, up to 20 mg/day; hydroxychloroquine, up to 400 mg/day; or sulfasalazine, up to 3 g/day), must be on stable dose (MTX ≥ 12 weeks and other permitted DMARDs ≥ 8 weeks) within the specified ranges prior to Baseline. Note: if on methotrexate (MTX), subjects must be on a stable dose of folic acid (total ≥ 5 mg per week for ≥ 12 weeks) prior to Baseline and must continue a stable dose during the course of the study.
• If taking regular nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, paracetamol/acetaminophen, or oral glucocorticoids for treatment of RA symptoms, must be on stable dose and route of administration for at least 2 weeks before Baseline
• Females of childbearing potential must agree to use acceptable method(s) of contraception for the duration of the study and for 3 months after the last dose of study drug

You may not qualify if:

• Has participated in a clinical trial with a drug or device within 30 days prior to Screening
• Prior treatment with investigational therapy within 30 days or 5 half-lives before Screening (whichever is longer)
• History of hypersensitivity to any recombinant protein drugs or any of the excipients used in Enbrel
• Has skin contact sensitivities (due to SOFUSA device adhesive) or allergies to iodine (due to the iodine in ICG)
• Lack of any clinical response to Enbrel in the Investigator's opinion
• Treatment with other biologic agents (e.g., interleukin \[IL\] 6, IL17, IL12/23 inhibitors; abatacept, tumor necrosis factor \[TNF\] inhibitors) besides Enbrel within 24 weeks before Baseline
• Previous treatment with more than 2 other tumor necrosis factor (TNF) inhibitor therapies (besides Enbrel), more than 2 targeted therapies with different mechanisms of action (e.g., Janus kinase inhibitors, T cell costimulation inhibitor, IL-6 receptor antagonist), or any cell depleting agents (e.g., anti-CD20)
• Use of chlorambucil or cyclophosphamide within 24 weeks of Baseline
• Use of leflunomide within 8 weeks of Baseline, if washing out of leflunomide, unless a cholestyramine washout has been performed, then use of leflunomide within 4 weeks of Baseline
• Use of MTX, hydroxychloroquine, or sulfasalazine within 4 weeks of Baseline, if washing out of MTX, hydroxychloroquine, or sulfasalazine
• Any systemic nonbiologic DMARD (e.g., Janus kinase inhibitor, cyclosporine, azathioprine) within 4 weeks of Baseline
• History of or ongoing inflammatory, autoimmune, or painful musculoskeletal diseases (except for Sjogren's syndrome or fibromyalgia) which could interfere with the RA assessments as determined by the Investigator
• Functional RA status of class IV according to the ACR 1991 revised criteria at Screening or Baseline
• Oral glucocorticoids \> 10 mg/day prednisone equivalent within 4 weeks prior to Baseline
• Opioid tolerant: defined as the use of opiate analgesics at a dose of \> 30 mg/day of oral morphine equivalent on 4 of the last 7 days prior to Baseline

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (1)

Atlanta Research Center for Rheumatology

Atlanta, Georgia, 30060, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

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)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Mike Royal, MD JD MBA

  Sorrento Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 22, 2020
• Study Start: March 15, 2021
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

US (1)