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

NCT04559412 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-04-12

No results posted yet for this study

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

Interventions

DEVICE

Sofusa DoseConnect

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

DRUG

Enbrel

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

Sponsors & Collaborators

  • Sorrento Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Mike Royal, MD JD MBA · Sorrento Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2024-01-31
Completion
2024-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04559412 on ClinicalTrials.gov