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Tumor Necrosis Factor (TNF) Blocker

Enbrel with Sofusa DoseConnect for Rheumatoid Arthritis

Phase 1
Waitlist Available
Research Sponsored by Sorrento Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Swollen joint count ≥ 3 (28-joint count) and Tender joint count ≥ 3 (28-joint count) at Screening and Baseline
Has rheumatoid arthritis (RA) as defined by having a score of 6 or higher on the 2010 ACR-EULAR classification criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights

Study Summary

This trial is testing a new way of giving Enbrel to people with RA. All patients will start with a low dose of Enbrel, and if it's well tolerated, the dose will be increased.

Who is the study for?
This trial is for adults with rheumatoid arthritis who've been on Enbrel therapy weekly for at least 12 weeks. They should have a moderate disease activity score, stable medication doses, and agree to contraception if applicable. Exclusions include lack of response to Enbrel, recent use of other biologics or certain drugs, various medical conditions including severe infections or cancer within the last five years.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of administering Enbrel through Sofusa DoseConnect in patients with rheumatoid arthritis. Initially given as a 25 mg dose once weekly, it may increase to 50 mg based on specific criteria during the trial's escalation phase.See study design
What are the potential side effects?
Potential side effects from using Sofusa DoseConnect with Enbrel might include injection site reactions like redness or pain, increased risk of infections due to immune system suppression, allergic reactions, headaches, and possible skin issues related to device adhesive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least 3 swollen and 3 tender joints.
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I have been diagnosed with rheumatoid arthritis.
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I have been diagnosed with rheumatoid arthritis.
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I have been on Enbrel therapy, taking it weekly for at least 12 weeks with no more than 1 missed dose.
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I have been diagnosed with rheumatoid arthritis.
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I have been on Enbrel therapy for at least 12 weeks with no more than 1 missed dose.
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I've been on a stable dose of my rheumatoid arthritis medication for the required time.
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I have at least 3 swollen and 3 tender joints.
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I agree to use birth control during and for 3 months after the study.
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I have been on a stable dose of my RA medication for at least 2 weeks.
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My condition meets specific disease criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events and their relationships to SOFUSA administration
Secondary outcome measures
Change in Clinical Disease Activity Index (CDAI) score over time
Change in DAS28(CRP) score over time
Change in Disease Activity Score 28-joint count C reactive protein (DAS28(CRP))
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sofusa EnbrelExperimental Treatment2 Interventions
Enbrel® administered by the Sofusa® DoseConnect™ delivery system
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enbrel
2000
Completed Phase 4
~4630

Find a Location

Who is running the clinical trial?

Sorrento Therapeutics, Inc.Lead Sponsor
47 Previous Clinical Trials
2,013 Total Patients Enrolled
Mike Royal, MD JD MBAStudy DirectorSorrento Therapeutics

Media Library

Enbrel (Tumor Necrosis Factor (TNF) Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04559412 — Phase 1
Rheumatoid Arthritis Research Study Groups: Sofusa Enbrel
Rheumatoid Arthritis Clinical Trial 2023: Enbrel Highlights & Side Effects. Trial Name: NCT04559412 — Phase 1
Enbrel (Tumor Necrosis Factor (TNF) Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04559412 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this research permissible for minors?

"Within the scope of this medical trial, enrollees must be over 18 years old and under 80."

Answered by AI

Has the FDA ratified Sofusa DoseConnect for medicinal use?

"As this clinical trial is in Phase 1, meaning there is a scarcity of safety and efficacy data, our team at Power assigned Sofusa DoseConnect the lowest possible score on the scale: one."

Answered by AI

What conditions can Sofusa DoseConnect be used to treat?

"Sofusa DoseConnect is an appropriate treatment for moderate to severe conditions, such as disease, rheumatoid arthritis and ankylosing spondylitis."

Answered by AI

Could you elaborate on the research that has been conducted concerning Sofusa DoseConnect?

"Currently, there are 34 ongoing investigations into Sofusa DoseConnect with 10 trials in their final phase. Of those 662 trial sites across the world, several of them can be found in Xi'an, Shaanxi."

Answered by AI

What is the participant capacity of this experimental trial?

"Affirmative. Clinicaltrials.gov shows that this clinical trial is open for enrollment and was first published on October 1st 2022, with a recent update of September 7th 2022. A total of 10 volunteers will be needed from one location to complete the study."

Answered by AI

Do I fulfill the requirements to enroll in this medical experiment?

"This clinical trial is recruiting 10 individuals with rheumatoid arthritis aged between 18 and 80. To be eligible, applicants must meet the following criteria: they should have been taking oral or subcutaneous methotrexate (up to 25 mg/week) or other authorised conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs), such as leflunomide, hydroxychloroquine, sulfasalazine for at least 12 weeks before enrolling in the study; if on methotrexate treatment, a stable dose of folic acid supplements must have been taken over the same period prior to"

Answered by AI

Do you still have availability for participation in this experiment?

"According to the clinicaltrials.gov portal, this trial is actively looking for participants and began accepting applications on October 1st 2022. The study was last updated 7th September of that same year."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Atlanta Research Center for Rheumatology
What portion of applicants met pre-screening criteria?
Met criteria
~3 spots leftby Mar 2025