What side effects are associated with this type of intervention?

The most common treatments for Rheumatoid Arthritis, particularly TNF inhibitors like Enbrel (etanercept), can have several side effects. These include increased risk of infections, injection site reactions, and potential development of autoimmune conditions. Methotrexate, another common RA treatment, can cause liver toxicity, gastrointestinal issues, and bone marrow suppression. Other biologics may also lead to similar risks of infections and infusion reactions. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several TNF inhibitors for the treatment of Rheumatoid Arthritis, including etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), certolizumab (Cimzia), and golimumab (Simponi). These biologic agents work by inhibiting tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation. Etanercept, similar to the SOFUSA Enbrel being studied, is one of the widely used TNF inhibitors and has shown efficacy in reducing symptoms and slowing disease progression in RA patients.

What other types of research exist?

Promising novel alternatives to SOFUSA Enbrel for Rheumatoid Arthritis patients in 2024 include ixekizumab (an anti-IL-17A monoclonal antibody), golimumab, certolizumab (both TNF antagonists), and ustekinumab (an anti-IL-12/23 monoclonal antibody). These agents have shown efficacy in clinical trials and offer different mechanisms of action compared to traditional TNF inhibitors.

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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

Has rheumatoid arthritis (RA) as defined by having a score of 6 or higher on the 2010 ACR-EULAR classification criteria

Swollen joint count ≥ 3 (28-joint count) and Tender joint count ≥ 3 (28-joint count) at Screening and Baseline

Must not have

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

Chronic arthritis diagnosis before the age of 17 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new method of giving Enbrel using the SOFUSA system for RA patients who haven't responded well to usual treatments. The SOFUSA system delivers the drug directly through the skin to improve its effectiveness and reduce side effects. Enbrel was the first biological treatment and the first tumour necrosis factor inhibitor approved for use in rheumatic diseases.

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.

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.

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 been diagnosed with rheumatoid arthritis.

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I have at least 3 swollen and 3 tender joints.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been taking more than 30 mg/day of opioids for most of the past week.

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I was diagnosed with arthritis before I turned 17.

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I have not had joint surgery in the last 8 weeks.

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I have been diagnosed with or shown signs of a disease that affects the protective covering of my nerves.

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I have symptoms of RA outside my joints, excluding nodules.

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I have a history of serious blood, kidney, or liver conditions.

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I haven't used any corticosteroid injections in the last 4 weeks.

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I have taken more than 10 mg/day of steroids in the last 4 weeks.

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I have been treated with more than two types of specific arthritis medications.

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My rheumatoid arthritis is severely disabling.

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I have not received any blood products in the last 12 weeks.

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I haven't had any live vaccines in the last 8 weeks and don't need any during the study.

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I have had infections like histoplasmosis or listeriosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

TNF inhibitors, such as Enbrel (etanercept), work by targeting and neutralizing tumor necrosis factor-alpha (TNF-α), a key pro-inflammatory cytokine involved in the inflammatory processes of Rheumatoid Arthritis (RA). By inhibiting TNF-α, these treatments reduce inflammation, prevent joint damage, and improve physical function. This mechanism is vital for RA patients as it helps manage symptoms, slows disease progression, and enhances overall quality of life.