Enbrel with Sofusa DoseConnect for Rheumatoid Arthritis

Overseen By Alexis Jefferson, MHA BSN RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sorrento Therapeutics, Inc.

Must be taking: Enbrel

Must not be taking: Biologics, Chlorambucil, Cyclophosphamide, others

Disqualifiers: Cancer, Diabetes, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

11 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you continue taking Enbrel, as participants must already be on Enbrel therapy. If you are taking methotrexate (MTX) or other permitted medications, you must be on a stable dose before starting the trial and continue it during the study. Other medications may need to be stopped or adjusted, but the protocol does not specify all details.

What data supports the effectiveness of the drug Enbrel with Sofusa DoseConnect for treating rheumatoid arthritis?

Research shows that Enbrel, a tumor necrosis factor (TNF) blocker, has been effective in reducing joint inflammation and slowing cartilage damage in rheumatoid arthritis patients. It is often used in combination with other treatments like methotrexate to enhance its effectiveness. ^{1 2 3 4 5}

Is Enbrel with Sofusa DoseConnect safe for humans?

Enbrel (etanercept) has been associated with serious side effects in some cases, as seen in studies of similar treatments for rheumatoid arthritis. While specific safety data for Enbrel with Sofusa DoseConnect isn't provided, it's important to consider these potential risks and discuss them with your doctor. ^{6 7 8 9 10}

How is the drug Enbrel with Sofusa DoseConnect unique for treating rheumatoid arthritis?

Enbrel, a drug that blocks inflammation by inhibiting tumor necrosis factor (TNF), is unique when used with Sofusa DoseConnect because it may offer a novel way of delivering the medication directly through the skin, potentially improving how the drug is absorbed and reducing the need for traditional injections. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Mike Royal, MD JD MBA

Principal Investigator

Sorrento Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with rheumatoid arthritis.

I've been on a stable dose of specific arthritis medications for the required time.

I have been on a stable dose of my RA medication for at least 2 weeks.

Exclusion Criteria

I have no cancer history in the last 5 years, except for treated skin cancer or localized cervical, colon, or bladder conditions.

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

I haven't taken leflunomide in the last 8 weeks, or 4 weeks if I had a cholestyramine washout.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive SOFUSA Enbrel 25 mg once weekly

4 weeks

Dose Escalation

Dose may be increased to 50 mg if criteria are met

4 weeks

Maintenance

Participants remain on either 25 mg or 50 mg dose

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enbrel
• Sofusa DoseConnect

Trial Overview 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.

Participant Groups

Group I: Sofusa Enbrel Experimental Treatment 2 Interventions

Enbrel® administered by the Sofusa® DoseConnect™ delivery system

Who Is Running the Clinical Trial?

Sorrento Therapeutics, Inc.

Lead Sponsor

Trials

48

Recruited

2,000+

Findings from Research

A study analyzing 741 adverse events reported for three biologics (adalimumab, etanercept, and infliximab) in the Portuguese pharmacovigilance system found that all three were significantly associated with increased risks of infections and neoplasms, indicating potential safety concerns.

Adalimumab and etanercept showed strong associations with specific adverse events, while infliximab was linked to a broader range of issues, including immune system disorders and respiratory problems, suggesting that each biologic may have unique safety profiles that require careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profiles of adalimumab, etanercept and infliximab: a pharmacovigilance study using a measure of disproportionality in a database of spontaneously reported adverse events. Mendes, D., Alves, C., Batel-Marques, F.[2015]

Adalimumab has been shown to be generally safe and well tolerated in patients with rheumatoid arthritis, based on safety data from over 10,000 patients and 12,506 patient-years of exposure in clinical trials.

The rate of serious infections was consistent with previous reports, and after implementing tuberculosis screening, the incidence of TB cases decreased significantly, indicating effective monitoring and management of potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Schiff, MH., Burmester, GR., Kent, JD., et al.[2022]

The DANBIO database captured 20 times more adverse events related to biological agents than the Danish Medicines Agency, highlighting its effectiveness in monitoring patient safety.

Infections and hypersensitivity reactions were the most common adverse events, with older age, longer disease duration, and a higher number of previous DMARD treatments identified as risk factors for bacterial infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). Hetland, ML., Unkerskov, J., Ravn, T., et al.[2019]

In a study involving 15,132 patients with rheumatoid arthritis, adalimumab was found to have a well-established safety profile, with serious infections occurring at a low rate of 4.7 events per 100 patient-years and no significant laboratory abnormalities compared to placebo.

The analysis also indicated that pregnancy outcomes for women exposed to adalimumab were similar to those of unexposed women with rheumatoid arthritis and healthy women, with no increased risk of major birth defects or spontaneous abortions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Burmester, GR., Landewé, R., Genovese, MC., et al.[2022]

Enbrel, a soluble tumor necrosis factor (TNF) receptor fusion protein, effectively inhibits TNF's biological effects and has been shown to significantly improve symptoms of rheumatoid arthritis in placebo-controlled trials.

Current clinical trials are evaluating the safety and efficacy of Enbrel in combination with methotrexate for patients with refractory rheumatoid arthritis, as well as comparing its effectiveness to methotrexate in early rheumatoid arthritis cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soluble tumor necrosis factor receptor (p75) fusion protein (ENBREL) as a therapy for rheumatoid arthritis. Moreland, LW.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Is glucocorticoid bridging therapy associated with later use of glucocorticoids and biological DMARDs during the disease course of patients with rheumatoid arthritis in daily practice? A real-world data analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Dosing patterns of three tumor necrosis factor blockers among patients with rheumatoid arthritis in a large United States managed care population. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Effect of Adherence to Protocolized Targeted Intensifications of Disease-modifying Antirheumatic Drugs on Treatment Outcomes in Rheumatoid Arthritis: Results from an Australian Early Arthritis Cohort. [2018]

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How do the biologics fit into the current DMARD armamentarium? [2015]

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Claims Data Analysis of Tumor Necrosis Factor Inhibitor Treatment Dosing Among Patients with Rheumatoid Arthritis: A Systematic Review of Methods. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Safety profiles of adalimumab, etanercept and infliximab: a pharmacovigilance study using a measure of disproportionality in a database of spontaneously reported adverse events. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). [2019]

9. Italy pubmed.ncbi.nlm.nih.gov

Safety of leflunomide plus infliximab combination therapy in rheumatoid arthritis. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. [2022]

11. Singapore pubmed.ncbi.nlm.nih.gov

A comparative study of etanercept plus methotrexate and methotrexate alone in Taiwanese patients with active rheumatoid arthritis: a 12-week, double-blind, randomized, placebo-controlled study. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of leflunomide or methotrexate plus subcutaneous tumour necrosis factor-alpha blocking agents in rheumatoid arthritis. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Soluble tumor necrosis factor receptor (p75) fusion protein (ENBREL) as a therapy for rheumatoid arthritis. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Etanercept and infliximab for rheumatoid arthritis. [2015]

15. England pubmed.ncbi.nlm.nih.gov

Does route of administration affect the outcome of TNF antagonist therapy? [2022]