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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new method of delivering Enbrel, a medication for rheumatoid arthritis (RA), using the Sofusa DoseConnect system, a drug delivery device. The goal is to determine if this method is effective and safe for individuals who have used Enbrel for at least 12 weeks and continue to experience RA symptoms such as joint swelling and tenderness. Participants should already use Enbrel injections regularly and have a history of rheumatoid arthritis that affects daily activities. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking research.

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 prior data suggests that the Sofusa DoseConnect device is safe for delivering Enbrel?

Research has shown that Enbrel (etanercept) is generally safe and has been used for over 10 years to treat moderate to severe rheumatoid arthritis (RA). Studies have found that many patients tolerate it well.

The Sofusa DoseConnect system offers a new method to deliver Enbrel, but the drug itself already has FDA approval for RA, confirming its safety for this condition. However, like any treatment, it may cause side effects, such as reactions at the injection site, infections, or headaches.

This study is in its early stages and primarily focuses on safety, so participants will be closely monitored for any side effects. The use of Enbrel in this trial is supported by existing safety data for RA. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for rheumatoid arthritis, which typically involve injections or pills, Enbrel® is being administered via the Sofusa® DoseConnect™ delivery system. This new method delivers the medication directly through the skin using micro-needles, potentially enhancing absorption and effectiveness. Researchers are excited because this could mean better control of symptoms with lower doses and fewer side effects, offering a more precise and patient-friendly treatment option.

What evidence suggests that Sofusa Enbrel is effective for rheumatoid arthritis?

Research shows that Enbrel, when used with the Sofusa DoseConnect system, effectively reduces joint swelling and slows cartilage damage in people with rheumatoid arthritis (RA). Enbrel, a TNF blocker, targets a protein in the body that causes swelling. Other studies have shown that Enbrel helped 24% of patients become symptom-free and 39% achieve low disease activity. In this trial, participants will receive Enbrel through the Sofusa DoseConnect delivery system. The Sofusa system may deliver Enbrel more directly and effectively to the affected areas. This combination aims to improve results by targeting more of the medication where it’s needed. ^{1 5 6 7 8}

Who Is on the Research Team?

Mike Royal, MD JD MBA

Principal Investigator

Sorrento Therapeutics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04559412

NCT04559412 | Study to Assess the Safety and Efficacy of ... This is an open-label pilot study in patients with rheumatoid arthritis (RA). All patients will receive SOFUSA Enbrel 25 mg once weekly.

2. withpower.com withpower.com/trial/phase-1-arthritis-2021-ca526

Enbrel with Sofusa DoseConnect for 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8964852/

Effectiveness of Etanercept in Rheumatoid Arthritis In this non-interventional study, 24% and 39% of patients with RA treated with ETN as part of routine care in Germany achieved remission and LDA ...

4. enbrelpro.com enbrelpro.com/efficacy/rheumatoid-arthritis

Rheumatoid Arthritis (RA) Efficacy| Enbrel® (etanercept) Primary endpoint results: · ACR results: · Reductions in Pain, Morning Stiffness, and C-Reactive Protein (CRP) · Reductions in HAQ Scores (%) · Percentage of ...

5. ddrare.nibn.go.jp ddrare.nibn.go.jp/ddrare_Mar2023/cgi-bin/drug_who_e.cgi?query=ENBREL&disease_id=46

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

6. enbrel.com enbrel.com/rheumatoid-arthritis

Rheumatoid Arthritis Treatment | ENBREL® (etanercept) Learn about ENBREL® (etanercept) for moderate to severe rheumatoid arthritis (RA). See Full Prescribing & Safety Info.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/103795s5556lbl.pdf

ENBREL (etanercept) - accessdata.fda.gov Enbrel is used to treat: • moderately to severely active rheumatoid arthritis (RA). Enbrel can be used alone or with a medicine called methotrexate ...

8. enbrelpro.com enbrelpro.com/safety/rheumatoid-arthritis

Rheumatoid Arthritis (RA) Safety | Enbrel® (etanercept) Review ENBREL's extensive safety profile, including 10 years of continuous safety data, in treating patients with moderate to severe rheumatoid arthritis (RA).