Etanercept for Tinnitus
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Wayne State University
Must not be taking: Immunomodulatory biologics, Cyclophosphamide, Sulfonylureas, others
Disqualifiers: Diabetes, Seizure disorder, Auto-immune disease, others
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests if Etanercept injections can help adults with noise-induced tinnitus by reducing inflammation. The study aims to see if it can lower tinnitus distress and loudness, and improve hearing.
Will I have to stop taking my current medications?
The trial requires a four-week period without any other tinnitus treatments before starting. Some medications, like cyclophosphamide, sulfasalazine, and certain diabetes and immunomodulatory drugs, are not allowed during the study.
What data supports the effectiveness of the drug Etanercept for treating tinnitus?
Etanercept has been shown to be effective in reducing inflammation in conditions like rheumatoid arthritis and psoriatic arthritis by blocking a protein called TNF-alpha, which is involved in inflammation. While there is no direct evidence for tinnitus, its success in other inflammatory conditions suggests potential benefits.
12345Is Etanercept generally safe for humans?
Etanercept has been shown to be generally safe in humans, with minor side effects like injection site reactions and upper respiratory infections. However, caution is advised as it may reactivate tuberculosis and there are concerns about a potential link to lymphoma.
24567How does the drug Etanercept differ from other treatments for tinnitus?
Etanercept is unique because it is a fusion protein that targets and binds to tumor necrosis factor-alpha (TNF-alpha), a molecule involved in inflammation, which is not a common approach for treating tinnitus. It is typically used for inflammatory conditions like rheumatoid arthritis, and its use for tinnitus is novel, as there are no standard treatments specifically targeting TNF-alpha for this condition.
24568Eligibility Criteria
Adults with moderate to severe tinnitus from noise or blast exposure, or associated with traumatic brain injury (TBI) or concussion. Participants must be stable enough psychologically for the study, not have used other tinnitus treatments in the last four weeks, and able to consent. All hearing levels are included but those with profound loss can't do certain tests.Inclusion Criteria
Able to provide written informed consent.
People with any level of hearing ability can join the study. However, individuals with severe hearing loss won't be able to do certain hearing tests.
Able to provide written informed consent
+34 more
Exclusion Criteria
I am not currently taking abatacept, cyclophosphamide, sulfasalazine, or similar medications.
You currently have a problem with drugs or alcohol.
I am a woman of child-bearing age not using contraception or I am breastfeeding.
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either Etanercept or placebo injections weekly
12 weeks
12 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Exploratory
Exploratory investigations to identify factors influencing therapeutic effects
36 weeks
Participant Groups
The trial is testing Etanercept (Enbrel), a medication given through injections, against a placebo (saline solution). The goal is to see if Etanercept can reduce the severity of tinnitus caused by loud noises or blasts. Participants will be randomly assigned to receive either Etanercept or placebo.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Etanercept Injection GroupExperimental Treatment1 Intervention
Subjects will receive 2 X 25mg/ 1ml etanercept injection (experimental) weekly for 12 weeks.
Group II: Placebo Injection GroupPlacebo Group1 Intervention
Subjects will receive 2 X 1ml saline injection (placebo) weekly for 12 weeks.
Etanercept is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Enbrel for:
- Moderate to Severe Rheumatoid Arthritis
- Moderate to Severe Polyarticular Juvenile Rheumatoid Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Moderate to Severe Plaque Psoriasis
🇪🇺 Approved in European Union as Enbrel for:
- Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Plaque Psoriasis
🇨🇦 Approved in Canada as Enbrel for:
- Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Plaque Psoriasis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of IowaIowa City, IA
Madigan Army Medical CenterTacoma, WA
University of Arizona-AHSC BldgTucson, AZ
University of Illinois at Urbana-ChampaignChampaign, IL
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Wayne State UniversityLead Sponsor
University of IowaCollaborator
United States Naval Medical Center, San DiegoCollaborator
University of MiamiCollaborator
Michigan Ear InstituteCollaborator
Madigan Army Medical CenterCollaborator
Portland VA Medical CenterCollaborator
References
Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial. [2022]We evaluated etanercept, a human soluble tumor necrosis factor receptor: Fc fusion protein, for the treatment of active Crohn's disease.
Construction and purification of the murine p75-murine IgG1 fusion protein. [2016]Etanercept (Amgen Inc, Thousand Oaks, CA) is a human soluble p75 tumor necrosis factor (TNF) receptor-human-IgG1 (hup75 TNFR-huIgG1) fusion protein used in the treatment of chronic inflammatory diseases in humans, including rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. To be able to study the effects of the soluble receptor fusion protein in mouse models, including those that mimic human granulomatous infections, a murine soluble p75-TNF receptor-murine IgG1 (murine p75-murine IgG1) fusion protein had to be constructed. This article discusses the generation, large-scale production, and purification of this molecule.
[Recombinant human tumor necrosis factor receptor type Ⅱ-IgG Fc fusion protein for treatment of occupational medicamentosa-like dermatitis induced by trichloroethylene]. [2019]Objective: To investigate the efficacy and safety of the recombinant human tumor necrosis factor receptor Ⅱ-IgG Fc fusion protein (rhTNFR: Fc, etanercept) for the treatment of occupational medicamentosa-like dermatitis induced by trichloroethylene (OMLDT) . Methods: In September 2011 to February 2016, 12 patients with OMLDT were treated with etanercept 25 mg, subcutaneous injection, twice per week, doubling of first dose. The course of treatment was 6 weeks. The drug eruption area and severity index (DASI) score, the proportion of patients achieving a 50%, 75% and 90% reduction in DASI (DASI50, DASI75, DASI90) and the serum level of TNF-α were used to assess the efficacy at different times. Adverse reactions were also recorded and evaluated. The results were statistically analyzed by nonparametric Friedman test and repetitive measurement ANOVA using the software SPSS19.0. Results: After 4 weeks treatment, the DASI score decreased form 56.33±7.02 to 0.50±0.91 (P<0.01) . The DASI50, DASI75 and DASI90 were all increased to 12 (100%) . The serum level of TNF-α decreased form (43.74±41.62) pg/ml to (3.03±0.47) pg/ml (P<0.01) . Statistically significant difference was observed from the above indexes. There were no adverse reactions in clinical application. Conclusion: Recombinant human tumor necrosis factor receptor Ⅱ-IgG Fc fusion protein may be a safe and effective drug in the treatment of OMLDT.
Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. [2022]In a phase II study, etanercept (recombinant human tumor necrosis factor receptor [p75]:Fc fusion protein) safely produced rapid, dose-dependent improvement in rheumatoid arthritis over 3 months.
Etanercept in arthritis. [2015]Tumour necrosis factor-alpha (TNF-alpha) is one of the inflammatory cytokines. It is released by activated monocytes, macrophages and T lymphocytes and promotes inflammation. TNF-alpha binds to two receptors; one of these is the type 2 TNF receptor (p75). Etanercept is a soluble TNF-receptor fusion protein. It consists of two linked dimmers, each with a ligand-binding portion of the higher affinity type 2 TNF receptor (p75). This fusion protein binds to TNF-alpha and prevents it from interacting with its receptor. Etanercept is given by subcutaneous administration at a dose of 25 mg twice a week. This dosing reflects its half-life of about 4 days. Clinical trials show etanercept is effective and safe to use in rheumatoid arthritis (RA). It reduces disease activity and limits progressive joint damage in both early and late disease. It can be used as a monotherapy or in combination with methotrexate, and in this, the latter approach appears most effective. It is also effective in psoriatic arthritis and ankylosing spondylitis. Although the biologic appears safe, caution is needed to ensure it does not re-activate tuberculosis. It should not be used in patients with disseminated sclerosis, and there are concerns about a potential relationship to lymphoma. Its high cost means there will be continuing debate about the ideal position of this new biologic within the treatment pathway of RA. At present, it is recommended for use when methotrexate and another disease-modifying drug have failed.
Etanercept and urticaria in patients with juvenile idiopathic arthritis. [2017]Etanercept, a tumor necrosis factor receptor p75 Fc fusion protein (TNFR:Fc; Enbrel), has preliminarily been shown to be effective in the management of methotrexate-resistant polyarticular juvenile idiopathic arthritis (JIA). Reported side-effects have been minor, for example injection site reactions and upper respiratory tract infections, not necessitating discontinuation of the medication (1, 2). We report on 2 patients who developed an urticaria-like rash with prurigo appearing bilaterally on the extensor surfaces of the elbows subsequent to etanercept injections.
Pharmacodynamic effects of the murine p75-Fc fusion protein in mice. [2016]Overproduction of inflammatory mediators, such as tumor necrosis factor (TNF), is key to the development and maintenance of inflammatory processes. Etanercept is a soluble TNF receptor fusion protein used in the treatment of various chronic inflammatory diseases, including rheumatoid arthritis and psoriasis. This study investigated the effects of murine p75-Fc, a soluble TNF receptor protein, on TNF-induced IL-6 production in mice. Six groups of mice received either murine p75-Fc (0.15, 0.50, 1.5, 5, and 15 mg/kg) or phosphate-buffered saline. Three days later, mice were injected intravenously with 10 microg of murine TNF and blood samples were taken after 3 hours. Serum IL-6 and TNF were measured by ELISA. Mice treated with 5 and 15 mg/kg murine p75-Fc demonstrated complete inhibition of TNF-induced IL-6 production. Murine p75-Fc (1.5 mg/kg) resulted in a partial but significant reduction of TNF-induced IL-6 production. No TNF was detected in 5 and 15 mg/kg murine p75-Fc-treated mice, except one in the 5 mg/kg dose group. In conclusion, murine p75-Fc completely inhibits TNF-induced IL-6 production in mice.
Use of etanercept in human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) patients. [2015]Etanercept (Enbrel, Amgen, Thousand Oaks, CA), a soluble p75 tumor necrosis factor receptor:FC (TNFR:FC) fusion protein for plasma cytokines, specifically tumor necrosis factor-alpha (TNF-alpha), is used in the treatment of immune-mediated rheumatic diseases. To our knowledge, the use of etanercept in patients with human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) is relatively uncommon.