Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107991
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2005-04-11
Brief Title:
Etanercept for Treatment of Hidradenitis
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Phase II Open Label Clinical Trial of Etanercept for the Treatment of Hidradenitis Suppurativa
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to test a drug called etanercept Enbrel Etanercept has been approved by the US Food and Drug Administration FDA for the treatment of chronic moderate to severe plaque psoriasis PsO for use in reducing the signs and symptoms of moderately to severely active rheumatoid arthritis RA in adults and children and psoriatic arthritis PsA and ankylosing spondylitis AS in adults It is available by prescription for the treatment of PsO RA PsA and AS Etanercept is approved for injection under the skin at a dose of 50 mg per week in patients with psoriasis
The purpose of this study is to determine whether etanercept is safe and effective for the treatment of hidradenitis Another purpose of this study is to determine the impact of etanercept treatment of hidradenitis on skin related to quality of life
The skin lesions typically associated with hidradenitis are thought to be partly due to a blockage that occurs in sweat glands called apocrine ducts which become inflamed and eventually destroyed A protein found in the body called tumor necrosis factor alpha or TNF- α is a hormone that causes this inflammation or swelling The study drug etanercept blocks the action of TNF- α By blocking the action of TNF-α etanercept may provide a reduction in the signs and symptoms of hidradenitis
This study will take place at the University of Pennsylvania and will involve up to 21 participants ages 18 and up Approximately 21 subjects will participate at the University of Pennsylvania
Each patient will participate in this study for a maximum of 6 months The study consists of a screening visit baseline assessment visit Day 1 a treatment period Week 2 - Week 14 and a one month follow-up visit Week 18 visit The total duration of the study will be approximately 2 years
The purpose of this study is to determine whether etanercept is safe and effective for the treatment of hidradenitis Another purpose of this study is to determine the impact of etanercept treatment of hidradenitis on skin related to quality of life
The skin lesions typically associated with hidradenitis are thought to be partly due to a blockage that occurs in sweat glands called apocrine ducts which become inflamed and eventually destroyed A protein found in the body called tumor necrosis factor alpha or TNF- α is a hormone that causes this inflammation or swelling The study drug etanercept blocks the action of TNF- α By blocking the action of TNF-α etanercept may provide a reduction in the signs and symptoms of hidradenitis
This study will take place at the University of Pennsylvania and will involve up to 21 participants ages 18 and up Approximately 21 subjects will participate at the University of Pennsylvania
Each patient will participate in this study for a maximum of 6 months The study consists of a screening visit baseline assessment visit Day 1 a treatment period Week 2 - Week 14 and a one month follow-up visit Week 18 visit The total duration of the study will be approximately 2 years
Detailed Description:
Purpose The primary objective of this study is to determine the safety and estimate the efficacy of etanercept for the treatment of hidradenitis suppurativa The secondary objective of this study is to determine the impact of etanercept treatment of hidradenitis suppurativa on skin related quality of life
Duration
Each patient will participate in this study for a maximum of 6 months The study consists of a screening visit baseline assessment visit Day 1 a treatment period Week 2 - Week 14 and a one month follow-up visit Week 18 visit The total duration of the study will be approximately 2 years
Subject Recruitment and Selection
It is planned that enrollment will be 12-21 patients
Background
Hidradenitis suppurativa is a physically psychologically and socially disabling disease characterized by inflammatory cystic papules and nodules affecting the underarms groin perineum and breasts Lesions can become erosive and often develop deep abscesses and sinus tracts and drain foul smelling pus Left untreated hidradenitis can result in permanent scarring In the most severe cases characterized by chronic ulceration and granulation there may be an increased risk of aggressive squamous cell carcinoma
Current treatment of hidradenitis consists of intra-lesional injections of steroids topical andor systemic antibiotics hormonal therapy and isotretinoin For many patients with severe hidradenitis stage II and III these therapies are often ineffective Patients with stage II and III hidradenitis often require surgical excision of the affected area a highly morbid procedure to control the disease Unfortunately for most patients with hidradenitis existing therapies are ineffective and there is an unmet medical need for therapies that control this disabling and destructive disease
The pathophysiology of hidradenitis is unknown The leading hypothesis is that occlusion of apocrine ducts leads to severe dilatation apocrine gland inflammation with ensuing bacterial growth and neutrophilic infiltration and destruction of the duct The importance of the immune dysregulation in hidradenitis is further demonstrated by its association in many individuals with inflammatory bowel disease
The pathologic immune reaction to follicular occlusion in hidradenitis suggests a strong rationale for the use of treatments that may neutralize this inflammatory reaction In fact the existing standard treatment of hidradenitis is intra-lesional injections of steroids in the effort to minimize the destructive nature of the immune response Medications that are broadly immuno-suppressive such as cyclosporine have also been used to successfully treat hidradenitis but are limited by organ toxicity This rationale is further supported by case reports of dramatic and rapid eg within days improvement in hidradenitis treated with infliximab a monoclonal antibody that blocks TNF-alpha
Etanercept is a TNF-alpha inhibitor currently FDA approved to treat various inflammatory disorders including rheumatoid arthritis psoriatic arthritis and psoriasis By inhibiting TNF-alpha etanercept stops the inflammatory cascade by binding directly to circulating TNF-alpha and inhibiting its binding to cell surface receptors
Etanercept has been used in over 200000 patients world wide for more than 5 years and has a well established safety record The most common adverse effect of etanercept is injection site reaction which is typically mild and self-limited Currently laboratory monitoring for patients being treated with etanercept is not recommended according to its label since the drug has not been associated with a significant incidence of laboratory abnormalities
The well established safety profile of etanercept and its potent role in suppressing pathologic immune responses through TNF-inhibition make it a promising agent for the treatment of hidradenitis suppurativa In this phase II clinical trial we will determine preliminary evidence of safety and estimate the efficacy of etanercept in the treatment of hidradenitis This study will provide critical preliminary data for planning larger pivotal trials
Research Design
This is a phase II open label two-stage clinical trial of etanercept for the treatment of hidradenitis This design is a widely accepted method for early investigations of safety and efficacy of medications for new indications Etanercept 50 mg will be administered subcutaneously once a week for 12 weeks in an open label manner At week 12 the etanercept dose will be tapered to 25 mg subcutaneously once a week for 2 weeks
This is an 18 week study Subjects will be screened to determine eligibility Day -95 to -3 will be a screening period which will allow washout of concurrent therapies if necessary
Potential Risks
Etanercept was generally well tolerated in patients with rheumatoid arthritis psoriatic arthritis and ankylosing spondylitis Adverse events that were reported in at least 3 of all patients with higher incidence in patients treated with etanercept than placebo are
Injection site reaction
Infection
Headache
Nausea
Rhinitis
Dizziness
Pharyngitis
Cough
Asthenia
Abdominal pain
Rash
Peripheral edema
Respiratory disorder
Dyspepsia
Sinusitis
Vomiting
Mouth ulcer
Alopecia
Potential Benefits
No direct benefits from participation in the study can be guaranteed The study medication will be provided by the Financial Sponsor at no charge
Duration
Each patient will participate in this study for a maximum of 6 months The study consists of a screening visit baseline assessment visit Day 1 a treatment period Week 2 - Week 14 and a one month follow-up visit Week 18 visit The total duration of the study will be approximately 2 years
Subject Recruitment and Selection
It is planned that enrollment will be 12-21 patients
Background
Hidradenitis suppurativa is a physically psychologically and socially disabling disease characterized by inflammatory cystic papules and nodules affecting the underarms groin perineum and breasts Lesions can become erosive and often develop deep abscesses and sinus tracts and drain foul smelling pus Left untreated hidradenitis can result in permanent scarring In the most severe cases characterized by chronic ulceration and granulation there may be an increased risk of aggressive squamous cell carcinoma
Current treatment of hidradenitis consists of intra-lesional injections of steroids topical andor systemic antibiotics hormonal therapy and isotretinoin For many patients with severe hidradenitis stage II and III these therapies are often ineffective Patients with stage II and III hidradenitis often require surgical excision of the affected area a highly morbid procedure to control the disease Unfortunately for most patients with hidradenitis existing therapies are ineffective and there is an unmet medical need for therapies that control this disabling and destructive disease
The pathophysiology of hidradenitis is unknown The leading hypothesis is that occlusion of apocrine ducts leads to severe dilatation apocrine gland inflammation with ensuing bacterial growth and neutrophilic infiltration and destruction of the duct The importance of the immune dysregulation in hidradenitis is further demonstrated by its association in many individuals with inflammatory bowel disease
The pathologic immune reaction to follicular occlusion in hidradenitis suggests a strong rationale for the use of treatments that may neutralize this inflammatory reaction In fact the existing standard treatment of hidradenitis is intra-lesional injections of steroids in the effort to minimize the destructive nature of the immune response Medications that are broadly immuno-suppressive such as cyclosporine have also been used to successfully treat hidradenitis but are limited by organ toxicity This rationale is further supported by case reports of dramatic and rapid eg within days improvement in hidradenitis treated with infliximab a monoclonal antibody that blocks TNF-alpha
Etanercept is a TNF-alpha inhibitor currently FDA approved to treat various inflammatory disorders including rheumatoid arthritis psoriatic arthritis and psoriasis By inhibiting TNF-alpha etanercept stops the inflammatory cascade by binding directly to circulating TNF-alpha and inhibiting its binding to cell surface receptors
Etanercept has been used in over 200000 patients world wide for more than 5 years and has a well established safety record The most common adverse effect of etanercept is injection site reaction which is typically mild and self-limited Currently laboratory monitoring for patients being treated with etanercept is not recommended according to its label since the drug has not been associated with a significant incidence of laboratory abnormalities
The well established safety profile of etanercept and its potent role in suppressing pathologic immune responses through TNF-inhibition make it a promising agent for the treatment of hidradenitis suppurativa In this phase II clinical trial we will determine preliminary evidence of safety and estimate the efficacy of etanercept in the treatment of hidradenitis This study will provide critical preliminary data for planning larger pivotal trials
Research Design
This is a phase II open label two-stage clinical trial of etanercept for the treatment of hidradenitis This design is a widely accepted method for early investigations of safety and efficacy of medications for new indications Etanercept 50 mg will be administered subcutaneously once a week for 12 weeks in an open label manner At week 12 the etanercept dose will be tapered to 25 mg subcutaneously once a week for 2 weeks
This is an 18 week study Subjects will be screened to determine eligibility Day -95 to -3 will be a screening period which will allow washout of concurrent therapies if necessary
Potential Risks
Etanercept was generally well tolerated in patients with rheumatoid arthritis psoriatic arthritis and ankylosing spondylitis Adverse events that were reported in at least 3 of all patients with higher incidence in patients treated with etanercept than placebo are
Injection site reaction
Infection
Headache
Nausea
Rhinitis
Dizziness
Pharyngitis
Cough
Asthenia
Abdominal pain
Rash
Peripheral edema
Respiratory disorder
Dyspepsia
Sinusitis
Vomiting
Mouth ulcer
Alopecia
Potential Benefits
No direct benefits from participation in the study can be guaranteed The study medication will be provided by the Financial Sponsor at no charge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0305 | None | None | None |