Hidradenitis SuppurativaPhase 2NCT00107991
Etanercept for Treatment of Hidradenitis
A Phase 2 study testing etanercept in people with Hidradenitis Suppurativa, run by University of Pennsylvania.
Trial summary
This study is being done to test a drug called etanercept (Enbrel®). Etanercept has been approved by the U.S. 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be able to give informed consent.
- Severe hidradenitis suppurativa clinically confirmed by the investigator and defined as recurrent abscesses, with 4 or more lesions (e.g. nodules or abscesses) with sinus track and scar formation (e.g. Stage II or III disease) that has not responded to previous standard therapies such as topical or oral antibiotics, or intralesional injections of steroids.
- Age 18 or older.
- Willingness to use at least one form of effective contraception during the study period and for one month after discontinuation of etanercept if female and of child bearing capacity or if male. If the patient elects to use a hormonal form of contraception then the patient must be on the same form of hormonal contraception for 90 days prior to the start of Etanercept and must plan to continue using the same form of hormonal contraception for the duration of the study (e.g. until week 18).
Who cannot join
- Use of oral or topical antibiotics, isotretinoin, or intralesional steroids within 30 days prior to day 0 or at any time during the study treatment period.
- Use of systemic immunosuppressants within 90 days prior to day 0 of this study.
- Use of an investigational medication 90 days prior to day 0 of this study.
- Use of a live vaccine 90 days prior to day 0 of this study.
- Any previous use of TNF- α inhibitors.
- If using a hormonal form of contraception, the patient will be excluded if they have not used the same form of hormonal contraception for 90 days prior to the start of the etanercept (e.g. day 0) or are not willing to continue the use of the same form of hormonal contraception for the duration of the study.
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- Active infection within 30 days of day 0 of the study that is moderate (discomfort sufficient to reduce or affect normal daily activity) or severe (incapacitating with inability to work or perform normal daily activities) or requires treatment with antibiotics.
- History of tuberculosis or other mycobacterial disease or positive screening visit purified protein derivative (PPD) (≥ 5 mm).
- Known history of an immuno-suppressing disease (e.g. HIV)
- Clinically significant abnormality in liver function, renal function, chemistry panel or complete blood count (CBC) (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times the laboratory's upper limit of normal, hemoglobin < 10.0 g/dL, platelet count <125,000/cm3, white blood count <3,500 cells/cm3 or > 15,000 cells/cm3, or serum creatinine ≥ 2.0 mg/dL) or severe co-morbidities defined as diabetes mellitus requiring insulin, congestive heart failure, history of myocardial infarction, unstable angina, uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure >110 mmHg), severe pulmonary disease (requiring oxygen therapy), history of cancer within 5 years (other than resected basal cell or squamous cell carcinoma and in situ cervical cancer), known history of active hepatitis B or C or HIV infection, history of demyelinating diseases or lupus.
- Pregnancy or lactation
- History of alcohol or drug abuse within 12 months of screening visit
About this study
Official title: A Phase II Open Label Clinical Trial of Etanercept for the Treatment of Hidradenitis Suppurativa
This study is being done to test a drug called etanercept (Enbrel®). Etanercept has been approved by the U.S. 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.
Read more
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.
Read the 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 and/or 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 (e.g. 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 200,000 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- etanercept
- Keywords
- clinical trial; efficacy; etanercept; hidradenitis suppurativa; quality of life; safety; tnf
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
Also called Enbrel
etanercept 50 mg/week subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Open-label treatment with etanercept 50 mg/week subcutaneous injection Receives: Drug: etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% Reduction in Physician's Global Assessment Score (Percent of Participants)
Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks.
PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease.
Measured: 12 weeks
Secondary outcomes (4)
50% Reduction in Number of Lesions (Percent of Participants)
A physician assessed number of lesions as baseline and week 12. Responders were defined as those achieving at least a 50% reduction in number of lesions. A response rate was calculated as percentage of patients classified as responders.
Measured: 12 weeks
Patient Global Assessment
The Patient Global Assessment asked patients to rate the extent of hidradenitis activity compared to when the patient started treatment with etanercept (day 0 of study). The scale included a selection of:
Much worse than before treatment Moderately worse (about 50% more disease activity) A little worse Same A little improved Moderately improved (about 50% reduction in disease activity) Much better than before treatment (no active disease or almost no active disease)
Measured: 12 weeks
Patient's Pain Score
Patient's were asked to self-report their pain on a 100-mm visual analog scale (with 0 corresponding to no pain and 100 mm corresponding to severe pain). Responders were defined as those achieving at least a 50% reduction in pain score from baseline to week 12. Response rate was calculated as the percentage of patients classified as responders.
Measured: 12 weeks
Dermatology Life Quality Index Score (DLQI)
The DLQI is a dermatology-specific health-related quality of life measure. The effect on a patient's life is as follows: 0-1=none; 2-5=small; 6-10=moderate; 11-20=very large; and 21-30=extremely large. Responders were defined as those who achieved a 50% improvement in the DLQI score.
Response rates were calculated as the percentage of participants achieving a response.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2005 (estimated)
- Study startApr 2005
- Primary completionAug 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Gelfand, University of Pennsylvania
- Investigators
- Joel Gelfand, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107991
- Sponsor's protocol ID
- 802687
- Other IDs
- 0305
- Status last verified
- Mar 2018
- First submitted
- 11 Apr 2005
- Last updated
- 21 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lee RA, Dommasch E, Treat J, Sciacca-Kirby J, Chachkin S, Williams J, Shin DB, Leyden JJ, Vittorio C, Gelfand JM. A prospective clinical trial of open-label etanercept for the treatment of hidradenitis suppurativa. J Am Acad Dermatol. 2009 Apr;60(4):565-73. doi: 10.1016/j.jaad.2008.11.898. Epub 2009 Jan 31.
PubMed 19185954
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Clinical Trial of Etanercept for the Treatment of Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT00107991
- Acronym / sponsor ID
- 802687
- Conditions
- Hidradenitis Suppurativa
- Keywords
- clinical trial; efficacy; etanercept; hidradenitis suppurativa; quality of life; safety; tnf
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Apr 2005 (estimated)
- Results
- Posted 14 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to test a drug called etanercept (Enbrel®). Etanercept has been approved by the U.S. 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.
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 and/or 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 (e.g. 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 200,000 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: etanerceptOpen-label treatment with etanercept 50 mg/week subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be able to give informed consent.
- Severe hidradenitis suppurativa clinically confirmed by the investigator and defined as recurrent abscesses, with 4 or more lesions (e.g. nodules or abscesses) with sinus track and scar formation (e.g. Stage II or III disease) that has not responded to previous standard therapies such as topical or oral antibiotics, or intralesional injections of steroids.
- Age 18 or older.
- Willingness to use at least one form of effective contraception during the study period and for one month after discontinuation of etanercept if female and of child bearing capacity or if male. If the patient elects to use a hormonal form of contraception then the patient must be on the same form of hormonal contraception for 90 days prior to the start of Etanercept and must plan to continue using the same form of hormonal contraception for the duration of the study (e.g. until week 18).
Key exclusion criteria (12 listed)
- Use of oral or topical antibiotics, isotretinoin, or intralesional steroids within 30 days prior to day 0 or at any time during the study treatment period.
- Use of systemic immunosuppressants within 90 days prior to day 0 of this study.
- Use of an investigational medication 90 days prior to day 0 of this study.
- Use of a live vaccine 90 days prior to day 0 of this study.
- Any previous use of TNF- α inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etanerceptAlso: Enbreletanercept 50 mg/week subcutaneous injection | Drug | Treatment arm |
Primary outcome
50% Reduction in Physician's Global Assessment Score (Percent of Participants)
Time frame: 12 weeks
Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks. PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease.
4 secondary outcomes
50% Reduction in Number of Lesions (Percent of Participants)
Time frame: 12 weeks
Patient Global Assessment
Time frame: 12 weeks
Patient's Pain Score
Time frame: 12 weeks
Dermatology Life Quality Index Score (DLQI)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19185954Lee RA, Dommasch E, Treat J, Sciacca-Kirby J, Chachkin S, Williams J, Shin DB, Leyden JJ, Vittorio C, Gelfand JM. A prospective clinical trial of open-label etanercept for the treatment of hidradenitis suppurativa. J Am Acad Dermatol. 2009 Apr;60(4):565-73. doi: 10.1016/j.jaad.2008.11.898. Epub 2009 Jan 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Gelfand, MD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing etanercept in people with Hidradenitis Suppurativa, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% Reduction in Physician's Global Assessment Score (Percent of Participants) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00107991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.