PsoriasisPhase 4NCT01053819
Can We Miss Pigmented Lesions in Psoriasis Patients?
A Phase 4 study testing etanercept in people with Psoriasis and Melanoma, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
In psoriasis patients, thick psoriatic plaques can obscure these lesions, and clinicians rely heavily on visual inspection to recognize suspicious or atypical pigmented lesions. However, successful systemic treatment and subsequent clearing of psoriatic plaques may allow clinicians to better evaluate pigmented… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Melanoma, Non-melanoma Skin Cancer
- What is being tested?
- etanercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Apr 2012
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of moderate to severe plaque psoriasis identified by a BSA greater than or equal to 10% and a Psoriasis Area and Severity Index score greater than or equal to 12
- Age 19 years or above
- Fitzpatrick skin type I, II or III
- Candidate for systemic treatment in the opinion of the investigator
- Willingness to undergo treatment with Enbrel as outlined above
- Negative pregnancy test (urine or serum β-Human Chorionic Gonadotrophin ) before the first dose of study drug in all women (except those surgically sterile, or at least 5 years postmenopausal).
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- Negative Tuberculosis skin test at entry into the study or a negative screening x-ray in inconclusive Purified Protein Derivative reading (borderline, reactive but non-diagnostic) or in prior bacille Calmette-Guerin inoculated subjects.
- Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study
- Subject or designee must have the ability to self-inject study medication or have a care giver at home who can administer subcutaneous injections
- Must be able and willing to give written informed consent and comply with the requirements of the study protocol and must authorize release and use of protected health information
Who cannot join
- Serum creatinine > 3.0 mg/dL (265 micromoles/L)
- Serum potassium < 3.5 mmol/L or > 5.5 mmol/L
- Serum alanine aminotransferase or Aspartate transaminase > 3 times the upper limit of normal for the Lab
- Platelet count < 100,000/mm3
- White blood cell count < 3,000 cells/mm3
- Hemoglobin, hematocrit, or red blood cell count outside 30% of the upper or lower limits of normal for the Lab
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- Systemic therapy use (e.g. phototherapy, methotrexate, cyclosporine, oral steroids, systemic biologics) within the previous 4 weeks
- Topical therapy use (e.g. topical steroids, vitamin D derivatives) within the previous 2 weeks
- Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
- Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept
- Prior or concurrent cyclophosphamide therapy
- Concurrent sulfasalazine therapy
- Known Human immunodeficiency virus-positive status or known history of any other immunosuppressing disease
- Active severe infections within 4 weeks before screening visit, or between the screening and baseline visits
- Untreated Lyme disease
- Severe comorbidities (diabetes mellitus requiring insulin, CHF of any severity, MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg), oxygen-dependent severe pulmonary disease, history of cancer within 5 years [other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer])
- History of TB or TB exposure, chronic hepatitis B or hepatitis C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy
- History of recent alcohol or substance abuse (< 1 year)
- Pregnant or lactating females
- Use of a live vaccine 90 days prior to, or during this study
- Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient
- History of non-compliance with other therapies
Trial locations and contacts
1 site in 1 country.
About this study
In psoriasis patients, thick psoriatic plaques can obscure these lesions, and clinicians rely heavily on visual inspection to recognize suspicious or atypical pigmented lesions. However, successful systemic treatment and subsequent clearing of psoriatic plaques may allow clinicians to better evaluate pigmented lesions, thereby increasing the likelihood of early identification and treatment of suspicious lesions such as nonmelanoma skin cancer and malignant melanoma.
Read the detailed description
No further description is desired.
- Conditions
- Psoriasis, Melanoma, Non-melanoma Skin Cancer
- Being tested
- etanercept
- Keywords
- psoriasis, melanoma, non-melanoma skin cancer, etanercept, Enbrel
- Medical subject headings
- Psoriasis, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
Also called Enbrel
Patients will receive six months of treatment with Enbrel 50mg SQ given twice a week for the first three months and 50 mg once a week thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | open label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks Receives: Drug: etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint for This Study Will be a Change From Baseline in the Number of Pigmented Lesions on Skin Previously Covered by Psoriatic Plaques.
Measured: Patients will complete study within 6 months.
Secondary outcomes (1)
A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria
The data for this Outcome was not collected and due to the length of time, the records have been destroyed.
Measured: Patients will complete the study within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startSep 2007
- Primary completionApr 2012
- Study completionApr 2012
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.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Boni Elewski, MD, University of Alabama at Birmingham
- Investigators
- Boni E Elewski, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053819
- Sponsor's protocol ID
- F070629011
- Status last verified
- Jan 2018
- First submitted
- 6 Feb 2009
- Last updated
- 23 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can We Miss Pigmented Lesions in Psoriasis Patients?
- ClinicalTrials.gov ID
- NCT01053819
- Acronym / sponsor ID
- F070629011
- Conditions
- Psoriasis, Melanoma, Non-melanoma Skin Cancer
- Keywords
- psoriasis, melanoma, non-melanoma skin cancer, etanercept, Enbrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Sep 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Posted 22 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In psoriasis patients, thick psoriatic plaques can obscure these lesions, and clinicians rely heavily on visual inspection to recognize suspicious or atypical pigmented lesions. However, successful systemic treatment and subsequent clearing of psoriatic plaques may allow clinicians to better evaluate pigmented lesions, thereby increasing the likelihood of early identification and treatment of suspicious lesions such as nonmelanoma skin cancer and malignant melanoma.
Detailed description
No further description is desired.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: etanerceptopen label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of moderate to severe plaque psoriasis identified by a BSA greater than or equal to 10% and a Psoriasis Area and Severity Index score greater than or equal to 12
- Age 19 years or above
- Fitzpatrick skin type I, II or III
- Candidate for systemic treatment in the opinion of the investigator
- Willingness to undergo treatment with Enbrel as outlined above
Key exclusion criteria (22 listed)
- Serum creatinine > 3.0 mg/dL (265 micromoles/L)
- Serum potassium < 3.5 mmol/L or > 5.5 mmol/L
- Serum alanine aminotransferase or Aspartate transaminase > 3 times the upper limit of normal for the Lab
- Platelet count < 100,000/mm3
- White blood cell count < 3,000 cells/mm3
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: EnbrelPatients will receive six months of treatment with Enbrel 50mg SQ given twice a week for the first three months and 50 mg once a week thereafter. | Drug | Etanercept |
Primary outcome
The Primary Endpoint for This Study Will be a Change From Baseline in the Number of Pigmented Lesions on Skin Previously Covered by Psoriatic Plaques.
Time frame: Patients will complete study within 6 months.
1 secondary outcome
A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria
Time frame: Patients will complete the study within 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Boni E Elewski, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etanercept in people with Psoriasis and Melanoma, run by University of Alabama at Birmingham at 1 site in United States.
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 10 inclusion and 22 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 22 Aug 2012). 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?
The Primary Endpoint for This Study Will be a Change From Baseline in the Number of Pigmented Lesions on Skin Previously Covered by Psoriatic Plaques. (time frame: Patients will complete study within 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2018.