PsoriasisPhase 4ENBRECAP2009NCT01132235
An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use
A Phase 4 study testing etanercept in people with Psoriasis, run by Florida Academic Dermatology Centers at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg subcutaneous injections twice weekly for 12 weeks in subjects who have previously been treated etanercept and efficacy diminished. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- etanercept
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 with psoriasis who have previously been treated with etanercept for a minimum of 6 months and discontinued treatment due to loss of efficacy. Every attempt will be made to obtain loss of efficacy history from the subject's medical chart;when etanercept was commenced and terminated and description of patient's psoriasis on termination and details of new treatment commenced. Subjects must have failed their latest psoriasis treatment after a period of three months. This will be measured as a PGA of ≥ 3.
- There is no specific requirement as to when prior treatment with etanercept occurred and no requirement as to what type of treatment(s) used between initial and subsequent treatments.
- Are ≥ 18 years of age
- PGA ≥ 3
- BSA minimum of 5%
- Tuberculosis inclusion criteria
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- Have no history of latent or active TB prior to screening.
- Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
- Have had no recent close contact with a person with active TB.
- Within 1 month prior to the first administration of study have a negative tuberculin skin test.
- The ability to give written informed consent and comply with study procedures.
Who cannot join
- Current enrollment in any other investigational device or investigational drug trial(s), or receipt of any other investigational agent(s) within 28 days before baseline visit.
- Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.
- Latex sensitivity [NB: only applicable if they are using prefilled syringe or prefilled SureClick™ autoinjector presentations]
- Prior or concurrent use of cyclophosphamide therapy
- Concurrent sulfasalazine therapy.
- A positive HBV test or known history of any other immuno-suppressing disease.
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- Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family member with TB, positive purified protein derivative (PPD) or taking anti-tuberculosis medication.
- Active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits.
- History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection and Hepatitis C, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB, or other opportunistic infections
- If etanercept was previously discontinued due to a serious adverse event
- Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity; or myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 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 of the skin or in situ cervical cancer])
- Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder.
- Use of a live vaccine 90 days prior to screening visit, or concurrent use of a live vaccine.
- Any condition or circumstances judged by the patient's physician [or the investigator or medically qualified study staff] to render this clinical trial detrimental or otherwise unsuitable for the patient's participation.
- Female subjects who are pregnant, nursing or planning pregnancy (both men and women) and not using acceptable methods of birth control during the trial (hormonal, barriers, abstinence).
- Women who are breast feeding
- History of non-compliance with other therapies.
- History of alcohol abuse within the last 12 months
- Concurrent use of anakinra
- Subjects who cannot discontinue any of the drugs below for 2 weeks prior to the baseline visit or during the study;
- A two week wash out period is appropriate as it would be unethical to expect subjects whose disease if flaring to remain untreated for a longer period of time. The first dose of etanercept will be administered two weeks after the last biologic dose.
- Immunosuppressants, antimalarials, or sulfasalazine.
- Other Ani-TNFs
- Cyclosporine
- Efalizumab
- Azathioprine
- Hydroxyurea
- Live vaccines
- Tacrolimus
- Oral retinoids (isotretinoin,acitretin,bexarotene)
- Ultra violet light therapies
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Florida Academic Dermatology Center
Miami, Florida, 33136
Annika M Grant, RN.MBA, 305-324-2110 ext. 210, annikagrant@bellsouth.net
About this study
The purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg subcutaneous injections twice weekly for 12 weeks in subjects who have previously been treated etanercept and efficacy diminished.
- Conditions
- Psoriasis
- Being tested
- etanercept
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptBiological
50mgs subcutaneous injections twice a week for 12 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients achieving a Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12.
Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12 will measure efficacy of retreatment with etanercept
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 posted27 May 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Academic Dermatology Centers
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132235
- Sponsor's protocol ID
- ENBRECAP2009
- Acronym
- ENBRECAP2009
- Status last verified
- May 2010
- First submitted
- 25 May 2010
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use
- ClinicalTrials.gov ID
- NCT01132235
- Acronym / sponsor ID
- ENBRECAP2009 / ENBRECAP2009
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Florida Academic Dermatology CentersUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 27 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg subcutaneous injections twice weekly for 12 weeks in subjects who have previously been treated etanercept and efficacy diminished.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects with psoriasis who have previously been treated with etanercept for a minimum of 6 months and discontinued treatment due to loss of efficacy. Every attempt will be made to obtain loss of efficacy history from the subject's medical chart;when etanercept was commenced and terminated and description of patient's psoriasis on termination and details of new treatment commenced. Subjects must have failed their latest psoriasis treatment after a period of three months. This will be measured as a PGA of ≥ 3.
- There is no specific requirement as to when prior treatment with etanercept occurred and no requirement as to what type of treatment(s) used between initial and subsequent treatments.
- Are ≥ 18 years of age
- PGA ≥ 3
- BSA minimum of 5%
Key exclusion criteria (31 listed)
- Current enrollment in any other investigational device or investigational drug trial(s), or receipt of any other investigational agent(s) within 28 days before baseline visit.
- Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.
- Latex sensitivity [NB: only applicable if they are using prefilled syringe or prefilled SureClick™ autoinjector presentations]
- Prior or concurrent use of cyclophosphamide therapy
- Concurrent sulfasalazine therapy.
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 |
|---|---|---|
| etanercept50mgs subcutaneous injections twice a week for 12 weeks | Biological | – |
Primary outcome
The proportion of patients achieving a Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12.
Time frame: 12 weeks
Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12 will measure efficacy of retreatment with etanercept
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
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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.
Florida Academic Dermatology Center
Miami, United States
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, run by Florida Academic Dermatology Centers 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 11 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 28 May 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients achieving a Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12. (time frame: 12 weeks). 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 28 May 2010.