- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01132235
An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use (ENBRECAP2009)
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33136
- Recruiting
- Florida Academic Dermatology Center
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Contact:
- Annika M Grant, RN.MBA
- Phone Number: 210 305-324-2110
- Email: annikagrant@bellsouth.net
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- ENBRECAP2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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