View Clinical Trial (Medical Research Study)
An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use
| City: |
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Miami |
| State: |
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Florida |
| Zip Code: |
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33136 |
| Conditions: |
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Psoriasis |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01132235 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Miami, Florida 33136
United States
Annika M Grant, RN.MBA
Phone: 305-324-2110
Email: annikagrant@bellsouth.net
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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