An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use

NCT ID: NCT01132235

Last Updated: 2010-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-12-31

Brief 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.

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

etanercept

50mgs subcutaneous injections twice a week for 12 weeks

Intervention Type: BIOLOGICAL

Eligibility Criteria

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%

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Florida Academic Dermatology Centers

OTHER

Sponsor Role: lead

Responsible Party

Florida Academic Dermatology Centers

Locations

Florida Academic Dermatology Center

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Annika M Grant, RN.MBA

Role: primary

Other Identifiers

ENBRECAP2009

Identifier Type: -

Identifier Source: org_study_id