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

Psoriasis Clinical Trial

— ENBRECAP2009  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01132235
• Other study ID #: ENBRECAP2009
• Status: Recruiting
• Phase: Phase 4
• First received: May 25, 2010
• Last updated: May 27, 2010
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: May 2010
• Source: Florida Academic Dermatology Centers
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• etanercept
50mgs subcutaneous injections twice a week for 12 weeks

Locations

Country	Name	City	State
United States	Florida Academic Dermatology Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida Academic Dermatology Centers	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks	No