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

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

What this study is about