Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children
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This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.
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Layout table for eligibility information
Ages Eligible for Study:
4 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion in this study will be as per the approved indications in the package insert.
Patients with moderately to severely active RA.
Children with JRA who have had an inadequate response to one or more DMARDs.
Known hypersensitivity to etanercept or any of its components.
Known significant concurrent medical disease, including:
Congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction
Cancer or history of cancer
Sepsis or risk of sepsis
Active tuberculosis or a past history of tuberculosis
Females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
Patients who are planning to undergo elective surgery during the study period.