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Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- Active infection

- Sepsis or risk of sepsis

- Active tuberculosis or a past history of tuberculosis

- Pancytopenia

- 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.

NCT00484809
Pfizer
Completed
Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children

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Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children
A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
Rheumatoid Arthritis
Drug: Enbrel (Etanercept)
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2006
Not Provided

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
    • Active infection
    • Sepsis or risk of sepsis
    • Active tuberculosis or a past history of tuberculosis
    • Pancytopenia
  • 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.
Sexes Eligible for Study: All
4 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00484809
0881A-101511
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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