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

NCT00484809

Last updated date
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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.

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Advanced Information
Descriptive Information
Brief Title Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children
Official Title A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Rheumatoid Arthritis
Intervention Drug: Enbrel (Etanercept)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June 8, 2007)
100
Original Enrollment Same as current
Actual Study Completion Date February 2006
Primary Completion Date Not Provided
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00484809
Other Study ID Numbers 0881A-101511
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007