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

Last updated on October 20, 2019

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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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Descriptive Information
Brief TitleStudy Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children
Official TitleA Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).
Brief SummaryThis 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 DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionRheumatoid Arthritis
InterventionDrug: Enbrel (Etanercept)
Study Groups/CohortsNot 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 StatusCompleted
Enrollment
 (submitted: June 8, 2007)
100
Original EnrollmentSame as current
Actual Study Completion DateFebruary 2006
Primary Completion DateNot 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
Ages4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00484809
Other Study ID Numbers0881A-101511
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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