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Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

Last updated on November 19, 2019

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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Proven diagnosis of rheumatoid arthritis

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

- Contraindications according to Summary of Product Characteristic (SmPC)of Enbrel® the
following points will prevent or restrict participation:

- Patients who suffer from hypersensitivity to the active substance Etanercept or
to any of the excipients of Enbrel®

- Treatment with Enbrel® should not be initiated in patients with active infections
including chronic or localized infections

- Patients with sepsis or risk of sepsis should not be treated

NCT00245934
Pfizer
Completed
Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Descriptive Information
Brief TitleStudy Evaluating Enbrel in Patients With Rheumatoid Arthritis
Official TitleObservational Study With Enbrel in Patients With Rheumatoid Arthritis
Brief SummaryThe purpose of this study is to investigate the incidence of adverse events for patients with rheumatoid arthritis treated with Enbrel under usual care settings. In addition, differences in injection site reactions based on whether health care professionals or patients administer Enbrel will be assessed and evaluated.
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
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: October 26, 2005)
1500
Original EnrollmentSame as current
Actual Study Completion DateJuly 2005
Primary Completion DateNot Provided
Eligibility Criteria

Inclusion Criteria:

  • Proven diagnosis of rheumatoid arthritis

Exclusion Criteria:

  • Contraindications according to Summary of Product Characteristic (SmPC)of Enbrel® the following points will prevent or restrict participation:

    • Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®
    • Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localized infections
    • Patients with sepsis or risk of sepsis should not be treated
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (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 NumberNCT00245934
Other Study ID Numbers101354
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
Principal Investigator:Trial ManagerFor Germany, [email protected]
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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