Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

NCT00245934

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1-800-718-1021

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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
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

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Advanced Information
Descriptive Information
Brief Title Study Evaluating Enbrel in Patients With Rheumatoid Arthritis
Official Title Observational Study With Enbrel in Patients With Rheumatoid Arthritis
Brief Summary The 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 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
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: October 26, 2005)
1500
Original Enrollment Same as current
Actual Study Completion Date July 2005
Primary Completion Date Not 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
Ages 18 Years and older   (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 NCT00245934
Other Study ID Numbers 101354
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
Principal Investigator:Trial ManagerFor Germany, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007