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Trial record 1 of 1 for:    NCT00245934
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Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00245934
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : December 14, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date October 26, 2005
First Posted Date October 28, 2005
Last Update Posted Date December 14, 2007
Study Start Date June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, MedinfoDEU@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007