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Trial record 1 of 1 for:    NCT00195364
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Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain

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: NCT00195364
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : June 4, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 19, 2005
Last Update Posted Date June 4, 2009
Study Start Date July 2003
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
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 Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain
Official Title Long-Term Safety Study of Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain
Brief Summary The purpose of this study is to evaluate long-term safety of etanercept in patients with rheumatoid arthritis who successfully have completed open-label safety study 0881A1-301-EU
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with rheumatoid arthritis who completed trial 0881A1-301-EU in Spain who fulfill inclusion/exclusion criteria, treated in rheumatology units
Condition
  • Rheumatoid Arthritis
  • Inflammation
Intervention Drug: 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: September¬†13,¬†2005)
93
Original Enrollment Same as current
Actual Study Completion Date October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • To have completed 0881A1-301-EU study in Spain
  • Clinical diagnosis by ACR revised criteria of rheumatoid arthritis.

Exclusion Criteria:

  • Hypersensibility to etanercept or any of its components
  • Significant concurrent medical disease
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 Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT00195364
Other Study ID Numbers 0881A1-301, 101492
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
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2009