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Trial record 1 of 1 for:    NCT00195377
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Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) 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: NCT00195377
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : June 18, 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 18, 2009
Study Start Date April 2003
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00195377 on ClinicalTrials.gov Archive Site
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(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain
Official Title Evaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study
Brief Summary The purpose of this study is to assess the safety of etanercept in patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) or psoriatic arthritis (PsA) in Spain
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with rheumatoid arthritis, psoriatic arthritis or AIJ, treated with etanercept in rheumatology units
Condition
  • Arthritis, Psoriatic
  • Arthritis, Rheumatoid
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)
1000
Original Enrollment Same as current
Actual Study Completion Date April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • RA or PsA in whom DMARDs/antiTNF antibodies/anti IL1 has been insufficient or inappropriate
  • Children from 4 to 17 years old with JIA polyarticular

Exclusion Criteria:

  • Clinically significant abnormal screening lab values
  • Patients who are planning to undergo elective surgery during the study period.
  • Other current autoimmune connective tissue diseases
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years and older   (Child, 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 NCT00195377
Other Study ID Numbers 101393
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