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Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain

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NCT00195377

Last updated on November 9, 2019
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FOR MORE INFORMATION
Study Location
Madrid, , 28007 Spain
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic Arthritis, Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- Clinically significant abnormal screening lab values

- Patients who are planning to undergo elective surgery during the study period.

- Other current autoimmune connective tissue diseases

NCT00195377
Pfizer
Completed
Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief TitleStudy Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain
Official TitleEvaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients with rheumatoid arthritis, psoriatic arthritis or AIJ, treated with etanercept in rheumatology units
Condition
  • Arthritis, Psoriatic
  • Arthritis, Rheumatoid
InterventionDrug: Etanercept
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: September 13, 2005)		1000
Original EnrollmentSame as current
Actual Study Completion DateApril 2006
Actual Primary Completion DateApril 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
Ages4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesSpain
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00195377
Other Study ID Numbers101393
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
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJune 2009

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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