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Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Madrid, , 28007 Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis, Inflammation
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

- To have completed 0881A1-301-EU study in Spain

- Clinical diagnosis by ACR revised criteria of rheumatoid arthritis.

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

- Hypersensibility to etanercept or any of its components

- Significant concurrent medical disease

NCT00195364
Pfizer
Completed
Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU 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 Who Completed Trial 0881A1-301-EU in Spain
Official TitleLong-Term Safety Study of Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients with rheumatoid arthritis who completed trial 0881A1-301-EU in Spain who fulfill inclusion/exclusion criteria, treated in rheumatology units
Condition
  • Rheumatoid Arthritis
  • Inflammation
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)
93
Original EnrollmentSame as current
Actual Study Completion DateOctober 2008
Actual Primary Completion DateOctober 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
Ages18 Years and older   (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 NumberNCT00195364
Other Study ID Numbers0881A1-301, 101492
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:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now