NCT00195377

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

June 18, 2009

Status Verified

June 1, 2009

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

June 17, 2009

Conditions

Arthritis, PsoriaticArthritis, Rheumatoid

Interventions

EtanerceptDRUG

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with rheumatoid arthritis, psoriatic arthritis or AIJ, treated with etanercept in rheumatology units

You may qualify if:

  • 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

You may not qualify if:

  • Clinically significant abnormal screening lab values
  • Patients who are planning to undergo elective surgery during the study period.
  • Other current autoimmune connective tissue diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Madrid, Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Arthritis, PsoriaticArthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesRheumatic DiseasesConnective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

April 1, 2003

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

June 18, 2009

Record last verified: 2009-06

Locations

ES(1)