NCT00195416

Brief Summary

To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulations.

  1. 1.Unknown adverse reactions, especially serious adverse reactions
  2. 2.Change of the incidences of adverse reactions under the routine drug uses
  3. 3.Factors that may affect the safety of the drug
  4. 4.Factors that may affect the effectiveness of the drug

Trial Health

87
On Track

Trial Health Score

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

Enrollment
526

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 16, 2009

Status Verified

September 1, 2009

Enrollment Period

3.2 years

First QC Date

September 12, 2005

Last Update Submit

September 15, 2009

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis

Interventions

EtanerceptDRUG

Etanercept 25mg Injection, 2 times/week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic, secondary and tertiary medical centers

You may qualify if:

  • Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy

You may not qualify if:

  • Patients with known hypersensitivity to Enbrel or any component of the product
  • Patients with sepsis or risk of sepsis
  • Patients with active infections including chronic or localized infections such as tuberculosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Gyunggi-do, 463-707, South Korea

Location

Unknown Facility

Seoul, 140-575, South Korea

Location

Unknown Facility

Seoul, 143-914, South Korea

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

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
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

June 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 16, 2009

Record last verified: 2009-09

Locations

KR(3)