NCT00683384

Brief Summary

The purpose of this study is to collect post-marketing information on the safety of Enbrel in Filipino patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 16, 2010

Completed
Last Updated

November 16, 2010

Status Verified

October 1, 2010

Enrollment Period

2.8 years

First QC Date

May 21, 2008

Results QC Date

October 15, 2010

Last Update Submit

October 15, 2010

Conditions

Arthritis, Psoriatic

Keywords

Arthritispsoriatic

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection

    30 days post injection up to 3 years

Study Arms (1)

1

Drug: Etanercept (Enbrel)

Interventions

Etanercept (Enbrel)DRUG
1

Eligibility Criteria

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

Primary Care

You may qualify if:

  • All patients from the study center who received or will receive at least one dose of Enbrel according to the approved product indication.

You may not qualify if:

  • Previously discontinued Enbrel therapy due to significant safety concern.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Metro Manila, Philippines

Location

MeSH Terms

Conditions

Arthritis, PsoriaticArthritis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue 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

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 23, 2008

Study Start

January 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 16, 2010

Results First Posted

November 16, 2010

Record last verified: 2010-10

Locations

PH(1)