NCT00484809

Brief Summary

This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2004

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

March 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2007

Completed
Last Updated

December 14, 2007

Status Verified

December 1, 2007

First QC Date

June 8, 2007

Last Update Submit

December 11, 2007

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisjuvenile rheumatoid arthritis

Interventions

Enbrel (Etanercept)DRUG

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderately to severely active RA.
  • Children with JRA who have had an inadequate response to one or more DMARDs.

You may not qualify if:

  • Known hypersensitivity to etanercept or any of its components.
  • Known significant concurrent medical disease, including:
  • Congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction
  • Cancer or history of cancer
  • Active infection
  • Sepsis or risk of sepsis
  • Active tuberculosis or a past history of tuberculosis
  • Pancytopenia
  • Females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
  • Patients who are planning to undergo elective surgery during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis, Juvenile

Interventions

Etanercept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective 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
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 8, 2007

First Posted

June 11, 2007

Study Start

March 1, 2004

Study Completion

February 1, 2006

Last Updated

December 14, 2007

Record last verified: 2007-12