Surveillance of Humira Injection in Korean Patients

NCT01083121 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1779

Last updated 2013-08-21

Study results available
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Summary

Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of Humira. Information on demographics, diagnosis and medical history, results of tuberculosis skin test, results of chest X-ray, Humira treatment information, concomitant medication, physician's global assessment for effectiveness, disease activity assessment for rheumatoid arthritis, disease activity assessment for Crohn's Disease, disease activity assessment for Psoriasis and adverse events will be recorded on case report forms.

Conditions

Sponsors & Collaborators

  • Eisai Co., Ltd.

    collaborator INDUSTRY
  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Deborah Chee, MD · AbbVie Ltd.

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01083121 on ClinicalTrials.gov