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COMPLETED

Surveillance of Humira Injection in Korean Patients

Post-Marketing Surveillance of Humira Injection in Korean Patients Under the "New-Drug Re-examination"

NCT01083121•AbbVie (prior sponsor, Abbott)

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult patients (19 years and above) with one of the following indications:
•* Moderately to severely active rheumatoid arthritis or
•* active and progressive psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate or
•* severe active ankylosing spondylitis who have had an inadequate response to conventional therapy or
•* severely active Crohn's disease who have had no response, intolerance or contraindication to corticosteroid therapy or immunosuppressants or
•* moderately to severely active psoriasis patients who have had no response, have intolerance or have contraindication to systemic therapies including cyclosporine, methotrexate or photochemotherapy (PUVA).
•Patients who give verbal or written authorization to use their personal and health data.

Exclusion Criteria

•\- Patients with known hypersensitivity to adalimumab or any of its excipients.

Locations (77)

Site Reference ID/Investigator# 29724

Ansan, South Korea

Site Reference ID/Investigator# 53586

Ansan, South Korea

Site Reference ID/Investigator# 29729

Bucheon-si, South Korea

Site Reference ID/Investigator# 29009

Bucheon-si, South Korea

Site Reference ID/Investigator# 29726

Busan, South Korea

Site Reference ID/Investigator# 29733

Busan, South Korea

Site Reference ID/Investigator# 28582

Busan, South Korea

Site Reference ID/Investigator# 5633

Busan, South Korea

Site Reference ID/Investigator# 28608

Cheonan, South Korea

Site Reference ID/Investigator# 28996

Cheonan, South Korea

Key Dates

Start Date

April 1, 2007

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2012

Last Updated

August 21, 2013

Enrollment

1,779

ACTUAL participants

Conditions

Rheumatoid ArthritisPsoriatic ArthritisAnkylosing SpondylitisCrohn's DiseasePsoriasis

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RECRUITING

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Surveillance of Humira Injection in Korean Patients

Inclusion Criteria

Exclusion Criteria

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