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Surveillance of Humira Injection in Korean Patients

NCT ID: NCT01083121

Last Updated: 2013-08-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1779 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Crohn's Disease Psoriasis

Keywords

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Postmarketing Drug Surveillance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Adalimumab

Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah Chee, MD

Role: STUDY_DIRECTOR

AbbVie Ltd.

Locations

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Site Reference ID/Investigator# 29724

Ansan, , South Korea

Site Status

Site Reference ID/Investigator# 53586

Ansan, , South Korea

Site Status

Site Reference ID/Investigator# 29729

Bucheon-si, , South Korea

Site Status

Site Reference ID/Investigator# 29009

Bucheon-si, , South Korea

Site Status

Site Reference ID/Investigator# 29726

Busan, , South Korea

Site Status

Site Reference ID/Investigator# 29733

Busan, , South Korea

Site Status

Site Reference ID/Investigator# 28582

Busan, , South Korea

Site Status

Site Reference ID/Investigator# 5633

Busan, , South Korea

Site Status

Site Reference ID/Investigator# 28608

Cheonan, , South Korea

Site Status

Site Reference ID/Investigator# 28996

Cheonan, , South Korea

Site Status

Site Reference ID/Investigator# 29735

Daegu, , South Korea

Site Status

Site Reference ID/Investigator# 59287

Daegu, , South Korea

Site Status

Site Reference ID/Investigator# 29278

Daegu, , South Korea

Site Status

Site Reference ID/Investigator# 29279

Daegu, , South Korea

Site Status

Site Reference ID/Investigator# 29007

Daejeon, , South Korea

Site Status

Site Reference ID/Investigator# 29727

Daejeon, , South Korea

Site Status

Site Reference ID/Investigator# 29745

Daejeon, , South Korea

Site Status

Site Reference ID/Investigator# 48624

Daejeon, , South Korea

Site Status

Site Reference ID/Investigator# 29075

Goyang, , South Korea

Site Status

Site Reference ID/Investigator# 29042

Guri-si, , South Korea

Site Status

Site Reference ID/Investigator# 59285

Guri-si, , South Korea

Site Status

Site Reference ID/Investigator# 29731

Gwangju, , South Korea

Site Status

Site Reference ID/Investigator# 81693

Gwangju, , South Korea

Site Status

Site Reference ID/Investigator# 29732

Gwangju, , South Korea

Site Status

Site Reference ID/Investigator# 29737

Gwangju, , South Korea

Site Status

Site Reference ID/Investigator# 29742

Gwangju, , South Korea

Site Status

Site Reference ID/Investigator# 28611

Gyeongju, , South Korea

Site Status

Site Reference ID/Investigator# 29103

Iksan, , South Korea

Site Status

Site Reference ID/Investigator# 29010

Incheon, , South Korea

Site Status

Site Reference ID/Investigator# 28589

Jeju City, , South Korea

Site Status

Site Reference ID/Investigator# 29080

Jeju City, , South Korea

Site Status

Site Reference ID/Investigator# 29743

Jeollabuk-do, , South Korea

Site Status

Site Reference ID/Investigator# 29082

Jeonju, , South Korea

Site Status

Site Reference ID/Investigator# 29740

Jinju, , South Korea

Site Status

Site Reference ID/Investigator# 29172

Masan, , South Korea

Site Status

Site Reference ID/Investigator# 29436

Metropolitan City Daejon, , South Korea

Site Status

Site Reference ID/Investigator# 28970

Pohang, , South Korea

Site Status

Site Reference ID/Investigator# 29723

Seongnam, , South Korea

Site Status

Site Reference ID/Investigator# 29722

Seongnam, , South Korea

Site Status

Site Reference ID/Investigator# 29738

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 53584

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 59283

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29452

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29453

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 53583

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29728

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29734

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29721

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29029

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29736

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 59282

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29741

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29165

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29166

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29011

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 48623

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 63322

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29748

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 53582

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29076

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29034

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29434

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29435

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29744

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29041

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29012

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 66654

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 59284

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 29035

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 59286

Seoul, , South Korea

Site Status

Site Reference ID/Investigator# 53588

Suwon, , South Korea

Site Status

Site Reference ID/Investigator# 29746

Suwon, , South Korea

Site Status

Site Reference ID/Investigator# 29739

Taegu, , South Korea

Site Status

Site Reference ID/Investigator# 29085

Uljeongbu, , South Korea

Site Status

Site Reference ID/Investigator# 28610

Ulsan, , South Korea

Site Status

Site Reference ID/Investigator# 29725

Ulsan, , South Korea

Site Status

Site Reference ID/Investigator# 29730

Wŏnju, , South Korea

Site Status

Countries

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South Korea

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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P10-053

Identifier Type: -

Identifier Source: org_study_id