Surveillance of Humira Injection in Korean Patients

August 20, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1779

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of, 152-703
        • Site Reference ID/Investigator# 29724
      • Ansan, Korea, Republic of, 152-703
        • Site Reference ID/Investigator# 53586
      • Bucheon, Korea, Republic of, 420-767
        • Site Reference ID/Investigator# 29729
      • Bucheon, Korea, Republic of, 420-818
        • Site Reference ID/Investigator# 29009
      • Busan, Korea, Republic of, 602-715
        • Site Reference ID/Investigator# 29726
      • Busan, Korea, Republic of, 602-739
        • Site Reference ID/Investigator# 29733
      • Busan, Korea, Republic of, 608-838
        • Site Reference ID/Investigator# 28582
      • Busan, Korea, Republic of, 611-072
        • Site Reference ID/Investigator# 5633
      • Cheonan, Korea, Republic of, 330-715
        • Site Reference ID/Investigator# 28608
      • Cheonan, Korea, Republic of, 330-721
        • Site Reference ID/Investigator# 28996
      • Daegu, Korea, Republic of, 700-712
        • Site Reference ID/Investigator# 29735
      • Daegu, Korea, Republic of, 705-717
        • Site Reference ID/Investigator# 59287
      • Daegu, Korea, Republic of, 705-718
        • Site Reference ID/Investigator# 29278
      • Daegu, Korea, Republic of, 705-718
        • Site Reference ID/Investigator# 29279
      • Daejeon, Korea, Republic of, 301-808
        • Site Reference ID/Investigator# 29007
      • Daejeon, Korea, Republic of, 302-799
        • Site Reference ID/Investigator# 29727
      • Daejeon, Korea, Republic of, 302-799
        • Site Reference ID/Investigator# 29745
      • Daejeon, Korea, Republic of, 302-799
        • Site Reference ID/Investigator# 48624
      • Goyang, Korea, Republic of, 411-706
        • Site Reference ID/Investigator# 29075
      • Guri, Korea, Republic of, 471-701
        • Site Reference ID/Investigator# 29042
      • Guri, Korea, Republic of, 471-701
        • Site Reference ID/Investigator# 59285
      • Gwangju, Korea, Republic of, 501-717
        • Site Reference ID/Investigator# 29731
      • Gwangju, Korea, Republic of, 501-717
        • Site Reference ID/Investigator# 81693
      • Gwangju, Korea, Republic of, 501-757
        • Site Reference ID/Investigator# 29732
      • Gwangju, Korea, Republic of, 501-757
        • Site Reference ID/Investigator# 29737
      • Gwangju, Korea, Republic of, 501-757
        • Site Reference ID/Investigator# 29742
      • Gyeongju, Korea, Republic of, 780-350
        • Site Reference ID/Investigator# 28611
      • Iksan, Korea, Republic of, 570-711
        • Site Reference ID/Investigator# 29103
      • Incheon, Korea, Republic of, 403-016
        • Site Reference ID/Investigator# 29010
      • Jeju, Korea, Republic of, 690-766
        • Site Reference ID/Investigator# 28589
      • Jeju, Korea, Republic of, 690-767
        • Site Reference ID/Investigator# 29080
      • Jeollabuk-do, Korea, Republic of, 651-180
        • Site Reference ID/Investigator# 29743
      • Jeonju, Korea, Republic of, 560-750
        • Site Reference ID/Investigator# 29082
      • Jinju, Korea, Republic of, 660-702
        • Site Reference ID/Investigator# 29740
      • Masan, Korea, Republic of, 630-522
        • Site Reference ID/Investigator# 29172
      • Metropolitan city Daejon, Korea, Republic of, 302-718
        • Site Reference ID/Investigator# 29436
      • Pohang, Korea, Republic of, 790-825
        • Site Reference ID/Investigator# 28970
      • Seongnam, Korea, Republic of, 463-712
        • Site Reference ID/Investigator# 29723
      • Seongnam, Korea, Republic of, 463-824
        • Site Reference ID/Investigator# 29722
      • Seoul, Korea, Republic of, 110-744
        • Site Reference ID/Investigator# 29738
      • Seoul, Korea, Republic of, 110-744
        • Site Reference ID/Investigator# 53584
      • Seoul, Korea, Republic of, 120-752
        • Site Reference ID/Investigator# 59283
      • Seoul, Korea, Republic of, 130-702
        • Site Reference ID/Investigator# 29452
      • Seoul, Korea, Republic of, 130-702
        • Site Reference ID/Investigator# 29453
      • Seoul, Korea, Republic of, 130-702
        • Site Reference ID/Investigator# 53583
      • Seoul, Korea, Republic of, 133-792
        • Site Reference ID/Investigator# 29728
      • Seoul, Korea, Republic of, 133-792
        • Site Reference ID/Investigator# 29734
      • Seoul, Korea, Republic of, 134-709
        • Site Reference ID/Investigator# 29721
      • Seoul, Korea, Republic of, 134-727
        • Site Reference ID/Investigator# 29029
      • Seoul, Korea, Republic of, 135-710
        • Site Reference ID/Investigator# 29736
      • Seoul, Korea, Republic of, 135-710
        • Site Reference ID/Investigator# 59282
      • Seoul, Korea, Republic of, 135-720
        • Site Reference ID/Investigator# 29741
      • Seoul, Korea, Republic of, 135-895
        • Site Reference ID/Investigator# 29165
      • Seoul, Korea, Republic of, 136-705
        • Site Reference ID/Investigator# 29166
      • Seoul, Korea, Republic of, 137-701
        • Site Reference ID/Investigator# 29011
      • Seoul, Korea, Republic of, 137-701
        • Site Reference ID/Investigator# 48623
      • Seoul, Korea, Republic of, 137-701
        • Site Reference ID/Investigator# 63322
      • Seoul, Korea, Republic of, 138-736
        • Site Reference ID/Investigator# 29748
      • Seoul, Korea, Republic of, 138-736
        • Site Reference ID/Investigator# 53582
      • Seoul, Korea, Republic of, 139-707
        • Site Reference ID/Investigator# 29076
      • Seoul, Korea, Republic of, 139-872
        • Site Reference ID/Investigator# 29034
      • Seoul, Korea, Republic of, 143-729
        • Site Reference ID/Investigator# 29434
      • Seoul, Korea, Republic of, 143-729
        • Site Reference ID/Investigator# 29435
      • Seoul, Korea, Republic of, 150-030
        • Site Reference ID/Investigator# 29744
      • Seoul, Korea, Republic of, 150-071
        • Site Reference ID/Investigator# 29041
      • Seoul, Korea, Republic of, 150-713
        • Site Reference ID/Investigator# 29012
      • Seoul, Korea, Republic of, 156-707
        • Site Reference ID/Investigator# 66654
      • Seoul, Korea, Republic of, 156-755
        • Site Reference ID/Investigator# 59284
      • Seoul, Korea, Republic of, 158-710
        • Site Reference ID/Investigator# 29035
      • Seoul, Korea, Republic of, 366-144
        • Site Reference ID/Investigator# 59286
      • Suwon, Korea, Republic of, 442-723
        • Site Reference ID/Investigator# 53588
      • Suwon-si, Korea, Republic of, 443-721
        • Site Reference ID/Investigator# 29746
      • Taegu, Korea, Republic of
        • Site Reference ID/Investigator# 29739
      • Uljeongbu, Korea, Republic of, 480-824
        • Site Reference ID/Investigator# 29085
      • Ulsan, Korea, Republic of, 681-711
        • Site Reference ID/Investigator# 28610
      • Ulsan, Korea, Republic of, 682-714
        • Site Reference ID/Investigator# 29725
      • Wonju, Korea, Republic of, 220-701
        • Site Reference ID/Investigator# 29730

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinics, general hospitals

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adalimumab
Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: From Baseline until up to 70 days after the 3 month study period (total of 160 days).
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.
From Baseline until up to 70 days after the 3 month study period (total of 160 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician's Global Assessment for Effectiveness
Time Frame: After 3-month treatment
The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'.
After 3-month treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Eisai Co., Ltd.

Investigators

  • Study Director: Deborah Chee, MD, AbbVie Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 20, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P10-053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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