Surveillance of Humira Injection in Korean Patients

Completed

Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Crohn's Disease
Psoriasis

Registration Number: NCT01083121

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1779

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (77): Site Reference ID/Investigator# 66654
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Seoul, Korea, Republic of
Site Reference ID/Investigator# 63322
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Seoul, Korea, Republic of
Site Reference ID/Investigator# 29748
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Seoul, Korea, Republic of
Site Reference ID/Investigator# 29453
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 48623
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29034
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 81693
🇰🇷
Gwangju, Korea, Republic of
Site Reference ID/Investigator# 29742
🇰🇷
Gwangju, Korea, Republic of
Site Reference ID/Investigator# 28611
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Gyeongju, Korea, Republic of
Site Reference ID/Investigator# 59283
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Seoul, Korea, Republic of
Site Reference ID/Investigator# 29434
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29041
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29085
🇰🇷
Uljeongbu, Korea, Republic of
Site Reference ID/Investigator# 53582
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29035
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 59285
🇰🇷
Guri, Korea, Republic of
Site Reference ID/Investigator# 29732
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Gwangju, Korea, Republic of
Site Reference ID/Investigator# 29010
🇰🇷
Incheon, Korea, Republic of
Site Reference ID/Investigator# 29082
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Jeonju, Korea, Republic of
Site Reference ID/Investigator# 29740
🇰🇷
Jinju, Korea, Republic of
Site Reference ID/Investigator# 29722
🇰🇷
Seongnam, Korea, Republic of
Site Reference ID/Investigator# 29738
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 53584
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29452
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29728
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 53583
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 59282
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29741
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29165
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29166
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29076
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29435
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 59284
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 28610
🇰🇷
Ulsan, Korea, Republic of
Site Reference ID/Investigator# 29725
🇰🇷
Ulsan, Korea, Republic of
Site Reference ID/Investigator# 29730
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Wonju, Korea, Republic of
Site Reference ID/Investigator# 53586
🇰🇷
Ansan, Korea, Republic of
Site Reference ID/Investigator# 29724
🇰🇷
Ansan, Korea, Republic of
Site Reference ID/Investigator# 29729
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Bucheon, Korea, Republic of
Site Reference ID/Investigator# 28608
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Cheonan, Korea, Republic of
Site Reference ID/Investigator# 29009
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Bucheon, Korea, Republic of
Site Reference ID/Investigator# 28582
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Busan, Korea, Republic of
Site Reference ID/Investigator# 29733
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Busan, Korea, Republic of
Site Reference ID/Investigator# 5633
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Busan, Korea, Republic of
Site Reference ID/Investigator# 29735
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Daegu, Korea, Republic of
Site Reference ID/Investigator# 28996
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Cheonan, Korea, Republic of
Site Reference ID/Investigator# 59287
🇰🇷
Daegu, Korea, Republic of
Site Reference ID/Investigator# 29007
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Daejeon, Korea, Republic of
Site Reference ID/Investigator# 29278
🇰🇷
Daegu, Korea, Republic of
Site Reference ID/Investigator# 29727
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Daejeon, Korea, Republic of
Site Reference ID/Investigator# 29731
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Gwangju, Korea, Republic of
Site Reference ID/Investigator# 29075
🇰🇷
Goyang, Korea, Republic of
Site Reference ID/Investigator# 48624
🇰🇷
Daejeon, Korea, Republic of
Site Reference ID/Investigator# 29745
🇰🇷
Daejeon, Korea, Republic of
Site Reference ID/Investigator# 29042
🇰🇷
Guri, Korea, Republic of
Site Reference ID/Investigator# 29737
🇰🇷
Gwangju, Korea, Republic of
Site Reference ID/Investigator# 29743
🇰🇷
Jeollabuk-do, Korea, Republic of
Site Reference ID/Investigator# 29103
🇰🇷
Iksan, Korea, Republic of
Site Reference ID/Investigator# 29080
🇰🇷
Jeju, Korea, Republic of
Site Reference ID/Investigator# 28589
🇰🇷
Jeju, Korea, Republic of
Site Reference ID/Investigator# 29436
🇰🇷
Metropolitan city Daejon, Korea, Republic of
Site Reference ID/Investigator# 29723
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Seongnam, Korea, Republic of
Site Reference ID/Investigator# 29739
🇰🇷
Taegu, Korea, Republic of
Site Reference ID/Investigator# 29734
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29736
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29279
🇰🇷
Daegu, Korea, Republic of
Site Reference ID/Investigator# 29029
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29726
🇰🇷
Busan, Korea, Republic of
Site Reference ID/Investigator# 29172
🇰🇷
Masan, Korea, Republic of
Site Reference ID/Investigator# 28970
🇰🇷
Pohang, Korea, Republic of
Site Reference ID/Investigator# 29746
🇰🇷
Suwon-si, Korea, Republic of
Site Reference ID/Investigator# 29721
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Seoul, Korea, Republic of
Site Reference ID/Investigator# 29744
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29011
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 29012
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 59286
🇰🇷
Seoul, Korea, Republic of
Site Reference ID/Investigator# 53588
🇰🇷
Suwon, Korea, Republic of