Clinical trial NCT01083121: Surveillance of Humira Injection in Korean Patients
Official title: Post-Marketing Surveillance of Humira Injection in Korean Patients Under the "New-Drug Re-examination"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Crohn's Disease
Psoriasis
Keywords: Postmarketing Drug Surveillance
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Eisai Co., Ltd.
First posted: 2010-03-09
Enrollment: 1779
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinics, general hospitals

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From Baseline until up to 70 days after the 3 month study period (total of 160 days).
Secondary outcomes:
measure: Physician's Global Assessment for Effectiveness
timeFrame: After 3-month treatment
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29724
city: Ansan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 53586
city: Bucheon
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29729
city: Bucheon
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29009
city: Busan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29726
city: Busan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29733
city: Busan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 28582
city: Busan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 5633
city: Cheonan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 28608
city: Cheonan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 28996
city: Daegu
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29735
city: Daegu
country: Korea, Republic of
facility: Site Reference ID/Investigator# 59287
city: Daegu
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29278
city: Daegu
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29279
city: Daejeon
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29007
city: Daejeon
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29727
city: Daejeon
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29745
city: Daejeon
country: Korea, Republic of
facility: Site Reference ID/Investigator# 48624
city: Goyang
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29075
city: Guri
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29042
city: Guri
country: Korea, Republic of
facility: Site Reference ID/Investigator# 59285
city: Gwangju
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29731
city: Gwangju
country: Korea, Republic of
facility: Site Reference ID/Investigator# 81693
city: Gwangju
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29732
city: Gwangju
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29737
city: Gwangju
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29742
city: Gyeongju
country: Korea, Republic of
facility: Site Reference ID/Investigator# 28611
city: Iksan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29103
city: Incheon
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29010
city: Jeju
country: Korea, Republic of
facility: Site Reference ID/Investigator# 28589
city: Jeju
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29080
city: Jeollabuk-do
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29743
city: Jeonju
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29082
city: Jinju
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29740
city: Masan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29172
city: Metropolitan city Daejon
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29436
city: Pohang
country: Korea, Republic of
facility: Site Reference ID/Investigator# 28970
city: Seongnam
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29723
city: Seongnam
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29722
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29738
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 53584
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 59283
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29452
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29453
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 53583
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29728
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29734
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29721
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29029
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29736
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 59282
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29741
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29165
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29166
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29011
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 48623
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 63322
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29748
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 53582
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29076
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29034
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29434
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29435
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29744
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29041
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29012
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 66654
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 59284
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29035
city: Seoul
country: Korea, Republic of
facility: Site Reference ID/Investigator# 59286
city: Suwon-si
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29746
city: Suwon
country: Korea, Republic of
facility: Site Reference ID/Investigator# 53588
city: Taegu
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29739
city: Uljeongbu
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29085
city: Ulsan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 28610
city: Ulsan
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29725
city: Wonju
country: Korea, Republic of
facility: Site Reference ID/Investigator# 29730
Study officials:
affiliation: AbbVie Ltd.
name: Deborah Chee, MD
role: STUDY_DIRECTOR
References: