Surveillance of Humira Injection in Korean Patients
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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Post-Marketing Surveillance of Humira Injection in Korean Patients Under the "New-Drug Re-examination"|
- 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). ] [ Designated as safety issue: Yes ]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.
- Physician's Global Assessment for Effectiveness [ Time Frame: After 3-month treatment ] [ Designated as safety issue: No ]The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'.
|Study Start Date:||April 2007|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083121
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|Study Director:||Deborah Chee, MD||AbbVie Ltd.|