Surveillance of Humira Injection in Korean Patients
|ClinicalTrials.gov Identifier: NCT01083121|
Recruitment Status : Completed
First Posted : March 9, 2010
Results First Posted : August 20, 2013
Last Update Posted : August 21, 2013
|Condition or disease|
|Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Crohn's Disease Psoriasis|
|Study Type :||Observational|
|Actual Enrollment :||1779 participants|
|Official Title:||Post-Marketing Surveillance of Humira Injection in Korean Patients Under the "New-Drug Re-examination"|
|Study Start Date :||April 2007|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
- 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.
- 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'.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083121
Show 77 Study Locations
|Study Director:||Deborah Chee, MD||AbbVie Ltd.|