At a glance
ClinicalIndex Comparison Record- ✓Adults with active RA and inadequate response to DMARDs including methotrexate
- ✓Children aged 4-17 years with polyarticular-course chronic active RA with inadequate response to or intolerance of methotrexate
- ✓Adults with active and progressive psoriatic arthritis unresponsive to previous DMARDs
- ✕Patients with known hypersensitivity to Etanercept or any component of the product
- ✕Patients with sepsis or risk of sepsis
- ✕Patients with active infections including chronic or localized infections such as tuberculosis
- ✕Patients to whom Enbrel is contraindicated per local labeling
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Drug Use Investigation of Enbrel for Post-Marketing Surveillance
In Brief
An observational study evaluating Etanercept for Rheumatoid Arthritis. Completed, enrolled 1,014 participants across 4 sites.
Detailed Summary
The objective of this investigation is to identify the following problems and questions with respect to the safety and efficacy of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulation. 1. Unknown adverse reactions, especially serious adverse reactions 2. Incidences of adverse reactions under routine drug uses 3. Factors that may affect the safety of the drug 4. Factors that may affect the efficacy of the drug This investigation spanned 3 different studies, 0881A-101575 (alias B1801105) NCT00195403, 0881A-102018 (alias B1801112) NCT00195416 and 0881A-102212 (alias B1801113). All studies have been combined into this record.
Study Details
Timeline
Interventions
Etanercept 25mg Injection, 2 times/week