N/A
Completed N=1,779
Surveillance of Humira Injection in Korean Patients
Source: ClinicalTrials.gov NCT01083121 ↗Enrolled (actual)
1,779
Serious AEs
2.8%
Results posted
Aug 2013
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 171; 116; 47; 115 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
171; 116; 47; 115; 58; 7 | — |
| SECONDARY Physician's Global Assessment for Effectiveness |
478; 37; 790; 50; 52; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01083121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.