N/A
Completed N=1,014
A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA
Source: ClinicalTrials.gov NCT00195403 ↗Enrolled (actual)
1,014
Serious AEs
0.3%
Results posted
Aug 2013
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 142; 3; 27 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
142; 3; 27 | — |
| PRIMARY Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3 |
7.49; -4.34 | <0.0001 sig |
| SECONDARY Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9 |
17.42; -12.67 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
Rheumatoid Arthritis
- Adults: Treatment of active rheumatoid arthritis (RA) in adults when the response to disease-modifying antirhematic drugs (DMARDs), including MTX, has been inadequate
- Children: Treatment of active polyarticular-course chronic active rheumatoid arthritis in children aged 4 to 17 years who have had an inadequate response to, or whom have proved intolerant of, MTX
Psoriatic Arthritis
- Active and progressive psoriatic arthritis (PsA) in adults who do not respond adequately to previous DMARDs
Exclusion Criteria
- Patients to whom Enbrel is contraindicated as per the local labeling
- Patients with known hypersensitivity to Enbrel 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. (Treatment of Enbrel should not be initiated.)
Data sourced from ClinicalTrials.gov (NCT00195403). 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.