N/A
N=113
Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]
Juvenile Idiopathic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01145352 ↗Enrolled (actual)
113
Serious AEs
1.0%
Results posted
Sep 2014
Primary outcome: Primary: Number of Participants With Treatment-Related Adverse Events of Etanercept — 22 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Etanercept (genetical recombination) (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events of Etanercept |
22 | — |
| PRIMARY Number of Participants With Serious Treatment-Related Adverse Events of Etanercept |
1 | — |
| PRIMARY Number of Unlisted Treatment-Related Adverse Events of Etanercept |
3 | — |
| PRIMARY Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 |
72.00; 73.33; 70.97; 75.00; 73.53; 63.04 | — |
| SECONDARY Percentage of Participants With Overall Improvement On Physician's Assessment. |
94.12; 93.65; 93.75; 93.85; 91.04; 95.18 | — |
Summary
This surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated ENBREL as a treatment for active polyarticular JIA.
1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious adverse events
2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.
Eligibility Criteria
Inclusion Criteria
- Patients in active polyarticular JIA (restricted to the case of lack of effect by other treatment) during enrollment period (2.5years).
- Patients receiving Enbrel for JIA as diagnosed by a qualified physician.
- Age 5 - 16 years
Exclusion Criteria
- Patients not administered ENBREL
Data sourced from ClinicalTrials.gov (NCT01145352). 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.