Arthritis, Psoriatic
Conditions
Keywords
Arthritis, psoriatic
Brief summary
The purpose of this study is to collect post-marketing information on the safety of Enbrel in Filipino patients.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients from the study center who received or will receive at least one dose of Enbrel according to the approved product indication.
Exclusion criteria
* Previously discontinued Enbrel therapy due to significant safety concern.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection | 30 days post injection up to 3 years |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Etanercept (Enbrel) 25 mg by subcutaneous injection | 93 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age Continuous | 41.8 years STANDARD_DEVIATION 18.7 |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 93 |
| serious Total, serious adverse events | 1 / 93 |
Outcome results
Primary
Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection
Time frame: 30 days post injection up to 3 years
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection | 7 Participants |