Trial Outcomes & Findings for Study Evaluating the Safety of Enbrel (Etanercept) (NCT NCT00683384)
NCT ID: NCT00683384
Last Updated: 2010-11-16
Results Overview
Recruitment status
COMPLETED
Target enrollment
93 participants
Primary outcome timeframe
30 days post injection up to 3 years
Results posted on
2010-11-16
Participant Flow
Participant milestones
| Measure |
Etanercept
Etanercept (Enbrel) 25 mg by subcutaneous injection
|
|---|---|
|
Overall Study
STARTED
|
93
|
|
Overall Study
COMPLETED
|
91
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Etanercept
Etanercept (Enbrel) 25 mg by subcutaneous injection
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Study Evaluating the Safety of Enbrel (Etanercept)
Baseline characteristics by cohort
| Measure |
Etanercept
n=93 Participants
Etanercept (Enbrel) 25 mg by subcutaneous injection
|
|---|---|
|
Age Continuous
|
41.8 years
STANDARD_DEVIATION 18.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post injection up to 3 yearsPopulation: Full analysis set
Outcome measures
| Measure |
Etanercept
n=93 Participants
Etanercept (Enbrel) 25 mg by subcutaneous injection
|
|---|---|
|
Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection
|
7 Participants
|
Adverse Events
Etanercept
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept
n=93 participants at risk
Etanercept (Enbrel) 25 mg by subcutaneous injection
|
|---|---|
|
General disorders
Death
|
1.1%
1/93
|
Other adverse events
| Measure |
Etanercept
n=93 participants at risk
Etanercept (Enbrel) 25 mg by subcutaneous injection
|
|---|---|
|
General disorders
Hyperhidrosis
|
1.1%
1/93
|
|
General disorders
Injection site irritation
|
1.1%
1/93
|
|
General disorders
Injection site pruritus
|
1.1%
1/93
|
|
Investigations
Transaminases increased
|
1.1%
1/93
|
|
Nervous system disorders
Formication
|
1.1%
1/93
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.1%
1/93
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER