Trial Outcomes & Findings for Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan) (NCT NCT01230177)
NCT ID: NCT01230177
Last Updated: 2017-02-23
Results Overview
Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor.
COMPLETED
3 participants
12 weeks
2017-02-23
Participant Flow
Participant milestones
| Measure |
Etanercept（Genetial Recombination）
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)
Baseline characteristics by cohort
| Measure |
Etanercept (Renetical Recombination)
n=3 Participants
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
|
|---|---|
|
Age, Customized
<65 years
|
0 participants
n=99 Participants
|
|
Age, Customized
>=65 years
|
3 participants
n=99 Participants
|
|
Gender
Female
|
3 Participants
n=99 Participants
|
|
Gender
Male
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The safety analysis population consisted of the participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor.
Outcome measures
| Measure |
Etanercept（Genetial Recombination）
n=3 Participants
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
|
|---|---|
|
Number of Participants With Treatment Related Adverse Events
|
2 participants
|
PRIMARY outcome
Timeframe: 12 weeksDAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) \<2.6 = remission.
Outcome measures
| Measure |
Etanercept（Genetial Recombination）
n=1 Participants
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
|
|---|---|
|
Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
At 0 week
|
3.55 Score
Standard Deviation 0
|
|
Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
At 8 weeks
|
2.72 Score
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 12 weeksDAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) \<2.6 = remission.
Outcome measures
| Measure |
Etanercept（Genetial Recombination）
n=1 Participants
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
|
|---|---|
|
Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
At 0 week
|
0 percent change
Standard Deviation 0
|
|
Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
At 8 weeks
|
-23.58 percent change
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).
On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: "effective" or "ineffective". To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation.
Outcome measures
| Measure |
Etanercept（Genetial Recombination）
n=3 Participants
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
|
|---|---|
|
Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values
Effective
|
3 participants
|
|
Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values
Ineffective
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).
On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: "effective" or "ineffective". To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation.
Outcome measures
| Measure |
Etanercept（Genetial Recombination）
n=3 Participants
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
|
|---|---|
|
Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values
Effective
|
3 participants
|
|
Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values
Ineffective
|
0 participants
|
Adverse Events
Etanercept（Genetial Recombination）
Serious adverse events
| Measure |
Etanercept（Genetial Recombination）
n=3 participants at risk
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
|
|---|---|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1
The frequency of treatment related adverse events during the study
|
Other adverse events
| Measure |
Etanercept（Genetial Recombination）
n=3 participants at risk
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
66.7%
2/3 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Eye disorders
Keratitis
|
33.3%
1/3 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
General disorders
Injection site reaction
|
33.3%
1/3 • Number of events 1
The frequency of treatment related adverse events during the study
|
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