Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)

Arthritis Clinical Trial

Official title:

Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230177
• Other study ID #: B1801134
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2010
• Last updated: November 5, 2013
• Start date: May 2011
• Est. completion date: April 2013

Study information

• Verified date: November 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This survey is conducted to investigate safety and efficacy under the post marketed drug utilization on the patient with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) at the time of switching regimen from 10 mg twice a week administration to 25 mg once a week administration.

Description:

Implemented as a Special Investigation by Central Registration System

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients need to be administered etanercept in order to be enrolled in the survey

• Patients who have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

Exclusion Criteria:

• Patients who have been administered etanercept 50mg once a week

• Patients who have been administered etanercept 25mg once a week

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Rheumatoid

Intervention

Drug:
• etanercept (genetical recombination)
10 to 25 mg of etanercept (genetical recombination) reconstituted in 1 mL of water for injection (JP) administered twice weekly as a subcutaneous injection or 25 to 50 mg of etanercept (genetical recombination) administered once weekly as a subcutaneous injection, are usually the recommended dose for adults.

Locations

Country	Name	City	State
Japan	Taihaku Sakura Hospital	Sendai	Miyagi

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events		12 weeks	Yes
Primary	Adverse events not expected from Japanese Package Insert (unknown adverse events)		12 weeks	Yes
Primary	Score of DAS28-4ER (amount of change)		12 weeks	No
Secondary	overall improvement scale (assessed by physician)		12 weeks	No

External Links

•   To obtain contact information for a study center near you, click here.