NCT01230177

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

Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Implemented as a Special Investigation by Central Registration System

Conditions

• Arthritis
• Rheumatoid

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-10-28
• Last updated: 2017-02-23
• Results posted: 2017-02-23

Locations

1 site across 1 country: Japan