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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Taihaku Sakura Hospital
Sendai, Miyagi, 982-0032 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis, Rheumatoid
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

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

NCT01230177
Pfizer
Completed
Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)

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[email protected]

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Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)
Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)
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.
Implemented as a Special Investigation by Central Registration System
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.
  • Arthritis
  • Rheumatoid
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.
Other Name: Enbrel
Etanercept (genetical recombination)
Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.
Intervention: Drug: etanercept (genetical recombination)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01230177
B1801134
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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