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

NCT01230177

Last updated date
Study Location
Taihaku Sakura Hospital
Sendai, Miyagi, 982-0032, Japan
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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

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Advanced Information
Descriptive Information
Brief Title Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)
Official Title Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)
Brief 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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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.
Condition
  • 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.
Other Name: Enbrel
Study Groups/Cohorts 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 15, 2013)
3
Original Estimated Enrollment
 (submitted: October 27, 2010)
30
Actual Study Completion Date April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01230177
Other Study ID Numbers B1801134
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2017