Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan

NCT00503139

Last updated date
Study Location
Hokkaido University Hospital
Sapporo, , 060-8638, Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following

1. Patients who are refractory to the treatment.

2. Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted.

3. Patients without a history of or concurrent malignant tumors.

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

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Advanced Information
Descriptive Information
Brief Title Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan
Official Title Enbrel Special Use Result Surveillance
Brief Summary The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in the long-term use.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospital and Rheumatology clinic
Condition Rheumatoid Arthritis
Intervention Drug: Enbrel (etanercept)
Enbrel 10 to 25 mg twice a week subcutaneous injection
Study Groups/Cohorts Not Provided
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: August 22, 2011)
684
Original Enrollment Not Provided
Actual Study Completion Date April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following

  1. Patients who are refractory to the treatment.
  2. Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted.
  3. Patients without a history of or concurrent malignant tumors.

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study:All
Ages 10 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 NCT00503139
Other Study ID Numbers 0881A1-4426
B1801045 ( Other Identifier: Alias Study Number )
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