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

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NCT00503139

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Hokkaido University Hospital
Sapporo, , 060-8638 Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
NCT00503139
Pfizer
Completed
Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan

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Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan
Enbrel Special Use Result Surveillance
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Hospital and Rheumatology clinic
Rheumatoid Arthritis
Drug: Enbrel (etanercept)
Enbrel 10 to 25 mg twice a week subcutaneous injection
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
684
April 2013
April 2013   (Final data collection date for primary outcome measure)

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:
Sexes Eligible for Study: All
10 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00503139
0881A1-4426
B1801045 ( Other Identifier: Alias Study Number )
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

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Contact

[email protected]



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