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

Last updated on October 16, 2019

FOR MORE INFORMATION
Study Location
Hokkaido University Hospital
Sapporo, , 060-8638 Japan
Contact
1-800-718-1021
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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Descriptive Information
Brief TitleStudy Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan
Official TitleEnbrel Special Use Result Surveillance
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationHospital and Rheumatology clinic
ConditionRheumatoid Arthritis
InterventionDrug: Enbrel (etanercept)
Enbrel 10 to 25 mg twice a week subcutaneous injection
Study Groups/CohortsNot 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 StatusCompleted
Actual Enrollment
 (submitted: August 22, 2011)
684
Original EnrollmentNot Provided
Actual Study Completion DateApril 2013
Actual Primary Completion DateApril 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
Ages10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00503139
Other Study ID Numbers0881A1-4426
B1801045 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2017

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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