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Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan

Last updated on November 19, 2019

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Study Location
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
11-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

· Patients with rheumatoid arthritis [only those refractory to the previous treatment]

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

· Patients with rheumatoid arthritis [only those refractory to the previous treatment]

NCT00503503
Pfizer
Completed
Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan

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Pfizer Clinical Trials Contact Center

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Descriptive Information
Brief TitleStudy Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan
Official TitleSafety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan
Brief SummaryThe objective of this surveillance is to determine the following items in all patients receiving Enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset (frequency, severity and other details) of adverse events, 3) factors considered to affect the safety, and 4) the efficacy of Enbrel. Moreover, the onset (frequency, severity and other details) of the followings will be key issues of this surveillance:Infection (tuberculosis, opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor, interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and application site reactions.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionRheumatoid Arthritis
InterventionDrug: Enbrel (etanercept)
Study Groups/CohortsNot Provided
Publications *Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, Takeuchi T, Tanaka Y, Yamanaka H, Fujii K, Freundlich B, Suzukawa M. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009 May;36(5):898-906. doi: 10.3899/jrheum.080791. Epub 2009 Mar 30.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
EnrollmentNot Provided
Original EnrollmentNot Provided
Actual Study Completion DateOctober 2007
Actual Primary Completion DateOctober 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria

· Patients with rheumatoid arthritis [only those refractory to the previous treatment]

Sex/Gender
Sexes Eligible for Study:All
Ages11 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00503503
Other Study ID Numbers0881Y1-4460
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

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

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Contact

[email protected]

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