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Observational Trial With Enbrel

Last updated on October 11, 2019

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Study Location
Pfizer Investigational Site
Muenster, NRW, 48149 Germany
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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Clinical diagnosis of rheumatoid arthritis

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

- Sepsis or risk for sepsis,

- Acute infection,

- Hypersensitivity against Etanercept

NCT00488475
Pfizer
Completed
Observational Trial With Enbrel

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Descriptive Information
Brief TitleObservational Trial With Enbrel
Official TitleA 1 Year Observational Study of the Use of Etanercept in Routine German Clinical Practice to Treat Rheumatoid Arthritis Patients: a Health Economic, Safety and Effectiveness Evaluation
Brief SummaryThe diagnosis, evaluation and treatment of rheumatoid arthritis (RA) continue to undergo rapid change. Randomized controlled trials such as the TEMPO study have demonstrated the efficacy and safety of the combination of etanercept and methotrexate. Importantly, the TEMPO study showed that patients treated with etanercept and methotrexate could reach the newer therapeutic goals of low disease activity and remission, and that the physicians, patients, and payers are no longer prepared to accept the goal of "Reduction of symptoms". RCT are important and powerful tools in assessing efficacy and safety but have their limitations in terms of generalisability. In order to assess health economics, clinical effectiveness and safety of etanercept, they need to be measured by performing observational studies of unselected patients. This study aims to provide a holistic assessment of patients receiving etanercept in a real world setting. This will include centers that would not normally take part in RCT. The study will assess treatment with etanercept with descriptive statistics of the following parameters: Health economic, Safety, Effectiveness. In addition, there was a previous study of similar design, but of only 3 months duration (101354), which will allow comparison with historical data. Since previous study, there have been a number of significant changes: Introduction of a new formulation for etanercept (Enbrel® 50mg · once weekly), Definition of early RA has been modified to short disease duration (from 3 months to 1 year).
Detailed DescriptionNon-interventional study: subjects to be selected according to the usual clinical practice of their physician
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationOnly patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Rheumatoid Arthritis
ConditionRheumatoid Arthritis
InterventionDrug: etanercept
The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
Other Name: Enbrel
Study Groups/CohortsPatients with Rheumatoid Arthritis
Intervention: Drug: etanercept
Publications *Druce KL, Aikman L, Dilleen M, Burden A, Szczypa P, Basu N. Fatigue independently predicts different work disability dimensions in etanercept-treated rheumatoid arthritis and ankylosing spondylitis patients. Arthritis Res Ther. 2018 May 29;20(1):96. doi: 10.1186/s13075-018-1598-8.


*   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: July 25, 2014)
4945
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:

  • Clinical diagnosis of rheumatoid arthritis

Exclusion Criteria:

  • Sepsis or risk for sepsis,
  • Acute infection,
  • Hypersensitivity against Etanercept
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGermany
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00488475
Other Study ID Numbers0881A1-102335
B1801121
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 DateJuly 2014

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