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Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

Last updated on October 13, 2019

FOR MORE INFORMATION
Study Location
Klinikum Benjamin Franklin
Berlin, , 12200 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
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

- Diagnosis of ankylosing spondylitis (AS)

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

- Hypersensitivity to etanercept

- Active infection including chronic or localised infection

- Sepsis or risk of sepsis

NCT00544557
Pfizer
Completed
Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

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Descriptive Information
Brief TitleStudy Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis
Official TitleObservational Study Of The Use Of Enbrel (Registered) (Etanercept) In Routine Clinical Practice To Treat Ankylosing Spondylitis (as) Patients: An Effectiveness, Safety, And Health Economic Evaluation
Brief SummaryThis study aims to provide a holistic assessment of patients receiving etanercept in a real-world setting.
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 PopulationPatients with an established diagnosis of Ankylosing Spondylitis
ConditionAnkylosing Spondylitis
InterventionDrug: Etanercept
The patients will be treated in accordance with the requirements of the labeling of etanercept 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 Ankylosing Spondylitis
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 24, 2014)
1715
Original Enrollment
 (submitted: October 15, 2007)
1800
Actual Study Completion DateMay 2014
Actual Primary Completion DateMay 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of ankylosing spondylitis (AS)

Exclusion Criteria:

  • Hypersensitivity to etanercept
  • Active infection including chronic or localised infection
  • Sepsis or risk of sepsis
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 NumberNCT00544557
Other Study ID Numbers0881X1-4463
B1801087 ( 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 DateApril 2015

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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