Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

NCT01188655

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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

- Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines

- Patients treated as an outpatient

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


- Patients who suffer from hypersensitivity to the active substance Etanercept or to any
of the excipients of Enbrel®.


- Treatment with Enbrel® should not be initiated in patients with active infections
including chronic or localised infections.


- Patients with sepsis or risk of sepsis should not be treated.

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Advanced Information
Descriptive Information
Brief Title Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
Official Title Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis
Brief Summary This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.
Detailed Description The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The patient cohort in this non-interventional study will reflect the kind of patients seen in routine clinical practice and will not be specifically pre-selected as it is the case in clinical studies.
Condition Spondylitis, Ankylosing
Intervention Drug: Enbrel

The patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits.

Other Name: etanercept
Study Groups/Cohorts Treatment Group Enbrel
Intervention: Drug: Enbrel
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 Status Completed
Actual Enrollment
 (submitted: September 8, 2011)
89
Original Actual Enrollment
 (submitted: August 24, 2010)
66
Actual Study Completion Date March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
  • Patients treated as an outpatient

Exclusion Criteria:

  • Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®.
  • Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections.
  • Patients with sepsis or risk of sepsis should not be treated.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01188655
Other Study ID Numbers 0881X1-4456
B1801095
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2011