Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis

NCT00900796

Last updated date
Study Location
Pfizer Investigational Site
Madrid, , 28006, Spain
Contact
1-800-718-1021

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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

- Patients diagnosed of active AS who will start anti-TNF therapy following standard clinical practice as per summary of product characteristics doses.

- >18 years, both genders, any disease duration

- Signature of informed consent

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


- Previous treatment with biological therapies


- Active tuberculosis infection (local guidelines for appropriate screening and
treatment of tuberculosis in the setting of anti-TNF therapy must be followed)

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Advanced Information
Descriptive Information
Brief Title Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis
Official Title Success and Failure of Biological Therapy: Predictors of Response in Patients With Active Ankylosing Spondylitis
Brief Summary The objective of this observational study is to determine the incidence of response in patients with predictive factors of major clinical response in active ankylosing spondylitis (AS) in patients who start anti-tumor necrosis factor (anti-TNF) therapy and correlate these findings in patients who switch from one to another anti-TNF due to inefficacy under usual clinical practice conditions in Spain.
Detailed Description A sample size of 240 patients, 120 of them exposed and 120 not exposed to factors of response. Sample will be obtain from all the consecutive patients attending the rheumatology settings included in the study who fulfill the inclusion criteria
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with active ankylosing spondylitis treated in rheumatology units
Condition Ankylosing Spondylitis
Intervention Other: Treatment switching
If the patients do not response to first AntiTNF treatment, Investigator can switch to another anti TNF.Spanish Guidelines will be provided to the investigators, which recommend stopping biologics if there is an inadequate response after 16w of therapy and switch to another biologic. Responsive patients to the first anti-TNF who continue with this first anti-TNF adjusting dose treatment according to the Spanish guidelines or investigator criteria. The doses for each Anti TNF will be done following specific SmPc and under Investiagtor criteria
Study Groups/Cohorts 1
Patients diagnosed with active AS who start anti-TNF therapy according to standard clinical practice.
Intervention: Other: Treatment switching
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: April 4, 2012)
132
Original Estimated Enrollment
 (submitted: May 12, 2009)
240
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients diagnosed of active AS who will start anti-TNF therapy following standard clinical practice as per summary of product characteristics doses.
  • >18 years, both genders, any disease duration
  • Signature of informed consent

Exclusion Criteria:

  • Previous treatment with biological therapies
  • Active tuberculosis infection (local guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy must be followed)
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 Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT00900796
Other Study ID Numbers 0881A3-4452
B1801100
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 May 2012