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Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Madrid, , 28006 Spain
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

- 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)

NCT00900796
Pfizer
Completed
Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis

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Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis
Success and Failure of Biological Therapy: Predictors of Response in Patients With Active Ankylosing Spondylitis
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.
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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with active ankylosing spondylitis treated in rheumatology units
Ankylosing Spondylitis
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
1
Patients diagnosed with active AS who start anti-TNF therapy according to standard clinical practice.
Intervention: Other: Treatment switching
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
May 2011
May 2011   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00900796
0881A3-4452
B1801100
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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