Success and Failure of Biological Therapy: Predictors of Response in Patients With Active Ankylosing Spondylitis
18 Years
N/A
Both
Ankylosing Spondylitis
Trial Information
Success and Failure of Biological Therapy: Predictors of Response in Patients With Active Ankylosing Spondylitis
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
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)
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Percentage of Participants With a Clinical Response
Outcome Description:
Assessment of clinical response was as per investigator's discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it.
Outcome Time Frame:
Week 16
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study ID:
0881A3-4452
NCT ID:
NCT00900796
Start Date:
March 2009
Completion Date:
May 2011
Related Keywords:
- Ankylosing Spondylitis
- Ankylosing spondylitis;predictive factors
- Spondylitis
- Spondylitis, Ankylosing
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