Success and Failure of Biological Therapy: Predictors of Response in Patients With Active Ankylosing Spondylitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ankylosing Spondylitis
- Sponsor
- Pfizer
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With a Clinical Response
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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
Investigators
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)
Outcomes
Primary Outcomes
Percentage of Participants With a Clinical Response
Time Frame: Week 16
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.
Secondary Outcomes
- Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment(Week 32)
- Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment(Week 32)
- Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16(Week 16)
- Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16(Week 16)
- Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy(Week 16)
- Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks(Week 32)