N/A
N=132
Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT00900796 ↗Enrolled (actual)
132
Serious AEs
0.8%
Results posted
Jun 2012
Primary outcome: Primary: Percentage of Participants With a Clinical Response — 90.9; 9.1 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Treatment switching (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Clinical Response |
90.9; 9.1 | — |
| SECONDARY Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment |
66.7 | — |
| SECONDARY Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment |
— | — |
| SECONDARY Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16 |
96.4 | — |
| SECONDARY Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16 |
33.1 | — |
| SECONDARY Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy |
72.7 | — |
| SECONDARY Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks |
— | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT00900796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.