N/A
N=152
Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT01856569 ↗Enrolled (actual)
152
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18 — 85.42 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- no intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18 |
85.42 | — |
| PRIMARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18 |
3.84 | — |
| PRIMARY Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity |
60.19; 61.86 | — |
| SECONDARY Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18 |
5.4; 3.0 | — |
| SECONDARY C Reactive Protein Level at Baseline |
5.91 | — |
| SECONDARY Erythrocyte Sedimentation Rate at Baseline |
25.91 | — |
Summary
Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.
Eligibility Criteria
Inclusion Criteria
retrospective:12 months at least first anti-TNF therapy prospective: at maximum 6 months observation AS patients with axial involvement
Exclusion Criteria
patients in other AS studies involved
Data sourced from ClinicalTrials.gov (NCT01856569). 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.