N/A
N=89
Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
Spondylitis, Ankylosing
Bottom Line
View on ClinicalTrials.gov: NCT01188655 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Percentage of Participants Achieving BASDAI 40 Response at Week 24 — 83.6 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Enbrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving BASDAI 40 Response at Week 24 |
83.6 | — |
| SECONDARY Change From Baseline in BASDAI at Week 12 and 24 |
-2.8; -3.5 | — |
| SECONDARY Change From Baseline in the BASFI at Weeks 12 and 24 |
-2.1; -2.7 | — |
| SECONDARY Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24 |
2.8; 1.9 | — |
| SECONDARY Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24 |
2.5; 1.7 | — |
| SECONDARY Mean Duration of Morning Stiffness |
34.2; 30.0 | — |
| SECONDARY Change From Baseline in ASQoL at Week 12 and Week 24 |
-6.8; -8.3 | — |
| SECONDARY Percentage of Participants Without Enthesitis |
86.4; 85.9 | — |
| SECONDARY Percentage of Participants Without Peripheral Arthritis |
81.5; 85.9 | — |
| SECONDARY Mean Occiput-to-wall Distance at Week 12 and Week 24 |
3.2; 3.2 | — |
| SECONDARY Spine Agility Function by Schober Test |
7.6; 7.7 | — |
| SECONDARY Spine Agility Function by Ott Test |
13.6; 13.3 | — |
Summary
This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.
Eligibility Criteria
Inclusion Criteria
- Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
- Patients treated as an outpatient
Exclusion Criteria
- Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®.
- Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections.
- Patients with sepsis or risk of sepsis should not be treated.
Data sourced from ClinicalTrials.gov (NCT01188655). 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.