Phase 4
N=566
Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT00247962 ↗Enrolled (actual)
566
Serious AEs
—
Results posted
Nov 2012
Primary outcome: Primary: Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) — 287; 99 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- etanercept (Drug); sulphasalazine (SSZ) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) |
287; 99 | <0.001 sig |
| SECONDARY Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline |
11.03; 11.32; 6.21; 9.06 | 0.719 |
Summary
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of ankylosing spondylitis
- Active ankylosing spondylitis
Exclusion Criteria
- Complete ankylosis of spine
- Previous treatment with etanercept
Data sourced from ClinicalTrials.gov (NCT00247962). 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.