CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 566 enrolled
Drug / intervention
etanercept +1 moredrug
Likely dose
Etanercept 50 mg; Sulphasalazine titrated to 3 g daily (0.5 g daily increasing by 0.5 g weekly to reach 3 g by week 5)AI-extracted
Key inclusion· 2
  • ✓Clinical diagnosis of ankylosing spondylitis
  • ✓Active ankylosing spondylitis
Key exclusion· 2
  • ✕Complete ankylosis of spine
  • ✕Previous treatment with etanercept

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00247962
NCT00247962Phase 4Completed
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A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Nov 2, 2005·Updated Nov 8, 2012

In Brief

A Phase 4 clinical trial evaluating etanercept and sulphasalazine (SSZ) for Ankylosing Spondylitis. Completed, enrolled 566 participants across 83 sites in 18 countries.

Detailed Summary

The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis
CountriesAustralia, Austria, China, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Qatar, Saudi Arabia, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2, 2005
Enrollment StartDec 1, 2005
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 20.7 years ago

Interventions

etanerceptdrug

50 mg

sulphasalazine (SSZ)drug

Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.