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CompletedNCT00458185Updated Mar 13, 2008

Study Evaluating Etanercept in Patients With Ankylosing Spondylitis

A Phase 4 interventional study of etanercept in Ankylosing Spondylitis, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-03-13.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer (part of Pfizer) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).

02

Conditions studied

  • Ankylosing Spondylitis
03

In context

Spondylitis, Ankylosing

507 studies on the registry are indexed under Spondylitis, Ankylosing; 91 are open to participants now.

This study's enrollment of 40 is below the median of 84 across 281 interventional studies indexed under Spondylitis, Ankylosing.

Browse Spondylitis, Ankylosing studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 484 studies on the registry; none are open to participants now.

First submitted before Wyeth became part of Pfizer.

Browse Wyeth studies →All Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis, aged between 18 and 70 years of age.
  • BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100).
  • Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal.

Exclusion criteria

Exclusion Criteria:

  • Complete ankylosis (fusion) of spine.
  • Previous receipt of etanercept, antibody to TNFα, or other TNFα inhibitors.
  • Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12.

Secondary outcomes

  1. Efficacy at 50% and 70% levels week 12; frequency and time to partial remission; safety; patient and physician global assessment, nocturnal and total back pain, BASFI, BASDAI; spinal mobility; complete joint assessment; hip involvement; ESR, CRP.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00458185
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Apr 9, 2007
Start date
Aug 2006
Completion
Apr 2007
Last update
Mar 13, 2008

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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