Extension Study Evaluating Etanercept in Ankylosing Spondylitis

Phase 4 Completed 84 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedSingle-groupOpen-labelTreatment

Summary

The primary purpose of this study is to evaluate the health care resource utilization and work status of patients with ankylosing spondylitis undergoing treatment with etanercept by comparing study evaluations with the baseline evaluations in the ASCEND (0881A3-402)(NCT00247962) study.

Timeline

Start: 2006-12
Primary completion: 2008-10
Completion: 2008-10

Outcome

Mixed primary results

registry p = 0.005; Fisher Exact; note: Comparison of Visit to physiotherapist 48 weeks before treatment Vs. Visit to physiotherapist during 48 treatment weeks NCT00410046 ↗

registry p = 0.576; Fisher Exact; note: Comparison of Sick leave 48 weeks before treatment Vs. Sick leave during 48 weeks of treatment NCT00410046 ↗

Publications

Baraliakos X, Szumski AE, Kwok KK, Vlahos B, Borlenghi CE. Long-term Etanercept Response for Patients with Radiographic Axial Spondyloarthritis Based on Achievement of Early, Intermediate, or Late Responses During Index Studies. Rheumatol Ther. 2024 Jun;11(3):583-597. doi: 10.1007/s40744-024-00656-3. Epub 2024 Mar 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etanercept	Protein / enzyme biologic	50 mg	Subcutaneous