Phase 4 N=84 Randomized Treatment

Extension Study Evaluating Etanercept in Ankylosing Spondylitis

Ankylosing Spondylitis

Bottom Line

View on ClinicalTrials.gov: NCT00410046 ↗

Enrolled (actual)

Serious AEs

5.9%

Results posted

May 2012

Primary outcome: Primary: Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment — 6; 4; 8; 4 patients — p=0.743

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Enbrel (etanercept) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment	6; 4; 8; 4; 26; 11	0.743
PRIMARY Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment	27; 23	0.576
SECONDARY Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment	4; 2; 4; 4; 11; 6	1.0
SECONDARY Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment	6.13; 2.75; 6.13; 14.00; 11.41; 16.58	0.628
SECONDARY Number of Patients With Sick Leave During 48 Weeks Treatment	45; 13; 23; 10	1.00
SECONDARY Number of Sick Days Per Patient During the 48 Weeks of Treatment	37.67; 40.05	0.906
SECONDARY Change in Patient Global Assessment of Disease Activity From Baseline to Week 38	46.23; 36.08	—
SECONDARY Change in Total Back Pain Score From Baseline to Week 38	41.06; 34.17	—
SECONDARY Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38	32.95; 23.41	—
SECONDARY Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38	46.00; 31.13	—
SECONDARY Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38	1.21; 0.83	—
SECONDARY Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38	40.46; 29.88	—
SECONDARY Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38	7.64; 4.40	—
SECONDARY Change From Baseline Haywood Quality of Life Score From Baseline to Week 38	25.98; 16.14	—

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.

Eligibility Criteria

Inclusion criteria

Patients who completed 16 weeks of treatment and have completed the baseline health care resource utilization questionnaire at screening in the ASCEND study 0881A3-402-WW from participating countries.

Exclusion criteria

Withdrawal from the ASCEND study for safety or any other reason.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00410046). 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.