N/A N=80

Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.

Ankylosing Spondylitis

Bottom Line

View on ClinicalTrials.gov: NCT01421303 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline — 30.18; 49.09; 53.06; 63.29 Percentage of impairment

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Enbrel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline	30.18; 49.09; 53.06; 63.29	—
PRIMARY Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6	6.23; 27.97; 28.07; 31.81	—
PRIMARY Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12	5.52; 25.18; 23.97; 29.55	—
PRIMARY Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18	1.06; 24.89; 24.65; 30.18	—
PRIMARY Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24	6.31; 24.88; 25.88; 30.18	—
SECONDARY Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24	-22.61; -22.05; -24.68; -31.53; -27.11; -29.63	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Baseline	0.21; 0.60; 0.62; 0.62	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24	0.23; 0.62; 0.56; 0.55; 0.41; 0.42	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Baseline	0.29; 0.59; 0.58; 0.54	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24	0.36; 0.56; 0.62; 0.62; 0.37; 0.47	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Baseline	0.06; 0.30; 0.23; 0.08	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24	0.17; 0.26; 0.12; 0.31; -0.088; 0.34	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline	0.21; 0.48; 0.48; 0.61	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24	0.34; 0.56; 0.55; 0.64; 0.25; 0.28	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Baseline	-0.52; -0.52; -0.57; -0.43	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24	-0.41; -0.36; -0.36; -0.57; -0.52; -0.25	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Baseline	-0.06; -0.38; -0.41; -0.51	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24	-0.19; -0.33; -0.45; -0.29; 0.038; -0.006	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Baseline	-0.17; -0.58; -0.59; -0.52	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24	-0.19; -0.60; -0.59; -0.33; 0.007; -0.33	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Baseline	-0.06; -0.42; -0.47; -0.59	—
SECONDARY Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24	-0.15; -0.57; -0.62; -0.54; 0.009; -0.32	—

Summary

Patients with Ankylosing spondylitis more frequently discontinue work. This study measures the impact of Enbrel on work participation.

Eligibility Criteria

Inclusion Criteria

Active AS patients (as judged by the treating MD) who are currently employed.
Patients who are scheduled by their rheumatologist to initiate treatment with Etanercept.

Exclusion Criteria

Patients who initiated a procedure for eligibility of work disability/pension.
Patients with previous use of TNF-alpha inhibitors either in commercial use, or in a study for the treatment of AS or a related spondylarthropathy condition.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01421303). 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.