A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis

Wyeth is now a wholly owned subsidiary of Pfizer0 sites82 target enrollmentJanuary 2007

ConditionsAnkylosing Spondylitis

InterventionsEtanercept (Enbrel)Placebo

DrugsEtanercept (Enbrel)

Overview

Phase: Phase 4
Intervention: Etanercept (Enbrel)
Conditions: Ankylosing Spondylitis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 82
Primary Endpoint: Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

May 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

A

Intervention: Etanercept (Enbrel)

B

Intervention: Placebo

Outcomes

Primary Outcomes

Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12

Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12

BASDAI subject asessment of discomfort, pain and fatigue measured using a 100 millimeter Visual Analog Scale; range: 0=none to 100=very severe. Normalized net incremental area under the curve (AUC) = area between baseline and the BASDAI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.

Secondary Outcomes

Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response(Baseline, Week 2, Week 4, Week 8, Week 12)
Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in Total Back Pain at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1)(Baseline, Week 12)
Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)(Baseline, Week 12)
Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24(Week 14, Week 18, Week 24)