Clinical trial NCT00420238: Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis
Official title: A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: Axial Ankylosing Spondylitis
Adult
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria

* Active and severe ankylosing spondylitis
* Ankylosing spondylitis refractory to standard anti-rheumatic treatment
* Between 18 and 70 years of age

Exclusion criteria

* Prior exposure to any TNF-inhibitor, including etanercept
* DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation
* Dose of NSAIDs changed within two weeks of study drug initiation

Primary outcomes:
measure: Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
Secondary outcomes:
measure: Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Total Back Pain at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)
timeFrame: Baseline, Week 12
measure: Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12
measure: Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
measure: Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24
timeFrame: Week 14, Week 18, Week 24
Other outcomes:
Locations:
city: Amiens
country: France
city: Arles
country: France
city: Avignon
country: France
city: Bordeaux
country: France
city: Cabestany
country: France
city: Corbeil Essonnes
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Orleans
country: France
city: Paris (Ambroise Pare)
country: France
city: Paris (Bichat)
country: France
city: Paris (COCHIN)
country: France
city: Paris (Pitie Salpetriere)
country: France
city: Paris (Saint Antoine)
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Herne
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Maastricht
country: Netherlands
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For France, infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, medinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Hungary: WPBUMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dougados M, Braun J, Szanto S, Combe B, Geher P, Leblanc V, Logeart I. Continuous efficacy of etanercept in severe and advanced ankylosing spondylitis: results from a 12-week open-label extension of the SPINE study. Rheumatology (Oxford). 2012 Sep;51(9):1687-96. doi: 10.1093/rheumatology/kes125. Epub 2012 May 30.
citation: Dougados M, Braun J, Szanto S, Combe B, Geher P, Leblanc V, Logeart I. Nonsteroidal antiinflammatory drug intake according to the Assessment of SpondyloArthritis International Society Score in clinical trials evaluating tumor necrosis factor blockers: example of etanercept in advanced ankylosing spondylitis. Arthritis Care Res (Hoboken). 2012 Feb;64(2):290-4. doi: 10.1002/acr.20671.
citation: Dougados M, Braun J, Szanto S, Combe B, Elbaz M, Geher P, Thabut G, Leblanc V, Logeart I. Efficacy of etanercept on rheumatic signs and pulmonary function tests in advanced ankylosing spondylitis: results of a randomised double-blind placebo-controlled study (SPINE). Ann Rheum Dis. 2011 May;70(5):799-804. doi: 10.1136/ard.2010.139261. Epub 2011 Feb 13.