Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT00420238 |
Date of registration:
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08/01/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis
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Scientific title:
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A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis |
Date of first enrolment:
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January 2007 |
Target sample size:
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82 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00420238 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 4
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Countries of recruitment
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France
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Germany
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Hungary
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Netherlands
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Contacts
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Name:
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Trial Manager |
Address:
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Telephone:
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Email:
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Affiliation:
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For France, infomedfrance@wyeth.com |
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Name:
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Trial Manager |
Address:
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Telephone:
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Email:
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Affiliation:
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For Hungary: WPBUMED@wyeth.com |
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Name:
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Trial Manager |
Address:
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Telephone:
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Email:
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Affiliation:
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For Netherlands, trials-NL@wyeth.com |
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Name:
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Trial Manager |
Address:
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Telephone:
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Email:
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Affiliation:
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For Germany, medinfoDEU@wyeth.com |
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Name:
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Medical Monitor |
Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: Etanercept (Enbrel)
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Other: Placebo
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12
[Time Frame: Week 2, Week 4, Week 8, Week 12]
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Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12
[Time Frame: Week 2, Week 4, Week 8, Week 12]
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Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12
[Time Frame: Week 2, Week 4, Week 8, Week 12]
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Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in Total Back Pain at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12
[Time Frame: Week 2, Week 4, Week 8, Week 12]
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Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12
[Time Frame: Week 2, Week 4, Week 8, Week 12]
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Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12
[Time Frame: Week 2, Week 4, Week 8, Week 12]
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Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)
[Time Frame: Baseline, Week 12]
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Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12
[Time Frame: Week 2, Week 4, Week 8, Week 12]
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Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12
[Time Frame: Week 2, Week 4, Week 8, Week 12]
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Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12
[Time Frame: Week 2, Week 4, Week 8, Week 12]
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Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1)
[Time Frame: Baseline, Week 12]
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Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12
[Time Frame: Week 2, Week 4, Week 8, Week 12]
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Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24
[Time Frame: Week 14, Week 18, Week 24]
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Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12
[Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]
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Secondary ID(s)
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0881A3-403
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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