Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00420238
• Date of registration: 08/01/2007
• Prospective Registration: No
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis
• Scientific 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
• Date of first enrolment: January 2007
• Target sample size: 82
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00420238
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

France, Germany, Hungary, Netherlands

Contacts

• Name: Trial Manager
• Affiliation: For Netherlands, [e-mail]

• Name: Trial Manager
• Affiliation: For Germany, [e-mail]

• Name: Medical Monitor
• Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

• Name: Trial Manager
• Affiliation: For France, [e-mail]

• Name: Trial Manager
• Affiliation: For Hungary: [e-mail]

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Etanercept (Enbrel)

Other: Placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12 [Time Frame: Week 2, Week 4, Week 8, Week 12]

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]

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]

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]

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]

Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

Change From Baseline in Total Back Pain at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

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]

Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%) [Time Frame: Baseline, Week 12]

Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12 [Time Frame: Week 2, Week 4, Week 8, Week 12]

Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

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]

Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

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]

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]

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]

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]

Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

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]

Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12 [Time Frame: Week 2, Week 4, Week 8, Week 12]

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]

Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

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]

Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

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]

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]

Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

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]

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]

Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

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]

Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 [Time Frame: Week 14, Week 18, Week 24]

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]

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]

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]

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]

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]

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]

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]

Secondary ID(s)

0881A3-403

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/06/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00420238