Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain
- Conditions
- Ankylosing Spondylitis
- Interventions
- Drug: etanercept/placebo
- Registration Number
- NCT00873730
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis (AS) and previous failure to usual practice therapies in Spain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 etanercept - 2 etanercept/placebo -
- Primary Outcome Measures
Name Time Method Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20. 12 weeks ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
- Secondary Outcome Measures
Name Time Method Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40. 12 weeks ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50. 12 weeks ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70. 12 weeks ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6. 12 weeks ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0=no disease activity, 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.
Number of Patients Achieving Partial Remission. 12 weeks Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0=no disease activity, 100=high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.
Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12. Baseline and 12 weeks Nocturnal back and overall spinal pain assessed by patients using a Visual Analog Scale (VAS) of 0 - 10 (0 = no pain and 10 = most severe pain).
Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12. Baseline and 12 weeks Patient pain assessed by physician and patient using a Visual Analog Scale (VAS) of 0 - 10 (0 = none and 10 = severe).
Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12. Baseline and 12 weeks BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12. Baseline and 12 weeks BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12. Baseline and 12 weeks BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12. Baseline and 12 weeks ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube and is measured in mm/hour. Normal range is 0-30mm/h. A higher rate is consistent with inflammation.
Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire 12 weeks EuroQol questionnaire is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to every question were grouped in two main categories: with problems (having some problems or absolutely unable) or without problems.
Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12. Baseline and 12 weeks SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms 12 weeks Change in C-reactive Protein (CRP) From Baseline to Week 12. Baseline and 12 weeks CRP is a marker of inflammation and measured in mg/l. A higher level is consistent with inflammation.