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| Name | Class |
|---|---|
| Lincoln Medical and Mental Health Center | OTHER |
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Study to assess whether etanercept therapy is able to increase flow-mediated vasodilatation in AS, and whether etanercept can modify the intima-media thickness (IMT) in these patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | etanercept 50 mg/week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Drug | etanercept 50 mg/week |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12 | Brachial artery (BA) FMD equals (=)(maximum diameter minus[-] baseline diameter divided by baseline diameter) times (*) 100 percent (%). Ultrasound images of BA at rest were followed by blood pressure (BP) cuff inflated to at least 50 millimeters of mercury (mm Hg) above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52 | BA FMD =(maximum diameter -baseline diameter divided by baseline diameter) * 100%. Ultrasound images of BA at rest were followed by BP cuff inflated to at least 50 mm Hg above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function. Change: Week x observation minus Baseline observation. |
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Inclusion Criteria:
Exclusion Criteria:
1. Pregnancy confirmed by test taken at screening in all women except those who were surgically sterile or at least 1 year postmenopausal. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception that needs to be continued for 15 days following discontinuation of the test article.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Bologna | 40138 | Italy | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks. |
| FG001 | Placebo | Participants received matched placebo sc injection once per week for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks. |
| BG001 | Placebo | Participants received matched placebo sc injection once per week for 52 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12 | Brachial artery (BA) FMD equals (=)(maximum diameter minus[-] baseline diameter divided by baseline diameter) times (*) 100 percent (%). Ultrasound images of BA at rest were followed by blood pressure (BP) cuff inflated to at least 50 millimeters of mercury (mm Hg) above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function. | Modified Intent to Treat Population (mITT): all randomized participants who received at least one dose of test article followed by at least one available evaluation; n=number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | percentage of BA diameter | Baseline, Week 12 |
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The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal mass | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth abscess | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
Due to early termination and few participants attending visits after Week 12, statistical analysis limited to Week 12.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Baseline, Weeks 4, 24, 36, and 52 or Early Termination (ET) |
| Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52 | Change in IMT in the distal common carotid arteries (CCA), common bulbs (CB), and internal carotid arteries (ICA) as determined by ultrasound. Higher scores indicate worsening in cardiovascular risk assessment. Change: Week x observation minus Baseline observation. | Baseline, Week 12 and 52 or ET |
| Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52 | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL) and Triglyceride (TGL) blood concentrations, lower values indicated improvement in cardiovascular risk. Mean High Density Lipoprotein (HDL), higher values indicated improvement in cardiovascular risk. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
| Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52 | Mean serum homocysteine blood concentrations. Lower values of homocysteine indicate improvement in inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52 | 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. Normal range is 0-30 mm/hour (hr). A higher rate is consistent with inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
| Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52 | CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52 | BASDAI a validated self assessment tool to determine disease activity in participant with Ankylosing Spondylitis (AS) using a Visual Analog Scale (VAS) of 0 (none) to 10 (very severe) centimeter (cm). Participant answered 6 questions measuring discomfort, pain and fatigue. Final BASDAI score averages the individual assessments for a final score range of 0-10. Change: Week x observation minus Baseline observation. Higher score indicates greater disability. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36, and 52 or ET |
| Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52 | BASDAI a validated self assessment tool used to determine disease activity in participants with AS. Utilizing a VAS of 0 (none) to 10 cm (very severe), participant's answered 6 questions measuring discomfort, pain and fatigue. BASDAI 50 response defined as at least a 50% improvement (decrease) from baseline in BASDAI. Baseline score - score at observation divided by Baseline score * 100 = greater than or equal to 50%. | Weeks 4, 12, 24, 36, and 52 or ET |
| Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change greater than or equal to (≥) 10 units on a 0-100 millimeter (mm) scale (0 mm = no disease activity; 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | Week 4, 12, 24, 36, and 52 or ET |
| Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | Weeks 4, 12, 24, 36, and 52 or ET |
| Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | Weeks 4, 12, 24, 36 and 52 or ET |
| Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | Weeks 4, 12, 24, 36 and 52 or ET |
| Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52 | ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 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. | Weeks 4, 12, 24, 36 and 52 or ET |
| Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52 | Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity. | Weeks 4, 12, 24, 36 and 52 or ET |
| Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52 | 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. Lower score indicated better spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
| Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52 | While in a neutral position, the participant turned the head as far as possible to the right and then to the left. Using a goniometer the degrees of movement were measured. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Actual rotation ranged from 3.0 to 99.0 degrees. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36, 52 or ET |
| Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52 | Measurement in cm of the distance between the medial malleoli when participant was lying supine with knees straight and feet pointed straight up with legs separated as far as possible, 2 attempts were measured. The best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
| Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52 | Measurement in cm of distance between marks originally placed while participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joins the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bent forward, knees fully extended, with supine in full flexion. The measurement was carried out two times and best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
| Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52 | Measurement in cm of distance between the tragus and wall from the right and left side while participant was standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in a neutral position. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the smallest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
| Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52 | Measurement in cm of distance between participant's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting to keep shoulders in same place (flexion position). Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
| Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52 | While participant stood with back against the wall and during maximal effort to touch head to the wall, the distance between the occiput (back of head) and the wall was measured. The measurement of two attempts was made and best of the two measurements which corresponds to the highest value were reported. Lower scores indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
| Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52 | Chest expansion defined as the difference in thoracic circumference during full expiration versus full inspiration, measured in cm at the fourth intercostal space (nipple line) while participant was standing. Measurement taken twice and best of the two measurements (corresponding to the highest value of inspiration and smallest value for expiration), were then averaged. Greater chest circumference indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
| Prato |
| 59100 |
| Italy |
| Pfizer Investigational Site | Reggio Emilia | 42100 | Italy |
| Pfizer Investigational Site | Roma | 00161 | Italy |
| Withdrawal by Subject |
|
| Discontinuation of study by sponsor |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
| OG001 | Placebo | Participants received matched placebo sc injection once per week for 52 weeks. |
|
|
|
| Secondary | Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52 | BA FMD =(maximum diameter -baseline diameter divided by baseline diameter) * 100%. Ultrasound images of BA at rest were followed by BP cuff inflated to at least 50 mm Hg above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function. Change: Week x observation minus Baseline observation. | mITT; n=number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | percentage of BA diameter | Baseline, Weeks 4, 24, 36, and 52 or Early Termination (ET) |
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| Secondary | Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52 | Change in IMT in the distal common carotid arteries (CCA), common bulbs (CB), and internal carotid arteries (ICA) as determined by ultrasound. Higher scores indicate worsening in cardiovascular risk assessment. Change: Week x observation minus Baseline observation. | mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable | Posted | Mean | Standard Deviation | mm | Baseline, Week 12 and 52 or ET |
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| Secondary | Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52 | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL) and Triglyceride (TGL) blood concentrations, lower values indicated improvement in cardiovascular risk. Mean High Density Lipoprotein (HDL), higher values indicated improvement in cardiovascular risk. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable | Posted | Mean | Standard Deviation | millimole/Liter (mmol/L) | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52 | Mean serum homocysteine blood concentrations. Lower values of homocysteine indicate improvement in inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; n= number of participants evaluable at specific time point; N=number of participants evaluable | Posted | Mean | Standard Deviation | micromole/liter (µmol/L) | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52 | 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. Normal range is 0-30 mm/hour (hr). A higher rate is consistent with inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | mm/hr | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52 | CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | mg/liter (mg/L) | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52 | BASDAI a validated self assessment tool to determine disease activity in participant with Ankylosing Spondylitis (AS) using a Visual Analog Scale (VAS) of 0 (none) to 10 (very severe) centimeter (cm). Participant answered 6 questions measuring discomfort, pain and fatigue. Final BASDAI score averages the individual assessments for a final score range of 0-10. Change: Week x observation minus Baseline observation. Higher score indicates greater disability. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; n= number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Weeks 4, 12, 24, 36, and 52 or ET |
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| Secondary | Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52 | BASDAI a validated self assessment tool used to determine disease activity in participants with AS. Utilizing a VAS of 0 (none) to 10 cm (very severe), participant's answered 6 questions measuring discomfort, pain and fatigue. BASDAI 50 response defined as at least a 50% improvement (decrease) from baseline in BASDAI. Baseline score - score at observation divided by Baseline score * 100 = greater than or equal to 50%. | mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point | Posted | Number | percentage of participants | Weeks 4, 12, 24, 36, and 52 or ET |
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| Secondary | Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change greater than or equal to (≥) 10 units on a 0-100 millimeter (mm) scale (0 mm = no disease activity; 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point | Posted | Number | percentage of participants | Week 4, 12, 24, 36, and 52 or ET |
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| Secondary | Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point | Posted | Number | percentage of participants | Weeks 4, 12, 24, 36, and 52 or ET |
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| Secondary | Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | mITT; N=number of participants with evaluable; n=number of participants evaluable at specific time point | Posted | Number | percentage of participants | Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point | Posted | Number | percentage of participants | Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52 | ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 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. | mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point | Posted | Number | percentage of participants | Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52 | Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity. | mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point | Posted | Number | percentage of participants | Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52 | 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. Lower score indicated better spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; n=number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52 | While in a neutral position, the participant turned the head as far as possible to the right and then to the left. Using a goniometer the degrees of movement were measured. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Actual rotation ranged from 3.0 to 99.0 degrees. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; n= number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | degrees of movement | Baseline, Weeks 4, 12, 24, 36, 52 or ET |
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| Secondary | Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52 | Measurement in cm of the distance between the medial malleoli when participant was lying supine with knees straight and feet pointed straight up with legs separated as far as possible, 2 attempts were measured. The best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; n= number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | cm | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52 | Measurement in cm of distance between marks originally placed while participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joins the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bent forward, knees fully extended, with supine in full flexion. The measurement was carried out two times and best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; n= number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | cm | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52 | Measurement in cm of distance between the tragus and wall from the right and left side while participant was standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in a neutral position. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the smallest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; n= number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | cm | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52 | Measurement in cm of distance between participant's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting to keep shoulders in same place (flexion position). Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; n= number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | cm | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52 | While participant stood with back against the wall and during maximal effort to touch head to the wall, the distance between the occiput (back of head) and the wall was measured. The measurement of two attempts was made and best of the two measurements which corresponds to the highest value were reported. Lower scores indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; n= number of participants evaluable at specific time point | Posted | Mean | Standard Deviation | cm | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
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| Secondary | Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52 | Chest expansion defined as the difference in thoracic circumference during full expiration versus full inspiration, measured in cm at the fourth intercostal space (nipple line) while participant was standing. Measurement taken twice and best of the two measurements (corresponding to the highest value of inspiration and smallest value for expiration), were then averaged. Greater chest circumference indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection. | mITT; n= number of participants evaluable at specific time point; Due to limited number of participants with visits after Week 12 analysis limited to Week 12 | Posted | Mean | Standard Deviation | cm | Baseline, Weeks 4, 12, 24, 36 and 52 or ET |
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|
| 1 |
| 18 |
| 9 |
| 18 |
| EG001 | Placebo | Participants received matched placebo sc injection once per week for 52 weeks. | 0 | 16 | 3 | 16 |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Febrile infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| Change at Week 36 (n=7, 4) |
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| Change at Week 52 (n=4, 3) |
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| CCA Change at Week 52 (n=4, 2) |
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| CB Baseline (n=17, 14) |
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| CB Change at Week 12 (n=16, 11) |
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| CB Change at Week 52 (n=4, 2) |
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| ICA Baseline (n=17, 14) |
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| ICA Change at Week 12 (n=16, 11) |
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| ICA Change at Week 52 (n=4, 2) |
|
| ANCOVA |
| 0.513 |
| Mean Difference (Final Values) |
| -0.03 |
| 2-Sided |
| 95 |
| -0.13 |
| 0.07 |
| No |
| Superiority or Other |
| Week 12; Internal Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12 | ANCOVA | 0.592 | Mean Difference (Final Values) | -0.03 | 2-Sided | 95 | -0.14 | 0.08 | No | Superiority or Other |
| TC Change at Week 12 (n=15, 12) |
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| TC Change at Week 24 (n=9, 4) |
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| TC Change at Week 36 (n=7, 4) |
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| TC Change at Week 52 (n=4, 3) |
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| LDL Baseline (n=16, 15) |
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| LDL Change at Week 4 (n=15, 12) |
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| LDL Change at Week 12 (n=15, 12) |
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| LDL Change at Week 24 (n=9, 4) |
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| LDL Change at Week 36 (n=7, 4) |
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| LDL Change at Week 52 (n=4, 3) |
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| HDL Baseline (n=16, 15) |
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| HDL Change at Week 4 (n=15, 12) |
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| HDL Change at Week 12 (n=15, 12) |
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| HDL Change at Week 24 (n=9, 4) |
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| HDL Change at Week 36 (n=7, 4) |
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| HDL Change at Week 52 (n=4, 3) |
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| TGL Baseline (n=16, 15) |
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| TGL Change at Week 4 (n=15, 12) |
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| TGL Change at Week 12 (n=15, 12) |
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| TGL Change at Week 24 (n=9, 4) |
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| TGL Change at Week 36 (n=7, 4) |
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| TGL Change at Week 52 (n=4, 3) |
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| Change at Week 12 (n=15, 12) |
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| Change at Week 24 (n=8, 4) |
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| Change at Week 36 (n=7, 4) |
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| Change at Week 52 (n=4, 3) |
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| Change at Week 12 (n=15, 12) |
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| Change at Week 24 (n=9, 4) |
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| Change at Week 36 (n=7, 4) |
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| Change at Week 52 (n=5, 3) |
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| Change at Week 12 (n=14, 12) |
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| Change at Week 24 (n=9, 4) |
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| Change at Week 36 (n=7, 4) |
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| Change at Week 52 (n=5, 3) |
|
| Change at Week 12 (n=16, 13) |
|
| Change at Week 24 (n=9, 4) |
|
| Change at Week 36 (n=8, 4) |
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| Change at Week 52 (n=5, 2) |
|
| Mixed Models Analysis |
| 0.021 |
| Mean Difference (Final Values) |
| -2.02 |
| 2-Sided |
| 95 |
| -3.70 |
| -0.33 |
Adjusted mean difference (Etanercept-Placebo) |
| No |
| Superiority or Other |
| Week 24 (n=9, 4) |
|
| Week 36 (n=8, 4) |
|
| Week 52 (n=5, 2) |
|
| Week 24 (n=9, 4) |
|
| Week 36 (n=8, 4) |
|
| Week 52 (n=5, 2) |
|
| Week 24 (n=9, 4) |
|
| Week 36 (n=8, 4) |
|
| Week 52 (n=5, 2) |
|
| Week 24 (n=9, 4) |
|
| Week 36 (n=8, 4) |
|
| Week 52 (n=5, 2) |
|
| Week 24 (n=9, 4) |
|
| Week 36 (n=8, 4) |
|
| Week 52 (n=5, 2) |
|
| Week 24 (n=9, 4) |
|
| Week 36 (n=8, 4) |
|
| Week 52 (n=5, 2) |
|
| Week 24 (n=8, 4) |
|
| Week 36 (n=7, 4) |
|
| Week 52 (n=4, 2) |
|
| Change at Week 12 (n=16, 12) |
|
| Change at Week 24 (n=9, 4) |
|
| Change at Week 36 (n=8, 4) |
|
| Change at Week 52 (n=5, 3) |
|
| Mixed Models Analysis |
| 0.029 |
| Mean Difference (Final Values) |
| -0.91 |
| 2-Sided |
| 95 |
| -1.72 |
| -0.10 |
Adjusted mean difference (Etanercept-Placebo) |
| No |
| Superiority or Other |
| Change at Week 12 (n=16, 12) |
|
| Change at Week 24 (n=9, 4) |
|
| Change at Week 36 (n=8, 4) |
|
| Change at Week 52 (n=5, 3) |
|
| Change at Week 12 (n=16, 12) |
|
| Change at Week 24 (n=9, 4) |
|
| Change at Week 36 (n=8, 4) |
|
| Change at Week 52 (n=5, 3) |
|
| Change at Week 12 (n=16, 12) |
|
| Change at Week 24 (n=9, 4) |
|
| Change at Week 36 (n=8, 4) |
|
| Change at Week 52 (n=5, 3) |
|
| Change at Week 12(n=16, 12) |
|
| Change at Week 24 (n=9, 4) |
|
| Change at Week 36 (n=8, 4) |
|
| Change at Week 52 (n=5, 3) |
|
| Change at Week 12(n=16, 12) |
|
| Change at Week 24 (n=9, 4) |
|
| Change at Week 36 (n=8, 4) |
|
| Change at Week 52 (n=5, 3) |
|
| Change at Week 12 (n=16, 12) |
|
| Change at Week 24 (n=9, 4) |
|
| Change at Week 36 (n=8, 4) |
|
| Change at Week 52 (n=5, 3) |
|
| Mixed Models Analysis |
| 0.048 |
| Mean Difference (Final Values) |
| -1.28 |
| 2-Sided |
| 95 |
| -2.55 |
| -0.01 |
Adjusted mean difference (Etanercept-Placebo) |
| No |
| Superiority or Other |
| Change at Week 12 (n=16, 12) |
|
| Change at Week 24 (n=9, 4) |
|
| Change at Week 36 (n=8, 4) |
|
| Change at Week 52 (n=5, 3) |
|
| Mixed Models Analysis |
| 0.204 |
| Mean Difference (Final Values) |
| 0.89 |
| 2-Sided |
| 95 |
| -0.52 |
| 2.30 |
Adjusted mean difference (Etanercept-Placebo) |
| No |
| Superiority or Other |