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Trial record 27 of 298 for:    "Ankylosing spondylitis"

Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain (Loadet)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00873730
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : August 13, 2009
Last Update Posted : April 28, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Interventions Drug: etanercept
Drug: etanercept/placebo
Enrollment 108
Recruitment Details Patients were recruited in Spain from December 2006 to February 2008.
Pre-assignment Details Patients were screened up to 6 weeks.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description etanercept 50 mg twice a week (BIW) for 12 weeks etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Period Title: Overall Study
Started 54 54
Completed 48 49
Not Completed 6 5
Reason Not Completed
Protocol Deviation             5             2
Adverse Event             0             2
Withdrawal by Subject             0             1
Sponsor decision             1             0
Arm/Group Title Etanercept BIW Etanercept QW Total
Hide Arm/Group Description etanercept 50 mg twice a week (BIW) for 12 weeks etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 54 54 108
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 54 participants 108 participants
40.22  (10.36) 42.63  (10.66) 41.43  (10.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 108 participants
Female
11
  20.4%
11
  20.4%
22
  20.4%
Male
43
  79.6%
43
  79.6%
86
  79.6%
1.Primary Outcome
Title Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 48 49
Measure Type: Number
Unit of Measure: patients
34 37
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6031
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 48 49
Measure Type: Number
Unit of Measure: patients
25 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9166
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 48 49
Measure Type: Number
Unit of Measure: patients
22 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7564
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 48 49
Measure Type: Number
Unit of Measure: patients
15 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3266
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 48 49
Measure Type: Number
Unit of Measure: patients
20 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7481
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Number of Patients Achieving Partial Remission.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 48 49
Measure Type: Number
Unit of Measure: patients
14 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7721
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12.
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 48 49
Mean (Standard Deviation)
Unit of Measure: units on scale
Nocturnal Back Pain -3.96  (3.15) -4.15  (2.76)
Overall Spinal Pain -3.89  (2.99) -3.53  (2.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Nocturnal Back Pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6660
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Overall Spinal Pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5364
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12.
Hide Description Patient pain assessed by physician and patient using a Visual Analog Scale (VAS) of 0 – 10 (0 = none and 10 = severe).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 48 49
Mean (Standard Deviation)
Unit of Measure: units on scale
Physician Global Assessment -4.15  (1.77) -4.12  (1.39)
Patient Global Assessment -3.67  (3.13) -4.17  (2.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for the Physician Global Assessment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9426
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for the Patient Global Assessment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4969
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12.
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 48 49
Mean (Standard Deviation)
Unit of Measure: units on scale
-2.61  (2.64) -2.45  (2.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6687
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12.
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 48 49
Mean (Standard Deviation)
Unit of Measure: units on scale
-3.67  (2.18) -3.59  (2.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6739
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12.
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: units on scale
-0.46  (0.98) -0.80  (1.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2772
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12.
Hide Description 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.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 47 46
Mean (Standard Deviation)
Unit of Measure: mm/hour
-11.8  (14.47) -16.2  (16.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1560
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 47 49
Measure Type: Number
Unit of Measure: patients
Mobility Without Problems 37 33
Mobility With Problems 10 16
Self-care Without Problems 29 29
Self-care With Problems 18 20
Usual activities Without Problems 20 17
Usual activities With Problems 27 32
Pain/Discomfort Without Problems 5 13
Pain/Discomfort With Problems 42 36
Anxiety/Depression Without Problems 28 32
Anxiety/Depression With Problems 19 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Mobility.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2099
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Self-care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8009
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Usual activities.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4290
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Pain/Discomfort.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0461
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Anxiety/Depression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5620
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
14.Secondary Outcome
Title Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12.
Hide Description 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).
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat population. Two scored areas had a different “Number of Participants Analyzed” in the etanercept arm. Bodily pain had 45 and Emotional role limitations had 46.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 47 49
Mean (Standard Deviation)
Unit of Measure: units on scale
Physical functioning 15.53  (27.73) 19.90  (20.73)
Physical role limitations 30.32  (50.79) 32.14  (42.08)
Bodily pain -1.39  (22.31) -1.43  (24.02)
General health 7.23  (13.22) 9.59  (12.11)
Vitality 8.65  (13.61) 12.14  (14.58)
Social functioning 8.24  (16.75) 6.12  (20.59)
Emotional role limitations 17.39  (42.01) 17.01  (40.89)
Mental health 7.34  (11.53) 6.27  (11.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Physical functioning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3476
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Physical role limitations.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9045
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Bodily pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8558
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for General health.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3123
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Vitality.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3327
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Social functioning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8334
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Emotional role limitations.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7998
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments Analysis provided for Mental health.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7125
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
15.Secondary Outcome
Title Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this assessment was patients who had ocular inflammatory disease at baseline. The number of patients analyzed is zero because no patients had symptoms of ocular inflammatory disease at baseline.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Change in C-reactive Protein (CRP) From Baseline to Week 12.
Hide Description CRP is a marker of inflammation and measured in mg/l. A higher level is consistent with inflammation.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is the intent to treat.
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description:
etanercept 50 mg twice a week (BIW) for 12 weeks
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Overall Number of Participants Analyzed 45 44
Mean (Standard Deviation)
Unit of Measure: mg/l
-11.6  (18.42) -11.7  (21.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept BIW, Etanercept QW
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7404
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etanercept BIW Etanercept QW
Hide Arm/Group Description etanercept 50 mg twice a week (BIW) for 12 weeks etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
All-Cause Mortality
Etanercept BIW Etanercept QW
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept BIW Etanercept QW
Affected / at Risk (%) Affected / at Risk (%)
Total   1   2 
Gastrointestinal disorders     
Diarrheic syndrome *  0/54 (0.00%)  1/54 (1.85%) 
Diarrhea *  1/54 (1.85%)  0/54 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Viral respiratory infection *  0/54 (0.00%)  1/54 (1.85%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Etanercept BIW Etanercept QW
Affected / at Risk (%) Affected / at Risk (%)
Total   22   26 
Gastrointestinal disorders     
Abdominal pain *  2/54 (3.70%)  0/54 (0.00%) 
Diarrhea *  1/54 (1.85%)  2/54 (3.70%) 
General disorders     
Injection site reaction *  7/54 (12.96%)  8/54 (14.81%) 
Injury, poisoning and procedural complications     
Procedural dizziness *  1/54 (1.85%)  2/54 (3.70%) 
Investigations     
Transaminases increased *  4/54 (7.41%)  4/54 (7.41%) 
Nervous system disorders     
Dizziness *  2/54 (3.70%)  0/54 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasopharyngitis *  5/54 (9.26%)  8/54 (14.81%) 
Pharyngitis *  0/54 (0.00%)  2/54 (3.70%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: U. S. Contact Center
Organization: Wyeth
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00873730     History of Changes
Other Study ID Numbers: 0881A3-406
First Submitted: April 1, 2009
First Posted: April 2, 2009
Results First Submitted: June 30, 2009
Results First Posted: August 13, 2009
Last Update Posted: April 28, 2010