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Trial record 16 of 17 for:    "Bone Disease" | "Sulfasalazine"

Extension Study Evaluating Etanercept in Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT00410046
Recruitment Status : Completed
First Posted : December 12, 2006
Results First Posted : May 11, 2012
Last Update Posted : May 11, 2012
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Intervention Drug: Enbrel (etanercept)
Enrollment 84
Recruitment Details Patients were recruited in Europe from November 2006 to January 2008.
Pre-assignment Details Patients in 0881A3-402 (NCT00247962) were randomized to receive etanercept (ETN) or sulphasalazine (SSZ). After completion, they were eligible for enrollment into this extension study and all patients received ETN. Outcome measure analysis kept the 0881A3-402 assignment of ETN or SSZ. This enabled an analysis of changes from the original baseline.
Arm/Group Title Etanercept
Hide Arm/Group Description Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Period Title: Overall Study
Started 84
Completed 79
Not Completed 5
Reason Not Completed
Adverse Event             3
Withdrawal by Subject             1
Lost to Follow-up             1
Arm/Group Title Etanercept
Hide Arm/Group Description Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Baseline Participants 84
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants
42.70  (10.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants
Female
13
  15.5%
Male
71
  84.5%
1.Primary Outcome
Title Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment
Hide Description Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).
Time Frame 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who took ETN and completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Arm/Group Title Etanercept / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: patients
Hospitalization 48 weeks before treatment 6
Hospitalization during 48 treatment weeks 4
Therapeutic warm bath 48 weeks before treatment 8
Therapeutic warm bath during 48 treatment weeks 4
Visit to physiotherapist 48 weeks before treatment 26
Visit to physiotherapist during 48 treatment weeks 11
Out-patient physician 48 weeks before treatment 40
Out-patient physician during 48 treatment weeks 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.743
Comments Comparison of Hospitalization 48 weeks before treatment Vs. Hospitalization during 48 treatment weeks
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN
Comments Comparison of percentages
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.362
Comments Comparison of Therapeutic warm bath 48 weeks before treatment Vs. Therapeutic warm bath during 48 treatment weeks
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Comparison of Visit to physiotherapist 48 weeks before treatment Vs. Visit to physiotherapist during 48 treatment weeks
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments Comparison of Out-patient physician 48 weeks before treatment Vs. Out-patient physician during 48 treatment weeks
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment
Hide Description Patients were asked whether or not they had taken sick leave during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).
Time Frame 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Arm/Group Title Etanercept / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: patients
Sick leave 48 weeks before treatment 27
Sick leave during 48 weeks of treatment 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.576
Comments Comparison of Sick leave 48 weeks before treatment Vs. Sick leave during 48 weeks of treatment
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment
Hide Description Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks of treatment.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 59 25
Measure Type: Number
Unit of Measure: patients
Admissions to hospital 4 2
Therapeutic warm bath sessions 4 4
Physiotherapist visits 11 6
Out-patient physician visit 30 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN, SSZ / ETN
Comments Admissions to hospital
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN, SSZ / ETN
Comments Therapeutic warm bath sessions
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN, SSZ / ETN
Comments Physiotherapist visits
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.567
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN, SSZ / ETN
Comments Out-patient physician visit
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment
Hide Description Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking all patients whether or not they had used the healthcare resource during the 48 weeks of treatment, and if so, how many times the resource was used. The mean number of times is based on those patients who responded to the questionnaire stating they had utilized healthcare resources (see outcome measure 3).
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed study 0881A3-402 (NCT00247962), continued into study 0881A3-405, received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 59 25
Mean (Full Range)
Unit of Measure: # of times utilized per patient
Inpatient hospitalization days per patient
6.13
(0.50 to 12.00)
2.75
(0.50 to 5.00)
Therapeutic warm bath sessions per patient
6.13
(0.50 to 15.00)
14.00
(5.00 to 26.00)
Physiotherapist visits per patient
11.41
(0.50 to 30.00)
16.58
(0.50 to 43.00)
Out-patient physician visit per patient
2.08
(0.50 to 10.00)
2.4
(0.00 to 6.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN, SSZ / ETN
Comments Inpatient hospitalization days per patient
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.628
Comments [Not Specified]
Method ANCOVA
Comments One-way ANCOVA, baseline was a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN, SSZ / ETN
Comments Therapeutic warm bath sessions per patient
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN, SSZ / ETN
Comments Physiotherapist visits per patient
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.361
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN, SSZ / ETN
Comments Out-patient physician visit per patient
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.816
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients With Sick Leave During 48 Weeks Treatment
Hide Description The impact of treatment on work productivity was assessed by sick leave. Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 59 25
Measure Type: Number
Unit of Measure: patients
Patients employed during the study 45 13
Patients with sick leave during the past 12 months 23 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN, SSZ / ETN
Comments Analysis completed for patients with sick leave during the past 12 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Number of Sick Days Per Patient During the 48 Weeks of Treatment
Hide Description Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days. The mean number of days is based on those patients who had sick leave during the treatment period.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 59 25
Mean (Full Range)
Unit of Measure: Sick days per patient
37.67
(0.50 to 232.00)
40.05
(2.00 to 252.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept / ETN, SSZ / ETN
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.906
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change in Patient Global Assessment of Disease Activity From Baseline to Week 38
Hide Description Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Time Frame Baseline and 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 52 24
Mean (Standard Deviation)
Unit of Measure: units on scale
46.23  (24.24) 36.08  (36.09)
8.Secondary Outcome
Title Change in Total Back Pain Score From Baseline to Week 38
Hide Description Total Back Pain was measured on a 0 to 100 mm VAS, with 0 mm indicating no pain. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Time Frame Baseline and 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 52 24
Mean (Standard Deviation)
Unit of Measure: units on scale
41.06  (28.52) 34.17  (31.40)
9.Secondary Outcome
Title Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38
Hide Description BASFI is a validated self assessment tool that determines the degree of functional limitation in Ankylosing Spodylitis (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, with a maximum score of 100 mm. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Time Frame Baseline and 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 52 24
Mean (Standard Deviation)
Unit of Measure: units on scale
32.95  (20.81) 23.41  (21.14)
10.Secondary Outcome
Title Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38
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 final BASDAI score averages the individual assessments for a final score range of 0-10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Time Frame Baseline and 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 52 24
Mean (Standard Deviation)
Unit of Measure: units on scale
46.00  (31.45) 31.13  (43.76)
11.Secondary Outcome
Title Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38
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. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Time Frame Baseline and 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 57 24
Mean (Standard Deviation)
Unit of Measure: units on scale
1.21  (1.40) 0.83  (1.31)
12.Secondary Outcome
Title Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38
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 fatigue-specific score is presented here. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Time Frame Baseline and 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 52 24
Mean (Standard Deviation)
Unit of Measure: units on scale
40.46  (25.53) 29.88  (34.33)
13.Secondary Outcome
Title Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38
Hide Description ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the patient as a ‘Yes’ (scored as 1) or ‘No’ (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). The 0881A3-402 baseline score was used as the baseline for this analysis. Change = baseline - week 38.
Time Frame Baseline and 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug, had at least 1 post-baseline assessment, and completed 38 weeks.
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 28 15
Mean (Standard Deviation)
Unit of Measure: units on scale
7.64  (5.88) 4.40  (6.19)
14.Secondary Outcome
Title Change From Baseline Haywood Quality of Life Score From Baseline to Week 38
Hide Description Haywood quality of life instrument was utilized in the United Kingdom as the ASQoL measure. The ASQoL is an AS-specific measure of QoL, scores range from 0 (good QoL) to 80 (poor QoL). ASQoL is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patient's 0881A3-402 baseline score was used in the analysis. Change=baseline-week 38.
Time Frame Baseline and 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients from United Kingdom sites who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug had at least 1 post-baseline assessment and completed 38 weeks.
Arm/Group Title Etanercept / ETN SSZ / ETN
Hide Arm/Group Description:
Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Overall Number of Participants Analyzed 27 14
Mean (Standard Deviation)
Unit of Measure: units on scale
25.98  (16.51) 16.14  (19.25)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etanercept
Hide Arm/Group Description Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
All-Cause Mortality
Etanercept
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept
Affected / at Risk (%)
Total   5/84 (5.95%) 
Gastrointestinal disorders   
Abdominal pain *  1/84 (1.19%) 
Ileitis *  1/84 (1.19%) 
Hepatobiliary disorders   
Liver function test abnormal *  1/84 (1.19%) 
Musculoskeletal and connective tissue disorders   
Spinal fracture *  1/84 (1.19%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lymphoma *  1/84 (1.19%) 
*
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 5%
Etanercept
Affected / at Risk (%)
Total   66/84 (78.57%) 
Blood and lymphatic system disorders   
Hemic and lymphatic system general *  7/84 (8.33%) 
Eye disorders   
Iritis *  5/84 (5.95%) 
Gastrointestinal disorders   
Digestive system general *  12/84 (14.29%) 
General disorders   
Accidental injury *  6/84 (7.14%) 
Flu syndrom *  5/84 (5.95%) 
Headache *  6/84 (7.14%) 
Infection *  10/84 (11.90%) 
Injection site reaction *  5/84 (5.95%) 
Pain *  5/84 (5.95%) 
Musculoskeletal and connective tissue disorders   
Arthralgia *  5/84 (5.95%) 
Arthritis *  7/84 (8.33%) 
Nervous system disorders   
Nervous system general *  8/84 (9.52%) 
Respiratory, thoracic and mediastinal disorders   
Pharyngitis *  6/84 (7.14%) 
Upper respiratory system general *  23/84 (27.38%) 
Skin and subcutaneous tissue disorders   
Skin and appendages general *  6/84 (7.14%) 
*
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
Layout table for Results Point of Contact information
Name/Title: U. S. Contact Center
Organization: Wyeth
EMail: clintrialresults@wyeth.com
Layout table for additonal information
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00410046     History of Changes
Other Study ID Numbers: 0881A3-405
First Submitted: December 8, 2006
First Posted: December 12, 2006
Results First Submitted: October 30, 2009
Results First Posted: May 11, 2012
Last Update Posted: May 11, 2012