Ankylosing Spondylitis
Conditions
Brief summary
Determine which remission criterion at Month 6 predicts remission at Month 12 the best.
Detailed description
The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 6 independent variables as ASAS partial remission, ASAS 5/6, ASAS60, ASAS40, BASDAI50 and ASDAS inactive disease status. This analysis will be conducted in each arm of the study as well as after a pooling of both patient groups. In this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop-out rate of 30% over 1 year period.
Interventions
DRUGetanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with AS who start treatment with Etanercept according to prevailing reimbursement criteria and dosing in line with SmPC. 1. First cohort: Etanercept is the first biological product prescribed 2. Second cohort: Etanercept is the second biological product prescribed 2. Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed. 3. 18 years of age or older at time of consent 4. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion criteria
1\. History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12 | Month 6 up to Month 12 | ASAS partial remission was defined as a score of less than or equal to (\<=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. |
| Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12 | Month 6 up to Month 12 | ASAS 5/6 was defined as at least greater than or equal to (\>=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion. |
| Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12 | Month 6 up to Month 12 | ASAS 60 was defined as at least \>= 60 percent relative improvement from baseline and an absolute change \>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm). |
| Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12 | Month 6 up to Month 12 | ASAS 40 was defined as at least \>= 40 percent relative improvement from baseline and an absolute change \>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm). |
| Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12 | Month 6 up to Month 12 | BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least \>=50 percent relative improvement from baseline in BASDAI total score. |
| Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12 | Month 6 up to Month 12 | ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity. |
| Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12 | Month 6 up to Month 12 | ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 | Baseline, Month 6 and 12 | Participants were asked to assess their disease activity on an 11-point scale of 0 (no disease activity) to 10 (extreme disease activity), where higher score indicated higher disease activity. |
| Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 | Baseline, Month 6 and 12 | Pain score is used to determine disease activity in participants with AS by measuring participants pain and swelling, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/swelling. The total pain score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of pain in participant due to AS. |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 | Baseline, Month 6 and 12 | BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. Each item was scored on a scale of 0=easy, to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. |
| Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 | Baseline, Month 6 and12 | Inflammation score is used to determine disease activity in participants with AS by measuring intensity and duration of inflammation, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of inflammation. The total inflammation score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of inflammation in participant due to AS. |
| Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 | Month 3, 6, 9 and 12 | ASAS partial remission was defined as a score of \<= 2 for each of the 4 items including pain, function, PGA and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. |
| Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 | Baseline, Month 6 and 12 | Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters. |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 | Baseline, Month 6 and 12 | BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. |
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 | Baseline, Month 6 and 12 | ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity. |
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 | Baseline, Month 6 and 12 | ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity. |
| Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 | Baseline, Month 6 and 12 | CRP is a protein marker in the blood for inflammation. |
| Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 | Month 3, 6, 9 and 12 | ASAS 5/6 was defined as at least \>= 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, CRP and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in mg/L and spinal mobility was measured in centimeter as calculated as the mean of right and left measurements of lateral spinal flexion. |
| Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 | Month 3, 6, 9 and 12 | ASAS 60 was defined as at least \>= 60 percent relative improvement from baseline and an absolute change \>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm). |
| Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 | Month 3, 6, 9 and 12 | ASAS 40 was defined as at least \>= 40 percent relative improvement from baseline and an absolute change \>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm). |
| Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 | Month 3, 6, 9 and 12 | BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least \>=50 percent relative improvement from baseline in BASDAI total score. |
| Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 | Month 3, 6, 9 and 12 | ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity. |
| Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 | Month 3, 6, 9 and 12 | ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept First Cohort Participants who had ankylosing spondylitis (AS) and commenced Etanercept as first biological product based on treating physician's discretion as per Summary of Product Characteristics (SmPC) and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 milligram (mg) twice weekly, 50 mg once weekly subcutaneous injection. | 70 |
| Etanercept Second Cohort Participants who had AS and commenced Etanercept as second biological product based on treating physician's discretion as per SmPC and prevailing reimbursement criteria in Belgium, were observed prospectively for 12 months. According to SmPC, recommended dose included Etanercept 25 mg twice weekly, 50 mg once weekly subcutaneous injection. | 14 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Enbrel treatment discontinued | 15 | 3 |
| Overall Study | Lost to Follow-up | 7 | 1 |
| Overall Study | Other | 2 | 2 |
Baseline characteristics
| Characteristic | Etanercept First Cohort | Etanercept Second Cohort | Total |
|---|---|---|---|
| Age, Continuous | 42.83 years STANDARD_DEVIATION 13.84 | 41.37 years STANDARD_DEVIATION 9.74 | 42.58 years STANDARD_DEVIATION 13.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 37 Participants | 9 Participants | 46 Participants |
| Sex: Female, Male Male | 33 Participants | 5 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 14 |
| other Total, other adverse events | 18 / 70 | 2 / 14 |
| serious Total, serious adverse events | 3 / 70 | 0 / 14 |
Outcome results
Primary
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12
ASAS 40 was defined as at least \>= 40 percent relative improvement from baseline and an absolute change \>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).
Time frame: Month 6 up to Month 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12 | 32.4 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12 | 20.0 percentage of participants |
Primary
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12
ASAS 5/6 was defined as at least greater than or equal to (\>=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion.
Time frame: Month 6 up to Month 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12 | 43.3 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12 | 60.0 percentage of participants |
Primary
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12
ASAS 60 was defined as at least \>= 60 percent relative improvement from baseline and an absolute change \>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).
Time frame: Month 6 up to Month 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12 | 29.4 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12 | 0.0 percentage of participants |
Primary
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12
ASAS partial remission was defined as a score of less than or equal to (\<=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.
Time frame: Month 6 up to Month 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12 | 14.7 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12 | 0.0 percentage of participants |
Primary
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12
ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
Time frame: Month 6 up to Month 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12 | 10.7 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12 | 0.0 percentage of participants |
Primary
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12
ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
Time frame: Month 6 up to Month 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12 | 15.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12 | 0.0 percentage of participants |
Primary
Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12
BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least \>=50 percent relative improvement from baseline in BASDAI total score.
Time frame: Month 6 up to Month 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12 | 27.8 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12 | 0.0 percentage of participants |
Secondary
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12
ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
Time frame: Baseline, Month 6 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept First Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 | Change at Month 12 | 1.70 Units on a scale | Standard Deviation 1.15 |
| Etanercept First Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 | Baseline | 3.73 Units on a scale | Standard Deviation 0.86 |
| Etanercept First Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 | Change at Month 6 | 1.44 Units on a scale | Standard Deviation 1.06 |
| Etanercept Second Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 | Baseline | 3.54 Units on a scale | Standard Deviation 0.87 |
| Etanercept Second Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 | Change at Month 6 | 1.54 Units on a scale | Standard Deviation 0.61 |
| Etanercept Second Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 | Change at Month 12 | 1.17 Units on a scale | Standard Deviation 1.01 |
Secondary
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12
ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
Time frame: Baseline, Month 6 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept First Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 | Change at Month 6 | 1.17 Units on a scale | Standard Deviation 0.65 |
| Etanercept First Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 | Baseline | 3.25 Units on a scale | Standard Deviation 0.75 |
| Etanercept First Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 | Change at Month 12 | 1.18 Units on a scale | Standard Deviation 0.87 |
| Etanercept Second Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 | Change at Month 6 | 1.11 Units on a scale | Standard Deviation 0.45 |
| Etanercept Second Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 | Change at Month 12 | 1.25 Units on a scale | Standard Deviation 0.94 |
| Etanercept Second Cohort | Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 | Baseline | 3.51 Units on a scale | Standard Deviation 0.69 |
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12
BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity.
Time frame: Baseline, Month 6 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept First Cohort | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 | Baseline | 6.45 Units on a scale | Standard Deviation 1.61 |
| Etanercept First Cohort | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 | Change at Month 6 | 2.16 Units on a scale | Standard Deviation 2.36 |
| Etanercept First Cohort | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 | Change at Month 12 | 2.62 Units on a scale | Standard Deviation 2.53 |
| Etanercept Second Cohort | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 | Baseline | 7.14 Units on a scale | Standard Deviation 0.9 |
| Etanercept Second Cohort | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 | Change at Month 6 | 2.16 Units on a scale | Standard Deviation 1.47 |
| Etanercept Second Cohort | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 | Change at Month 12 | 2.48 Units on a scale | Standard Deviation 2.05 |
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12
BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. Each item was scored on a scale of 0=easy, to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 to 10, where higher scores indicated more severe disease activity.
Time frame: Baseline, Month 6 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept First Cohort | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 | Change at Month 12 | 2.15 Units on a scale | Standard Deviation 2.65 |
| Etanercept First Cohort | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 | Baseline | 5.90 Units on a scale | Standard Deviation 2.35 |
| Etanercept First Cohort | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 | Change at Month 6 | 2.07 Units on a scale | Standard Deviation 2.5 |
| Etanercept Second Cohort | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 | Change at Month 6 | 1.90 Units on a scale | Standard Deviation 0.47 |
| Etanercept Second Cohort | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 | Change at Month 12 | 2.39 Units on a scale | Standard Deviation 2.28 |
| Etanercept Second Cohort | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 | Baseline | 7.34 Units on a scale | Standard Deviation 1.15 |
Secondary
Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12
CRP is a protein marker in the blood for inflammation.
Time frame: Baseline, Month 6 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept First Cohort | Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 | Baseline | 14.49 milligrams per liter | Standard Deviation 14.14 |
| Etanercept First Cohort | Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 | Change at Month 6 | 1.45 milligrams per liter | Standard Deviation 46.86 |
| Etanercept First Cohort | Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 | Change at Month 12 | 11.50 milligrams per liter | Standard Deviation 14.7 |
| Etanercept Second Cohort | Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 | Change at Month 12 | -2.03 milligrams per liter | Standard Deviation 9.47 |
| Etanercept Second Cohort | Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 | Baseline | 6.06 milligrams per liter | Standard Deviation 4.83 |
| Etanercept Second Cohort | Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 | Change at Month 6 | 5.04 milligrams per liter | Standard Deviation 1.28 |
Secondary
Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12
Inflammation score is used to determine disease activity in participants with AS by measuring intensity and duration of inflammation, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of inflammation. The total inflammation score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of inflammation in participant due to AS.
Time frame: Baseline, Month 6 and12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept First Cohort | Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 | Baseline | 5.98 Units on a scale | Standard Deviation 2.24 |
| Etanercept First Cohort | Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 | Change at Month 6 | 2.71 Units on a scale | Standard Deviation 2.34 |
| Etanercept First Cohort | Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 | Change at Month 12 | 3.07 Units on a scale | Standard Deviation 2.6 |
| Etanercept Second Cohort | Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 | Baseline | 6.81 Units on a scale | Standard Deviation 1.56 |
| Etanercept Second Cohort | Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 | Change at Month 6 | 3.40 Units on a scale | Standard Deviation 1.95 |
| Etanercept Second Cohort | Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 | Change at Month 12 | 2.50 Units on a scale | Standard Deviation 2.19 |
Secondary
Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12
Pain score is used to determine disease activity in participants with AS by measuring participants pain and swelling, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/swelling. The total pain score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of pain in participant due to AS.
Time frame: Baseline, Month 6 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept First Cohort | Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 | Baseline | 6.40 Units on a scale | Standard Deviation 2.05 |
| Etanercept First Cohort | Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 | Change at Month 6 | 2.15 Units on a scale | Standard Deviation 2.61 |
| Etanercept First Cohort | Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 | Change at Month 12 | 2.60 Units on a scale | Standard Deviation 2.96 |
| Etanercept Second Cohort | Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 | Baseline | 7.00 Units on a scale | Standard Deviation 1.39 |
| Etanercept Second Cohort | Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 | Change at Month 6 | 1.70 Units on a scale | Standard Deviation 1.57 |
| Etanercept Second Cohort | Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 | Change at Month 12 | 2.81 Units on a scale | Standard Deviation 2.17 |
Secondary
Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12
Participants were asked to assess their disease activity on an 11-point scale of 0 (no disease activity) to 10 (extreme disease activity), where higher score indicated higher disease activity.
Time frame: Baseline, Month 6 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept First Cohort | Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 | Baseline | 7.61 Units on a scale | Standard Deviation 1.78 |
| Etanercept First Cohort | Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 | Change at Month 6 | 3.62 Units on a scale | Standard Deviation 2.81 |
| Etanercept First Cohort | Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 | Change at Month 12 | 3.43 Units on a scale | Standard Deviation 2.96 |
| Etanercept Second Cohort | Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 | Baseline | 7.63 Units on a scale | Standard Deviation 0.92 |
| Etanercept Second Cohort | Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 | Change at Month 6 | 2.60 Units on a scale | Standard Deviation 2.3 |
| Etanercept Second Cohort | Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 | Change at Month 12 | 3.00 Units on a scale | Standard Deviation 2 |
Secondary
Change From Baseline in Spinal Mobility Measurement at Month 6 and 12
Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters.
Time frame: Baseline, Month 6 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept First Cohort | Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 | Change at Month 6 | -3.13 centimeters | Standard Deviation 3.41 |
| Etanercept First Cohort | Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 | Baseline | 10.04 centimeters | Standard Deviation 4.87 |
| Etanercept First Cohort | Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 | Change at Month 12 | -3.73 centimeters | Standard Deviation 5.3 |
| Etanercept Second Cohort | Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 | Baseline | 10.80 centimeters | Standard Deviation 4.51 |
| Etanercept Second Cohort | Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 | Change at Month 6 | -0.83 centimeters | Standard Deviation 3.82 |
| Etanercept Second Cohort | Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 | Change at Month 12 | 1.08 centimeters | Standard Deviation 4.68 |
Secondary
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12
ASAS 40 was defined as at least \>= 40 percent relative improvement from baseline and an absolute change \>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).
Time frame: Month 3, 6, 9 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 37.5 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 41.2 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 46.7 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 46.3 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 42.9 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 28.6 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 16.7 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 20.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12
ASAS 5/6 was defined as at least \>= 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, CRP and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in mg/L and spinal mobility was measured in centimeter as calculated as the mean of right and left measurements of lateral spinal flexion.
Time frame: Month 3, 6, 9 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 51.4 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 57.7 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 46.7 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 61.5 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 60.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 20.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 60.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 33.3 percentage of participants |
Secondary
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12
ASAS 60 was defined as at least \>= 60 percent relative improvement from baseline and an absolute change \>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).
Time frame: Month 3, 6, 9 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 30.0 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 33.3 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 32.4 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 29.3 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 0.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 14.3 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 0.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12
ASAS partial remission was defined as a score of \<= 2 for each of the 4 items including pain, function, PGA and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.
Time frame: Month 3, 6, 9 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 12.5 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 17.7 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 16.7 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 21.4 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 14.3 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 0.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 0.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12
ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
Time frame: Month 3, 6, 9 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 30.8 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 17.9 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 24.2 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 26.1 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 0.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 0.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 0.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12
ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
Time frame: Month 3, 6, 9 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 16.0 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 15.4 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 20.0 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 19.4 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 0.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 0.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 20.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12
BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least \>=50 percent relative improvement from baseline in BASDAI total score.
Time frame: Month 3, 6, 9 and 12
Population: Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept First Cohort | Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 41.5 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 30.6 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 45.2 percentage of participants |
| Etanercept First Cohort | Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 42.2 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 | Month 12 | 25.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 | Month 3 | 14.3 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 | Month 9 | 0.0 percentage of participants |
| Etanercept Second Cohort | Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 | Month 6 | 0.0 percentage of participants |