Axial Spondyloarthritis
Conditions
Keywords
Etanercept, Axial Spondyloarthritis, NSAIDs sparing effect
Brief summary
This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.
Interventions
DRUGetanercept
etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
DRUGplacebo
placebo subcutaneous (SC) injections once weekly for 8 weeks.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female subjects aged 18 years and over at the time of consent to the study. * Diagnosis of SpA, as defined by the ASAS criteria for axial SpA * Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of \> 1 month (for both NSAIDs combined) before the Screening visit. * Active axial involvement defined by mini BASDAI
Exclusion criteria
* Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. * Subjects who have received any previous treatment with etanercept or other TNFα inhibitors or biologic agents. * Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8. | Week 8 | Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken. Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4. | Week 4 | A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10. |
| Change From Baseline in BASDAI at Week 8 | Week 8 | A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10. |
| Change From Baseline in BASDAI Score at Weeks 12 and 16. | Week 12 and 16 | A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10. |
| Number of Participants Using NSAIDs at Week 8. | Week 8 | Participants who received NSAIDs at Week 8 were reported. |
| Change From Baseline in Mini BASDAI at Week 8 (AUC). | Week 8 | A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10. |
| Number of Participants Achieved BASDAI 50 at Week 8. | Week 8 | Response was defined as a 50% improvement of the baseline BASDAI after 8 Weeks. |
| Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16. | Weeks 4, 12 and 16 | Response was defined as a 50% improvement of the baseline BASDAI after 4, 12 and 16 Weeks. |
| Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16 | Weeks 4, 12 and 16 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. |
| Number of Participants Achieving ASAS 20 at Week 8 | Week 8 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. |
| Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16. | Weeks 4, 12 and 16 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. |
| Number of Participants Achieving ASAS 40 at Week 8 | Week 8 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. |
| Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8. | Week 8 | The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule. LOCF will only be applied where the subject is still in the study and the NSAID score is missing. |
| Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16. | Weeks 4, 12 and 16 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. |
| Number of Participants Achieving ASAS 70 at Week 8 | Week 8 | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) |
| Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4. | Week 4 | The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12\*Total Back Pain+0.06\*Duration of Morning Stiffness+0.11\*Patient Global+0.07\*Peripheral Pain/Swelling+0.58\*ln(CRP+1). |
| Change From Baseline in ASDAS CRP Score at Week 8. | Week 8 | The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12\*Total Back Pain+0.06\*Duration of Morning Stiffness+0.11\*Patient Global+0.07\*Peripheral Pain/Swelling+0.58\*ln(CRP+1). |
| Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4. | Week 4 | The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08\*Total Back Pain+0.07\*Duration of Morning Stiffness+0.11\*Patient Global+0.09\*Peripheral Pain/Swelling+0.29\*√(ESR). |
| Change From Baseline in ASDAS ESR Score at Week 8. | Week 8 | The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08\*Total Back Pain+0.07\*Duration of Morning Stiffness+0.11\*Patient Global+0.09\*Peripheral Pain/Swelling+0.29\*√(ESR). |
| Change From Baseline in ASDAS ESR Score at Weeks 12 and 16. | Weeks 12 and 16 | The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08\*Total Back Pain+0.07\*Duration of Morning Stiffness+0.11\*Patient Global+0.09\*Peripheral Pain/Swelling+0.29\*√(ESR). |
| Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only) | Week 16 | Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken. Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption. |
| Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only) | Week 16 | Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken. Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption. |
| Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8 | Week 8 | Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity. |
| Change From Baseline in ASDAS CRP Score at Weeks 12 and 16. | Weeks 12 and 16 | The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12\*Total Back Pain+0.06\*Duration of Morning Stiffness+0.11\*Patient Global+0.07\*Peripheral Pain/Swelling+0.58\*ln(CRP+1). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With MCII at Weeks 4, 12 and 16 | Weeks 4, 12 and 16 | MCII was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement. |
| Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 | Weeks 4, 8, 12 and 16 | MCID was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCID was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCID was evaluated based on participant's opinion on the following three items for the question of how have they been during the last 48 hours compared to Screening visit: 'improved-less pain', 'no change', and 'worse-more pain'. Participants were further asked the importance of worsening i.e., very important, moderately important, slightly important and not at all important as MCID evaluation criteria. |
| Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8 | Week 8 | PASS is defined as a symptom state that the participants consider acceptable. PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months. |
| Number of Participants With PASS at Weeks 4, 12 and 16 | Weeks 4, 12 and 16 | PASS is defined as a symptom state that the participants consider acceptable. The PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months. |
| Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4 | Week 4 | BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. |
| Change From Baseline in BASMI at Week 8 | Week 8 | BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. |
| Change From Baseline in BASMI at Weeks 12 and 16 | Weeks 12 and 16 | BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. |
| Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4 | Week 4 | BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter. |
| Change From Baseline in BASMI Components at Week 8 | Week 8 | BASMI is an objective measure of spinal mobility. The BASMI score was 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. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken. |
| Change From Baseline in BASMI Components at Week 12 | Week 12 | BASMI is an objective measure of spinal mobility. The BASMI score was 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. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken. |
| Change From Baseline in BASMI Components at Week 16 | Week 16 | BASMI is an objective measure of spinal mobility. The BASMI score was 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. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken. |
| Change From Baseline in Chest Expansion at Week 4 | Week 4 | Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values. |
| Change From Baseline in Chest Expansion at Week 8 | Week 8 | Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values. |
| Change From Baseline in Chest Expansion at Weeks 12 and 16 | Weeks 12 and 16 | Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values. |
| Change From Baseline in BASMI Components at Week 4 | Week 4 | BASMI is an objective measure of spinal mobility. The BASMI score was 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. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken. |
| Change From Baseline in BAS-G Score at Week 8 | Week 8 | BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter. |
| Change From Baseline in BAS-G Score at Weeks 12 and 16. | Weeks 12 and 16 | BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter. |
| Change From Baseline in Total Back Pain at Week 4 | Week 4 | Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain). |
| Change From Baseline in Total Back Pain at Week 8 | Week 8 | Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain). |
| Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 | Weeks 4, 8, 12 and 16 | Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain). |
| Change From Baseline in Nocturnal Back Pain at Week 4 | Week 4 | Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain). |
| Change From Baseline in Nocturnal Back Pain at Week 8 | Week 8 | Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain). |
| Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16 | Weeks 12 and 16 | Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain). |
| Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4 | Week 4 | Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions. |
| Change From Baseline in BASFI at Week 8 | Week 8 | Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions. |
| Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4 | Week 4 | Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity. |
| Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16 | Weeks 12 and 16 | Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity. |
| Change From Baseline in PGA (Physician Global Assessment) at Week 4 | Week 4 | The investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity). |
| Change From Baseline in PGA (Physician Global Assessment) at Week 8 | Week 8 | Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity). |
| Change From Baseline in PGA at Weeks 12 and 16 | Weeks 12 and 16 | Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity). |
| Change From Baseline in Each BASFI Component at Week 4 | Week 4 | BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions. |
| Change From Baseline in Each BASFI Component at Week 8 | Week 8 | BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions. |
| Change From Baseline in Each BASFI Component at Week 12 | Week 12 | BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions. |
| Change From Baseline in Each BASFI Component at Week 16 | Week 16 | BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions. |
| Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 | Weeks 4, 8, 12 and 16 | Swollen joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation. |
| Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 | Weeks 4, 8, 12 and 16 | Tender joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation. |
| Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 | Weeks 4, 8, 12 and 16 | Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness). |
| Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8 | Week 8 | MCII was completed at visit weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain'. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement. |
Countries
France
Participant flow
Recruitment details
Out of 128 screened participants, 90 were assigned to either double-blind etanercept (ETN) 50 mg to open-label ETN 50 mg or placebo to open-label ETN 50 mg group. Participants entered an escape arm at Week 4 visit if the total back pain or the BASDAI score increased \>50% vs baseline or participants were with maximum tolerated NSAIDs.
Pre-assignment details
Four participants who were randomized to receive placebo in the double-blind phase were withdrawn during this phase, and they did not enter the escape arm, so these four participants never received ETN.
Participants by arm
| Arm | Count |
|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks | 42 |
| Placebo to Open Label ETN 50 mg Group Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks | 48 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Does not meet entrance criteria | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Placebo to Open Label ETN 50 mg Group | Total |
|---|---|---|---|
| Age, Customized 18 - 44 Years | 31 Participants | 32 Participants | 63 Participants |
| Age, Customized 45 - 64 Years | 9 Participants | 15 Participants | 24 Participants |
| Age, Customized ≥ 65 Years | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Male | 24 Participants | 32 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 42 | 34 / 48 |
| serious Total, serious adverse events | 1 / 42 | 2 / 48 |
Outcome results
Primary
Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.
Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken. Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption.
Time frame: Week 8
Population: The Intent To Treat (ITT) population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8. | -63.90 Scores on a scale | Standard Error 6.09 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8. | -36.63 Scores on a scale | Standard Error 5.87 |
Comparison: The primary analysis of the primary endpoint was an Analysis of covariance (ANCOVA)with Baseline NSAID score and treatment as explanatory variables. The hypothesis tested for the primary endpoint was as follows: H0: ΔETN = ΔPlacebo; H1: ΔETN ≠ ΔPlacebo.p-value: 0.001995% CI: [-44.17, -10.38]ANCOVA
Secondary
Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.
The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12\*Total Back Pain+0.06\*Duration of Morning Stiffness+0.11\*Patient Global+0.07\*Peripheral Pain/Swelling+0.58\*ln(CRP+1).
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4. | -0.94 Units on a scale | Standard Error 0.12 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4. | -0.16 Units on a scale | Standard Error 0.11 |
Comparison: ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.p-value: <0.000195% CI: [-1.11, -0.44]ANCOVA
Secondary
Change From Baseline in ASDAS CRP Score at Week 8.
The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12\*Total Back Pain+0.06\*Duration of Morning Stiffness+0.11\*Patient Global+0.07\*Peripheral Pain/Swelling+0.58\*ln(CRP+1).
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in ASDAS CRP Score at Week 8. | -1.21 Units on a scale | Standard Error 0.14 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in ASDAS CRP Score at Week 8. | -0.53 Units on a scale | Standard Error 0.14 |
Comparison: ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.p-value: 0.001195% CI: [-1.09, -0.28]ANCOVA
Secondary
Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.
The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12\*Total Back Pain+0.06\*Duration of Morning Stiffness+0.11\*Patient Global+0.07\*Peripheral Pain/Swelling+0.58\*ln(CRP+1).
Time frame: Weeks 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in ASDAS CRP Score at Weeks 12 and 16. | Week 12 (N = 35, 36) | -1.4 Units on scale | Standard Deviation 1.13 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in ASDAS CRP Score at Weeks 12 and 16. | Week 16 (N = 28, 33) | -1.6 Units on scale | Standard Deviation 0.92 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in ASDAS CRP Score at Weeks 12 and 16. | Week 12 (N = 35, 36) | -1.2 Units on scale | Standard Deviation 1.07 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in ASDAS CRP Score at Weeks 12 and 16. | Week 16 (N = 28, 33) | -1.5 Units on scale | Standard Deviation 1.02 |
Secondary
Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.
The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08\*Total Back Pain+0.07\*Duration of Morning Stiffness+0.11\*Patient Global+0.09\*Peripheral Pain/Swelling+0.29\*√(ESR).
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4. | -0.76 Units on a scale | Standard Error 0.12 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4. | -0.19 Units on a scale | Standard Error 0.11 |
Comparison: ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.p-value: 0.001195% CI: [-0.9, -0.24]ANCOVA
Secondary
Change From Baseline in ASDAS ESR Score at Week 8.
The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08\*Total Back Pain+0.07\*Duration of Morning Stiffness+0.11\*Patient Global+0.09\*Peripheral Pain/Swelling+0.29\*√(ESR).
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in ASDAS ESR Score at Week 8. | -1.05 Units on a scale | Standard Error 0.16 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in ASDAS ESR Score at Week 8. | -0.38 Units on a scale | Standard Error 0.15 |
Comparison: ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.p-value: 0.003795% CI: [-1.11, -0.22]ANCOVA
Secondary
Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.
The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08\*Total Back Pain+0.07\*Duration of Morning Stiffness+0.11\*Patient Global+0.09\*Peripheral Pain/Swelling+0.29\*√(ESR).
Time frame: Weeks 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in ASDAS ESR Score at Weeks 12 and 16. | Week 12 (N = 25, 32) | -1.0 Units on a scale | Standard Deviation 1.1 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in ASDAS ESR Score at Weeks 12 and 16. | Week 16 (N = 23, 26) | -1.3 Units on a scale | Standard Deviation 0.79 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in ASDAS ESR Score at Weeks 12 and 16. | Week 12 (N = 25, 32) | -1.0 Units on a scale | Standard Deviation 1.01 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in ASDAS ESR Score at Weeks 12 and 16. | Week 16 (N = 23, 26) | -1.3 Units on a scale | Standard Deviation 1.21 |
Secondary
Change From Baseline in BASDAI at Week 8
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASDAI at Week 8 | -2.01 Units on a scale | Standard Error 0.32 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASDAI at Week 8 | -1.13 Units on a scale | Standard Error 0.31 |
Comparison: The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 8.p-value: 0.05195% CI: [-1.76, 0]ANCOVA
Secondary
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8
Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8 | -2.74 Units on a scale | Standard Error 0.39 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8 | -1.59 Units on a scale | Standard Error 0.37 |
Comparison: ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.p-value: 0.034495% CI: [-2.22, -0.09]ANCOVA
Secondary
Change From Baseline in BASDAI Score at Weeks 12 and 16.
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Time frame: Week 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Score at Weeks 12 and 16. | Week 12 (N=36, N=41) | -2.5 Units on a scale | Standard Deviation 2.35 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Score at Weeks 12 and 16. | Week 16 (N=28, N=37) | -2.6 Units on a scale | Standard Deviation 1.83 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Score at Weeks 12 and 16. | Week 12 (N=36, N=41) | -2.6 Units on a scale | Standard Deviation 2.12 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Score at Weeks 12 and 16. | Week 16 (N=28, N=37) | -3.0 Units on a scale | Standard Deviation 2.14 |
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4. | -1.50 Units on a scale | Standard Error 0.27 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4. | -0.56 Units on a scale | Standard Error 0.26 |
Comparison: The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 4.p-value: 0.015395% CI: [-1.68, -0.18]ANCOVA
Secondary
Change From Baseline in Mini BASDAI at Week 8 (AUC).
A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. The efficacy analysis was based on the ITT population. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Mini BASDAI at Week 8 (AUC). | 275.68 Unit on a scale * days | Standard Error 13.64 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Mini BASDAI at Week 8 (AUC). | 329.37 Unit on a scale * days | Standard Error 12.88 |
Comparison: The changes from baseline in the continuous endpoints of mini BASDAI was analyzed using ANCOVA. The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule.p-value: 0.005395% CI: [-91.01, -16.38]ANCOVA
Secondary
Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)
Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken. Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption.
Time frame: Week 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only) | -65.93 Scores on a scale | Standard Error 10.19 |
Secondary
Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)
Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken. Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption.
Time frame: Week 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only) | -39.22 Scores on a scale | Standard Error 6.44 |
Secondary
Number of Participants Achieved BASDAI 50 at Week 8.
Response was defined as a 50% improvement of the baseline BASDAI after 8 Weeks.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieved BASDAI 50 at Week 8. | 16 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieved BASDAI 50 at Week 8. | 8 Participants |
Comparison: Logistic regression with baseline morning stiffness score and treatment group included as covariates.p-value: 0.032495% CI: [1.1, 8.01]Regression, Logistic
Secondary
Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.
Response was defined as a 50% improvement of the baseline BASDAI after 4, 12 and 16 Weeks.
Time frame: Weeks 4, 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16. | Week 4 (N=39, N=44) | 10 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16. | Week 12 (N=36, N=41) | 17 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16. | Week 16 (N=28, N=37) | 15 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16. | Week 4 (N=39, N=44) | 3 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16. | Week 12 (N=36, N=41) | 19 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16. | Week 16 (N=28, N=37) | 18 Participants |
Secondary
Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time frame: Weeks 4, 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16 | Week 4 (N = 38, 42) | 14 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16 | Week 12 (N = 35, 37) | 17 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16 | Week 16 (N = 28, 36) | 18 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16 | Week 4 (N = 38, 42) | 5 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16 | Week 12 (N = 35, 37) | 21 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16 | Week 16 (N = 28, 36) | 23 Participants |
Secondary
Number of Participants Achieving ASAS 20 at Week 8
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 20 at Week 8 | 16 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 20 at Week 8 | 10 Participants |
Comparison: Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.p-value: 0.050195% CI: [1, 7.27]Regression, Logistic
Secondary
Number of Participants Achieving ASAS 40 at Week 8
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 40 at Week 8 | 16 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 40 at Week 8 | 9 Participants |
Comparison: Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.p-value: 0.028495% CI: [1.13, 8.54]Regression, Logistic
Secondary
Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time frame: Weeks 4, 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16. | Week 4 (N = 38, 42) | 9 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16. | Week 12 (N = 35, 37) | 17 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16. | Week 16 (N = 28, 36) | 16 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16. | Week 4 (N = 38, 42) | 3 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16. | Week 12 (N = 35, 37) | 20 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16. | Week 16 (N = 28, 36) | 20 Participants |
Secondary
Number of Participants Achieving ASAS 70 at Week 8
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity)
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 70 at Week 8 | 5 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 70 at Week 8 | 3 Participants |
Comparison: Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.p-value: 0.329195% CI: [0.47, 9.72]Regression, Logistic
Secondary
Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time frame: Weeks 4, 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16. | Week 4 (N = 38, 42) | 2 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16. | Week 12 (N = 35, 37) | 8 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16. | Week 16 (N = 28, 36) | 5 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16. | Week 4 (N = 38, 42) | 1 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16. | Week 12 (N = 35, 37) | 7 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16. | Week 16 (N = 28, 36) | 11 Participants |
Secondary
Number of Participants Using NSAIDs at Week 8.
Participants who received NSAIDs at Week 8 were reported.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants Using NSAIDs at Week 8. | 17 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants Using NSAIDs at Week 8. | 32 Participants |
Comparison: Logistic regression with baseline score and treatment group included as covariates.p-value: 0.006695% CI: [0.07, 0.65]Regression, Logistic
Secondary
Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.
The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule. LOCF will only be applied where the subject is still in the study and the NSAID score is missing.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8. | 45.24 Unit on a scale * days | Standard Error 5.44 |
| Placebo to Open Label ETN 50 mg Group | Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8. | 65.02 Unit on a scale * days | Standard Error 5.3 |
Comparison: The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model and using the repeated measures for the changes from Baseline in each outcome at Week 8.p-value: 0.011595% CI: [-34.99, -4.57]ANCOVA
Other Pre-specified
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4
Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4 | -2.23 Units on a scale | Standard Error 0.34 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4 | -1.07 Units on a scale | Standard Error 0.32 |
Comparison: ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.p-value: 0.015295% CI: [-2.09, -0.23]ANCOVA
Other Pre-specified
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16
Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.
Time frame: Weeks 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16 | Week 12 (N = 36, 42) | -3.4 Units on a scale | Standard Deviation 2.75 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16 | Weel 16 (N = 28, 37) | -3.3 Units on a scale | Standard Deviation 2.64 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16 | Week 12 (N = 36, 42) | -3.0 Units on a scale | Standard Deviation 2.74 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16 | Weel 16 (N = 28, 37) | -3.9 Units on a scale | Standard Deviation 2.46 |
Other Pre-specified
Change From Baseline in BASFI at Week 8
Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASFI at Week 8 | -1.68 Units on a scale | Standard Error 0.3 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASFI at Week 8 | -0.77 Units on a scale | Standard Error 0.29 |
Comparison: ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.p-value: 0.029795% CI: [-1.74, -0.09]ANCOVA
Other Pre-specified
Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4
Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4 | -1.13 Units on a scale | Standard Error 0.25 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4 | -0.32 Units on a scale | Standard Error 0.24 |
Comparison: ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.p-value: 0.023795% CI: [-1.5, -0.11]ANCOVA
Other Pre-specified
Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4
BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4 | -1.51 Units on a scale | Standard Error 0.33 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4 | -0.21 Units on a scale | Standard Error 0.31 |
Comparison: ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.p-value: 0.00595% CI: [-2.2, -0.4]ANCOVA
Other Pre-specified
Change From Baseline in BAS-G Score at Week 8
BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BAS-G Score at Week 8 | -2.29 Units on a scale | Standard Error 0.4 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BAS-G Score at Week 8 | -1.05 Units on a scale | Standard Error 0.38 |
Comparison: ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.p-value: 0.025695% CI: [-2.33, -0.16]ANCOVA
Other Pre-specified
Change From Baseline in BAS-G Score at Weeks 12 and 16.
BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.
Time frame: Weeks 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BAS-G Score at Weeks 12 and 16. | Week 12 (N = 36, 41) | -2.8 Units on a scale | Standard Deviation 2.5 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BAS-G Score at Weeks 12 and 16. | Week 16 (N = 28, 36) | -2.6 Units on a scale | Standard Deviation 2.08 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BAS-G Score at Weeks 12 and 16. | Week 12 (N = 36, 41) | -2.4 Units on a scale | Standard Deviation 2.72 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BAS-G Score at Weeks 12 and 16. | Week 16 (N = 28, 36) | -2.6 Units on a scale | Standard Deviation 3.12 |
Other Pre-specified
Change From Baseline in BASMI at Week 8
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI at Week 8 | -0.40 Units on a scale | Standard Error 0.21 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI at Week 8 | -0.11 Units on a scale | Standard Error 0.19 |
Comparison: ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factorp-value: 0.296795% CI: [-0.86, 0.27]ANCOVA
Other Pre-specified
Change From Baseline in BASMI at Weeks 12 and 16
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Time frame: Weeks 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI at Weeks 12 and 16 | Week 12 (N = 35, 43) | -0.4 Units on a scale | Standard Deviation 1.44 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI at Weeks 12 and 16 | Week 16 (N = 28, 38) | -0.6 Units on a scale | Standard Deviation 1.71 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI at Weeks 12 and 16 | Week 12 (N = 35, 43) | -0.4 Units on a scale | Standard Deviation 1.26 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI at Weeks 12 and 16 | Week 16 (N = 28, 38) | -0.6 Units on a scale | Standard Deviation 1.23 |
Other Pre-specified
Change From Baseline in BASMI Components at Week 12
BASMI is an objective measure of spinal mobility. The BASMI score was 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. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.
Time frame: Week 12
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 12 | Tragus to wall distance (N = 36, 42) | 0.2 Units on a scale | Standard Deviation 0.51 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 12 | Modified schober's test (N = 36, 43) | -0.1 Units on a scale | Standard Deviation 0.55 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 12 | Lateral flexion (N = 36, 42) | -0.2 Units on a scale | Standard Deviation 0.56 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 12 | Intermalleolar distance (N = 33, 42) | -0.2 Units on a scale | Standard Deviation 0.88 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 12 | Cervical rotation (N= 35, 43) | -0.1 Units on a scale | Standard Deviation 0.66 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 12 | Intermalleolar distance (N = 33, 42) | -0.1 Units on a scale | Standard Deviation 0.77 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 12 | Cervical rotation (N= 35, 43) | -0.1 Units on a scale | Standard Deviation 0.4 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 12 | Tragus to wall distance (N = 36, 42) | 0.0 Units on a scale | Standard Deviation 0.41 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 12 | Lateral flexion (N = 36, 42) | -0.2 Units on a scale | Standard Deviation 0.4 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 12 | Modified schober's test (N = 36, 43) | 0.0 Units on a scale | Standard Deviation 0.77 |
Other Pre-specified
Change From Baseline in BASMI Components at Week 16
BASMI is an objective measure of spinal mobility. The BASMI score was 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. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.
Time frame: Week 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 16 | Tragus to wall distance (N = 29, 37) | 0.0 Units on a scale | Standard Deviation 0.33 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 16 | Modified schober's test (N = 29, 38) | -0.1 Units on a scale | Standard Deviation 0.49 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 16 | Lateral flexion (N= 29, 36) | -0.1 Units on a scale | Standard Deviation 0.64 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 16 | Intermalleolar distance (N = 26, 37) | -0.3 Units on a scale | Standard Deviation 0.87 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 16 | Cervical rotation (N = 28, 38) | -0.1 Units on a scale | Standard Deviation 0.54 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 16 | Intermalleolar distance (N = 26, 37) | -0.2 Units on a scale | Standard Deviation 0.66 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 16 | Cervical rotation (N = 28, 38) | -0.1 Units on a scale | Standard Deviation 0.56 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 16 | Tragus to wall distance (N = 29, 37) | -0.1 Units on a scale | Standard Deviation 0.47 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 16 | Lateral flexion (N= 29, 36) | -0.2 Units on a scale | Standard Deviation 0.47 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 16 | Modified schober's test (N = 29, 38) | 0.0 Units on a scale | Standard Deviation 0.77 |
Other Pre-specified
Change From Baseline in BASMI Components at Week 4
BASMI is an objective measure of spinal mobility. The BASMI score was 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. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 4 | Tragus to wall distance (N=41, 43) | 0.0 Units on a scale | Standard Deviation 0.31 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 4 | Modified schober's test (N = 41, 45) | 0.0 Units on a scale | Standard Deviation 0.55 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 4 | Lateral flexion (N = 40, 42) | -0.1 Units on a scale | Standard Deviation 0.61 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 4 | Intermalleolar distance (N = 38, 44) | -0.2 Units on a scale | Standard Deviation 0.73 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 4 | Cervical rotation (N = 39, 45) | 0.0 Units on a scale | Standard Deviation 0.46 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 4 | Intermalleolar distance (N = 38, 44) | 0.1 Units on a scale | Standard Deviation 0.66 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 4 | Cervical rotation (N = 39, 45) | 0.0 Units on a scale | Standard Deviation 0.34 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 4 | Tragus to wall distance (N=41, 43) | 0.0 Units on a scale | Standard Deviation 0.49 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 4 | Lateral flexion (N = 40, 42) | -0.1 Units on a scale | Standard Deviation 0.5 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 4 | Modified schober's test (N = 41, 45) | 0.1 Units on a scale | Standard Deviation 0.68 |
Other Pre-specified
Change From Baseline in BASMI Components at Week 8
BASMI is an objective measure of spinal mobility. The BASMI score was 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. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 8 | Tragus to wall distance (N = 38, 43) | 0.1 Units on a scale | Standard Deviation 0.4 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 8 | Modified schober's test (N = 38, 44) | -0.1 Units on a scale | Standard Deviation 0.54 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 8 | Lateral flexion (N = 38, 42) | -0.1 Units on a scale | Standard Deviation 0.58 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 8 | Intermalleolar distance (N = 36, 43) | -0.2 Units on a scale | Standard Deviation 0.75 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 8 | Cervical rotation (N = 37, 44) | -0.1 Units on a scale | Standard Deviation 0.6 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 8 | Intermalleolar distance (N = 36, 43) | 0.0 Units on a scale | Standard Deviation 0.76 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 8 | Cervical rotation (N = 37, 44) | 0.0 Units on a scale | Standard Deviation 0.53 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 8 | Tragus to wall distance (N = 38, 43) | -0.1 Units on a scale | Standard Deviation 0.43 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 8 | Lateral flexion (N = 38, 42) | -0.1 Units on a scale | Standard Deviation 0.55 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in BASMI Components at Week 8 | Modified schober's test (N = 38, 44) | 0.1 Units on a scale | Standard Deviation 0.67 |
Other Pre-specified
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4 | -0.31 Units on a scale | Standard Error 0.19 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4 | 0.05 Units on a scale | Standard Error 0.17 |
Comparison: ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factorp-value: 0.160195% CI: [-0.87, 0.15]ANCOVA
Other Pre-specified
Change From Baseline in Chest Expansion at Week 4
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Chest Expansion at Week 4 | 2.61 cm | Standard Error 1.61 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Chest Expansion at Week 4 | 0.21 cm | Standard Error 1.48 |
Comparison: ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.p-value: 0.273595% CI: [-1.94, 6.75]ANCOVA
Other Pre-specified
Change From Baseline in Chest Expansion at Week 8
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Chest Expansion at Week 8 | 0.62 cm | Standard Error 0.24 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Chest Expansion at Week 8 | -0.06 cm | Standard Error 0.23 |
Comparison: ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.p-value: 0.042295% CI: [0.02, 1.34]ANCOVA
Other Pre-specified
Change From Baseline in Chest Expansion at Weeks 12 and 16
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.
Time frame: Weeks 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Chest Expansion at Weeks 12 and 16 | Week 12 (N = 34, 42) | 0.3 cm | Standard Deviation 2.26 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Chest Expansion at Weeks 12 and 16 | Week 16 (N = 27, 37) | 0.2 cm | Standard Deviation 1.42 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Chest Expansion at Weeks 12 and 16 | Week 12 (N = 34, 42) | 0.1 cm | Standard Deviation 2.03 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Chest Expansion at Weeks 12 and 16 | Week 16 (N = 27, 37) | 2.0 cm | Standard Deviation 10.92 |
Other Pre-specified
Change From Baseline in Each BASFI Component at Week 12
BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.
Time frame: Week 12
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Putting on socks (n = 36, 42) | -1.6 Units on a scale | Standard Deviation 2.75 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Bending forward (N = 36, 42) | -2.2 Units on a scale | Standard Deviation 3.25 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Reaching up high (N = 36,42) | -1.7 Units on a scale | Standard Deviation 3.21 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Getting out of an armless chair (N = 36, 42) | -2.6 Units on a scale | Standard Deviation 3.38 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Getting up off floor from back (N = 36, 42) | -2.5 Units on a scale | Standard Deviation 3.09 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | standing unsupported 10 min (N = 36,42) | -2.0 Units on a scale | Standard Deviation 2.49 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Climbing steps without aid (N = 36, 42) | -1.6 Units on a scale | Standard Deviation 3.18 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Looking over shoulder (N = 36, 42) | -2.6 Units on a scale | Standard Deviation 2.92 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Physically demanding activities (N = 36, 41) | -2.2 Units on a scale | Standard Deviation 2.68 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Full day's activities (N = 36, 40) | -1.8 Units on a scale | Standard Deviation 2.45 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Looking over shoulder (N = 36, 42) | -1.8 Units on a scale | Standard Deviation 2.62 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Putting on socks (n = 36, 42) | -1.6 Units on a scale | Standard Deviation 2.39 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | standing unsupported 10 min (N = 36,42) | -2.1 Units on a scale | Standard Deviation 2.95 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Bending forward (N = 36, 42) | -1.7 Units on a scale | Standard Deviation 2.56 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Full day's activities (N = 36, 40) | -2.3 Units on a scale | Standard Deviation 2.12 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Reaching up high (N = 36,42) | -1.5 Units on a scale | Standard Deviation 2.35 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Climbing steps without aid (N = 36, 42) | -1.4 Units on a scale | Standard Deviation 2.43 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Getting out of an armless chair (N = 36, 42) | -2.0 Units on a scale | Standard Deviation 2.5 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Physically demanding activities (N = 36, 41) | -2.3 Units on a scale | Standard Deviation 2.29 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 12 | Getting up off floor from back (N = 36, 42) | -1.7 Units on a scale | Standard Deviation 2.66 |
Other Pre-specified
Change From Baseline in Each BASFI Component at Week 16
BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.
Time frame: Week 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Putting on socks (N = 28, 37) | -1.1 Units on a scale | Standard Deviation 3.18 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Bending forward (N = 28, 37) | -2.0 Units on a scale | Standard Deviation 3.36 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Reaching up high (N = 27, 37) | -1.0 Units on a scale | Standard Deviation 3.55 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Getting out of an armless chair (N = 28, 37) | -2.0 Units on a scale | Standard Deviation 3.42 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Getting up off floor from back (N = 28, 37) | -2.2 Units on a scale | Standard Deviation 2.83 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Standing unsupported 10 min (N = 28, 37) | -2.2 Units on a scale | Standard Deviation 2.5 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Climbing steps without aid (N = 28, 37) | -1.3 Units on a scale | Standard Deviation 3.13 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Looking over shoulder (N = 28, 37) | -2.4 Units on a scale | Standard Deviation 3.19 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Physically demanding activities (N = 28, 36) | -2.3 Units on a scale | Standard Deviation 2.46 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Full day's activities (N = 28, 36) | -1.9 Units on a scale | Standard Deviation 2.28 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Looking over shoulder (N = 28, 37) | -2.3 Units on a scale | Standard Deviation 2.62 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Putting on socks (N = 28, 37) | -2.1 Units on a scale | Standard Deviation 2.4 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Standing unsupported 10 min (N = 28, 37) | -2.6 Units on a scale | Standard Deviation 2.8 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Bending forward (N = 28, 37) | -2.1 Units on a scale | Standard Deviation 2.33 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Full day's activities (N = 28, 36) | -2.6 Units on a scale | Standard Deviation 2.07 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Reaching up high (N = 27, 37) | -1.6 Units on a scale | Standard Deviation 2.29 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Climbing steps without aid (N = 28, 37) | -1.9 Units on a scale | Standard Deviation 2.53 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Getting out of an armless chair (N = 28, 37) | -2.5 Units on a scale | Standard Deviation 2.35 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Physically demanding activities (N = 28, 36) | -2.6 Units on a scale | Standard Deviation 2.38 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 16 | Getting up off floor from back (N = 28, 37) | -2.3 Units on a scale | Standard Deviation 2.6 |
Other Pre-specified
Change From Baseline in Each BASFI Component at Week 4
BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Putting on socks (N = 40, 45) | -1.0 Units on a scale | Standard Deviation 2.66 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Bending forward (N = 40, 45) | -1.0 Units on a scale | Standard Deviation 3.19 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Reaching up high (N = 40, 45) | -1.3 Units on a scale | Standard Deviation 2.43 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Getting out of an armless chair (N = 40, 45) | -1.3 Units on a scale | Standard Deviation 2.58 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Getting up off floor from back (N = 40, 45) | -1.6 Units on a scale | Standard Deviation 2.91 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Standing unsupported 10 min (N = 40, 45) | -1.0 Units on a scale | Standard Deviation 2.57 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Climbing steps without aid (N = 40, 45) | -0.4 Units on a scale | Standard Deviation 3 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Looking over shoulder | -1.6 Units on a scale | Standard Deviation 2.7 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Physically demanding activities (N = 40, 45) | -1.2 Units on a scale | Standard Deviation 2.34 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Full day's activities (N = 40, 45) | -1.1 Units on a scale | Standard Deviation 2.42 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Looking over shoulder | -0.2 Units on a scale | Standard Deviation 2.15 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Putting on socks (N = 40, 45) | -0.4 Units on a scale | Standard Deviation 1.72 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Standing unsupported 10 min (N = 40, 45) | 0.0 Units on a scale | Standard Deviation 2.57 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Bending forward (N = 40, 45) | -0.2 Units on a scale | Standard Deviation 1.96 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Full day's activities (N = 40, 45) | -0.4 Units on a scale | Standard Deviation 1.75 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Reaching up high (N = 40, 45) | -0.3 Units on a scale | Standard Deviation 1.62 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Climbing steps without aid (N = 40, 45) | -0.5 Units on a scale | Standard Deviation 2.04 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Getting out of an armless chair (N = 40, 45) | -0.5 Units on a scale | Standard Deviation 1.69 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Physically demanding activities (N = 40, 45) | -0.4 Units on a scale | Standard Deviation 1.93 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 4 | Getting up off floor from back (N = 40, 45) | -0.4 Units on a scale | Standard Deviation 1.69 |
Other Pre-specified
Change From Baseline in Each BASFI Component at Week 8
BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Putting on socks (N = 37, 43) | -1.3 Units on a scale | Standard Deviation 2.64 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Bending forward (N = 37, 43) | -1.8 Units on a scale | Standard Deviation 3.1 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Reaching up high (N = 37, 43) | -1.3 Units on a scale | Standard Deviation 3.09 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Getting out of an armless chair (N = 37, 43) | -2.1 Units on a scale | Standard Deviation 2.78 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Getting up off floor from back (N = 37, 43) | -2.3 Units on a scale | Standard Deviation 3.01 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Standing unsupported 10 min (N = 37, 43) | -1.6 Units on a scale | Standard Deviation 2.66 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Climbing steps without aid (N = 37, 43) | -1.2 Units on a scale | Standard Deviation 3.22 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Looking over shoulder (N = 37, 43) | -2.4 Units on a scale | Standard Deviation 2.79 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Physically demanding activities (N = 37, 41) | -1.8 Units on a scale | Standard Deviation 2.11 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Full day's activities (N = 37, 41) | -1.4 Units on a scale | Standard Deviation 2.63 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Looking over shoulder (N = 37, 43) | -0.8 Units on a scale | Standard Deviation 1.71 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Putting on socks (N = 37, 43) | -0.3 Units on a scale | Standard Deviation 2.18 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Standing unsupported 10 min (N = 37, 43) | -0.8 Units on a scale | Standard Deviation 2.67 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Bending forward (N = 37, 43) | -0.4 Units on a scale | Standard Deviation 2.08 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Full day's activities (N = 37, 41) | -1.2 Units on a scale | Standard Deviation 2.04 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Reaching up high (N = 37, 43) | -0.7 Units on a scale | Standard Deviation 2.02 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Climbing steps without aid (N = 37, 43) | -0.9 Units on a scale | Standard Deviation 2.26 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Getting out of an armless chair (N = 37, 43) | -1.0 Units on a scale | Standard Deviation 2.23 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Physically demanding activities (N = 37, 41) | -1.2 Units on a scale | Standard Deviation 1.91 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Each BASFI Component at Week 8 | Getting up off floor from back (N = 37, 43) | -0.6 Units on a scale | Standard Deviation 2.33 |
Other Pre-specified
Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16
Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).
Time frame: Weeks 4, 8, 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 | Week 4 (N = 23, 27) | -0.7 Units on a scale | Standard Deviation 2.55 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 | Week 8 (N = 20, 24) | -1.1 Units on a scale | Standard Deviation 2.42 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 | Week 12 (N = 14, 13) | -1.0 Units on a scale | Standard Deviation 2.94 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 | Week 16 (N = 13, 10) | -0.6 Units on a scale | Standard Deviation 2.57 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 | Week 16 (N = 13, 10) | -1.4 Units on a scale | Standard Deviation 3.27 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 | Week 4 (N = 23, 27) | -0.3 Units on a scale | Standard Deviation 2.31 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 | Week 12 (N = 14, 13) | 0.0 Units on a scale | Standard Deviation 2.77 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 | Week 8 (N = 20, 24) | -0.7 Units on a scale | Standard Deviation 2.55 |
Other Pre-specified
Change From Baseline in Nocturnal Back Pain at Week 4
Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Nocturnal Back Pain at Week 4 | -2.13 Units on a scale | Standard Error 0.4 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Nocturnal Back Pain at Week 4 | -0.82 Units on a scale | Standard Error 0.38 |
Comparison: ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factorp-value: 0.019895% CI: [-2.4, -0.21]ANCOVA
Other Pre-specified
Change From Baseline in Nocturnal Back Pain at Week 8
Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Nocturnal Back Pain at Week 8 | -2.71 Units on a scale | Standard Error 0.43 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Nocturnal Back Pain at Week 8 | -1.20 Units on a scale | Standard Error 0.41 |
Comparison: ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factorp-value: 0.013295% CI: [-2.69, -0.32]ANCOVA
Other Pre-specified
Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16
Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time frame: Weeks 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16 | Week 12 (N = 36, 42) | -3.0 Units on a scale | Standard Deviation 2.88 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16 | Week 16 (N = 28, 37) | -2.9 Units on a scale | Standard Deviation 2.14 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16 | Week 12 (N = 36, 42) | -3.0 Units on a scale | Standard Deviation 2.98 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16 | Week 16 (N = 28, 37) | -3.5 Units on a scale | Standard Deviation 2.72 |
Other Pre-specified
Change From Baseline in PGA at Weeks 12 and 16
Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).
Time frame: Weeks 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in PGA at Weeks 12 and 16 | Week 12 (N = 35, 38) | -3.5 Units on a scale | Standard Deviation 2.73 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in PGA at Weeks 12 and 16 | Week 16 (N = 29, 37) | -3.7 Units on a scale | Standard Deviation 2.22 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in PGA at Weeks 12 and 16 | Week 12 (N = 35, 38) | -3.4 Units on a scale | Standard Deviation 1.54 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in PGA at Weeks 12 and 16 | Week 16 (N = 29, 37) | -3.8 Units on a scale | Standard Deviation 2 |
Other Pre-specified
Change From Baseline in PGA (Physician Global Assessment) at Week 4
The investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in PGA (Physician Global Assessment) at Week 4 | -2.05 Units on a scale | Standard Error 0.3 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in PGA (Physician Global Assessment) at Week 4 | -0.71 Units on a scale | Standard Error 0.28 |
Comparison: ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factorp-value: 0.001795% CI: [-2.16, -0.52]ANCOVA
Other Pre-specified
Change From Baseline in PGA (Physician Global Assessment) at Week 8
Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in PGA (Physician Global Assessment) at Week 8 | -2.69 Units on a scale | Standard Error 0.35 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in PGA (Physician Global Assessment) at Week 8 | -1.58 Units on a scale | Standard Error 0.33 |
Comparison: ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor.p-value: 0.023395% CI: [-2.07, -0.16]ANCOVA
Other Pre-specified
Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16
Swollen joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.
Time frame: Weeks 4, 8, 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 | Week 4 (N = 23, 22) | -0.6 Swollen joints | Standard Deviation 1.65 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 | Weel 12 (N = 11, 15) | -0.5 Swollen joints | Standard Deviation 1.29 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 | Week 8 (N = 14, 22) | -0.1 Swollen joints | Standard Deviation 2.09 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 | Week 16 (N = 9, 9) | -1.1 Swollen joints | Standard Deviation 2.89 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 | Week 8 (N = 14, 22) | 0.0 Swollen joints | Standard Deviation 1.25 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 | Week 4 (N = 23, 22) | 0.0 Swollen joints | Standard Deviation 1.09 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 | Week 16 (N = 9, 9) | 2.3 Swollen joints | Standard Deviation 6.65 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 | Weel 12 (N = 11, 15) | -0.3 Swollen joints | Standard Deviation 1.23 |
Other Pre-specified
Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16
Tender joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.
Time frame: Weeks 4, 8, 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 | Week 4 (N = 23, 22) | -1.2 Tender joints | Standard Deviation 3.61 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 | Week 8 (N = 14, 22) | -2.3 Tender joints | Standard Deviation 5.11 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 | Week 12 (N = 11, 15) | -1.3 Tender joints | Standard Deviation 5 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 | Week 16 (N = 9, 9) | -1.9 Tender joints | Standard Deviation 5.64 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 | Week 16 (N = 9, 9) | 0.2 Tender joints | Standard Deviation 9.93 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 | Week 4 (N = 23, 22) | -2.4 Tender joints | Standard Deviation 7.57 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 | Week 12 (N = 11, 15) | -1.4 Tender joints | Standard Deviation 10.7 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 | Week 8 (N = 14, 22) | -3.1 Tender joints | Standard Deviation 6.47 |
Other Pre-specified
Change From Baseline in Total Back Pain at Week 4
Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time frame: Week 4
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Week 4 | -1.59 Units on a scale | Standard Error 0.36 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Week 4 | -0.58 Units on a scale | Standard Error 0.34 |
Comparison: ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor.p-value: 0.047495% CI: [-2, -0.01]ANCOVA
Other Pre-specified
Change From Baseline in Total Back Pain at Week 8
Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Week 8 | -2.24 Units on a scale | Standard Error 0.39 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Week 8 | -0.96 Units on a scale | Standard Error 0.37 |
Comparison: ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factorp-value: 0.021295% CI: [-2.36, -0.2]ANCOVA
Other Pre-specified
Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16
Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).
Time frame: Weeks 4, 8, 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 | Week 4 (N = 40, 45) | -1.1 Units on a scale | Standard Deviation 2.1 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 | Week 8 (N = 37, 43) | -1.7 Units on a scale | Standard Deviation 2.28 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 | Week 12 (N= 36, 42) | -2.6 Units on a scale | Standard Deviation 2.62 |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 | Week 16 (N = 28, 37) | -2.9 Units on a scale | Standard Deviation 2.17 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 | Week 16 (N = 28, 37) | -2.6 Units on a scale | Standard Deviation 2.33 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 | Week 4 (N = 40, 45) | -0.3 Units on a scale | Standard Deviation 1.32 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 | Week 12 (N= 36, 42) | -2.6 Units on a scale | Standard Deviation 2.34 |
| Placebo to Open Label ETN 50 mg Group | Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 | Week 8 (N = 37, 43) | -0.8 Units on a scale | Standard Deviation 1.72 |
Other Pre-specified
Number of Participants With MCII at Weeks 4, 12 and 16
MCII was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.
Time frame: Weeks 4, 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With MCII at Weeks 4, 12 and 16 | Week 4 (N = 40, 44) | 19 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With MCII at Weeks 4, 12 and 16 | Week 12 (N = 36, 42) | 25 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With MCII at Weeks 4, 12 and 16 | Week 16 (N = 28, 37) | 22 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With MCII at Weeks 4, 12 and 16 | Week 4 (N = 40, 44) | 11 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With MCII at Weeks 4, 12 and 16 | Week 12 (N = 36, 42) | 25 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With MCII at Weeks 4, 12 and 16 | Week 16 (N = 28, 37) | 22 Participants |
Other Pre-specified
Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16
MCID was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCID was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCID was evaluated based on participant's opinion on the following three items for the question of how have they been during the last 48 hours compared to Screening visit: 'improved-less pain', 'no change', and 'worse-more pain'. Participants were further asked the importance of worsening i.e., very important, moderately important, slightly important and not at all important as MCID evaluation criteria.
Time frame: Weeks 4, 8, 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 | Week 4 (N = 40, 44) | 3 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 | Week 8 (N = 37, 43) | 0 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 | Week 12 (N = 36, 42) | 0 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 | Week 16 (N = 28, 37) | 0 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 | Week 16 (N = 28, 37) | 0 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 | Week 4 (N = 40, 44) | 9 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 | Week 12 (N = 36, 42) | 0 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 | Week 8 (N = 37, 43) | 3 Participants |
Other Pre-specified
Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8
MCII was completed at visit weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain'. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8 | 21 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8 | 17 Participants |
Comparison: Week 8 was analyzed using logistic regression with baseline score and treatment group included as covariates.p-value: 0.12695% CI: [0.822, 4.901]Regression, Logistic
Other Pre-specified
Number of Participants With PASS at Weeks 4, 12 and 16
PASS is defined as a symptom state that the participants consider acceptable. The PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.
Time frame: Weeks 4, 12 and 16
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With PASS at Weeks 4, 12 and 16 | Week 4 (N = 40, 44) | 19 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With PASS at Weeks 4, 12 and 16 | Week 12 (N = 36, 42) | 23 Participants |
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With PASS at Weeks 4, 12 and 16 | Week 16 (N = 28, 37) | 20 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With PASS at Weeks 4, 12 and 16 | Week 4 (N = 40, 44) | 14 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With PASS at Weeks 4, 12 and 16 | Week 12 (N = 36, 42) | 29 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With PASS at Weeks 4, 12 and 16 | Week 16 (N = 28, 37) | 28 Participants |
Other Pre-specified
Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8
PASS is defined as a symptom state that the participants consider acceptable. PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.
Time frame: Week 8
Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Blind ETN 50 mg to Open Label ETN 50 mg Group | Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8 | 22 Participants |
| Placebo to Open Label ETN 50 mg Group | Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8 | 16 Participants |
Comparison: Logistic regression with baseline morning stiffness score and treatment group included as covariates. Week 8 was analyzed using a logistic regression to assess treatment effect.p-value: 0.049895% CI: [1, 6.08]Regression, Logistic