Trial record 1 of 4 for:
enbrel | Recruiting, Not yet recruiting Studies | Ankylosing Spondylitis
REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST)
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| ClinicalTrials.gov Identifier: NCT05164198 |
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Recruitment Status :
Not yet recruiting
First Posted : December 20, 2021
Last Update Posted : December 20, 2021
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Sponsor:
Hanyang University Seoul Hospital
Collaborator:
Linical Korea
Information provided by (Responsible Party):
Hanyang University Seoul Hospital
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Brief Summary:
Participants maintaining stable disease activity of Ankylosing Spondylitis (AS) with standard-dose tumor necrosis factor inhibitor (TNFi) treatment will randomly split into two groups: maintaining standard-dose TNFi, versus reduced-dose TNFi. The proportion of participants not underwent flare between the two groups will be analyzed.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ankylosing Spondylitis Axial Spondyloarthritis | Biological: Adalimumab and its biosimilars Biological: Biological: Etanercept and its biosimilars Biological: Golimumab Biological: Infliximab biosimilar | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 448 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Phase 4, randomized, parallel, non-inferiority, open-label, multi-center clinical trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity |
| Estimated Study Start Date : | January 15, 2022 |
| Estimated Primary Completion Date : | October 31, 2024 |
| Estimated Study Completion Date : | October 31, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ankylosing spondylitis
MedlinePlus related topics:
Ankylosing Spondylitis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Open-label reduced-dose TNFi
Participants in the experimental arm will receive one of the intervention below according to the TNFi agent used at baseline:
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Biological: Adalimumab and its biosimilars
Other Names:
Biological: Biological: Etanercept and its biosimilars
Other Names:
Biological: Golimumab
Other Name: Simponi Biological: Infliximab biosimilar
Other Name: Remsima |
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Active Comparator: Open-label full-dose TNFi
Participants in the comparator arm will receive one of the intervention below according to the TNFi agent used at baseline:
|
Biological: Adalimumab and its biosimilars
Other Names:
Biological: Biological: Etanercept and its biosimilars
Other Names:
Biological: Golimumab
Other Name: Simponi Biological: Infliximab biosimilar
Other Name: Remsima |
Primary Outcome Measures :
- Percentage of Participants who did not experience a flare [ Time Frame: From week 0 to week 48 ]
Flare is defined as below:
- A participant was considered to have experienced a flare if the participant had an Ankylosing spondylitis disease activity score (ASDAS) greater or equal to (≥ 2.1) at 2 consecutive visits or an ASDAS greater than (> 3.5) at any visit.
- If a participant had an ASDAS ≥ 2.1 and ≤ 3.5, the participant has an additional visit 4 weeks later and ASDAS is assessed by the investigator to confirm the flare.
The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). Higher scores mean a worse outcome in the all following components.
Secondary Outcome Measures :
- Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12. [ Time Frame: Week 12 ]The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). Higher scores mean a worse outcome in the all following components.
- Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 24. [ Time Frame: Week 24 ]The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). Higher scores mean a worse outcome in the all following components.
- Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 36. [ Time Frame: Week 36 ]The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). Higher scores mean a worse outcome in the all following components.
- Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 48. [ Time Frame: Week 48 ]The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). Higher scores mean a worse outcome in the all following components.
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12. [ Time Frame: Week 12 ]The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 24. [ Time Frame: Week 24 ]The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 36. [ Time Frame: Week 36 ]The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 48. [ Time Frame: Week 48 ]The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.
- Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 12. [ Time Frame: Week 12 ]The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]. Higher scores mean a worse outcome in the all domains.
- Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 24. [ Time Frame: Week 24 ]The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]. Higher scores mean a worse outcome in the all domains.
- Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 36. [ Time Frame: Week 36 ]The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]. Higher scores mean a worse outcome in the all domains.
- Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 48. [ Time Frame: Week 48 ]The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit]. Higher scores mean a worse outcome in the all domains.
- Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 12. [ Time Frame: Week 12 ]The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Higher scores mean a worse outcome in the all domains.
- Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 24. [ Time Frame: Week 24 ]The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Higher scores mean a worse outcome in the all domains.
- Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 36. [ Time Frame: Week 36 ]The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Higher scores mean a worse outcome in the all domains.
- Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 48. [ Time Frame: Week 48 ]The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Higher scores mean a worse outcome in the all domains.
- Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 12. [ Time Frame: Week 12 ]The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).
- Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 24. [ Time Frame: Week 24 ]The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).
- Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 36. [ Time Frame: Week 36 ]The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).
- Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 48. [ Time Frame: Week 48 ]The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).
- Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 12. [ Time Frame: Week 12 ]The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.
- Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 24. [ Time Frame: Week 24 ]The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.
- Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 36. [ Time Frame: Week 36 ]The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.
- Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 48. [ Time Frame: Week 48 ]The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.
- Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 12. [ Time Frame: Week 12 ]The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.
- Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 24. [ Time Frame: Week 24 ]The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.
- Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 36. [ Time Frame: Week 36 ]The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.
- Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 48. [ Time Frame: Week 48 ]The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.
- Change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at week 24. [ Time Frame: Week 24 ]The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA). The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.
- Change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at week 48. [ Time Frame: Week 48 ]The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA). The change from Week 0 is calculated, a negative value indicating improvement and a positive value worsening.
- Change from baseline in Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) at week 24. [ Time Frame: Week 24 ]
The Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) is a disease-specific measure to assess the level of enthesitis in Ankylosing Spondylitis. It is based on clinical examination by assessor who determined by presence (score 1) or absence (score 0) of enthesitis at 13 different sites as below:
- Both 1st costochondral
- Both 7th costochondral
- Both iliac crest
- Both anterior superior iliac spine
- Both posterior superior iliac spine
- Both proximal Achilles tendon
- 5th lumbar spinous process
- Change from baseline in Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) at week 48. [ Time Frame: Week 48 ]
The Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) is a disease-specific measure to assess the level of enthesitis in Ankylosing Spondylitis. It is based on clinical examination by assessor who determined by presence (score 1) or absence (score 0) of enthesitis at 13 different sites as below:
- Both 1st costochondral
- Both 7th costochondral
- Both iliac crest
- Both anterior superior iliac spine
- Both posterior superior iliac spine
- Both proximal Achilles tendon
- 5th lumbar spinous process
- Change from baseline in swollen/tender joint count (0-44) at week 24. [ Time Frame: Week 24 ]American College of Rheumatology (ACR), swollen joint count were an assessment of 44 joints. Joints are classified as either swollen or not swollen (tender or non-tender). An increase in swollen joints from baseline represented disease progression and/or joint worsening.
- Change from baseline in swollen/tender joint count (0-44) at week 48. [ Time Frame: Week 48 ]American College of Rheumatology (ACR), swollen joint count were an assessment of 44 joints. Joints are classified as either swollen or not swollen (tender or non-tender). An increase in swollen joints from baseline represented disease progression and/or joint worsening.
- Change from baseline in Erythrocyte sedimentation rate (ESR) at week 12. [ Time Frame: Week 12 ]
- Change from baseline in Erythrocyte sedimentation rate (ESR) at week 24. [ Time Frame: Week 24 ]
- Change from baseline in Erythrocyte sedimentation rate (ESR) at week 36. [ Time Frame: Week 36 ]
- Change from baseline in Erythrocyte sedimentation rate (ESR) at week 48. [ Time Frame: Week 48 ]
- Change from baseline in serum C-Reactive Protein (CRP) level at week 12. [ Time Frame: Week 12 ]
- Change from baseline in serum C-Reactive Protein (CRP) level at week 24. [ Time Frame: Week 24 ]
- Change from baseline in serum C-Reactive Protein (CRP) level at week 36. [ Time Frame: Week 36 ]
- Change from baseline in serum C-Reactive Protein (CRP) level at week 48. [ Time Frame: Week 48 ]
- Change from baseline in Assessment of SpondyloArthritis international Society (ASAS)-health index (ASAS-HI) at week 24. [ Time Frame: Week 24 ]The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors (EF) in patients with spondyloarthritis. The ASAS HI contains items addressing categories of pain, emotional functions, sleep, sexual function, mobility, self care, and community life.
- Change from baseline in Assessment of SpondyloArthritis international Society (ASAS)-health index (ASAS-HI) at week 48. [ Time Frame: Week 48 ]The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors (EF) in patients with spondyloarthritis. The ASAS HI contains items addressing categories of pain, emotional functions, sleep, sexual function, mobility, self care, and community life.
- Change from baseline in 5-level EQ-5D version (EQ-5D-5L) at week 24. [ Time Frame: Week 24 ]The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
- Change from baseline in 5-level EQ-5D version (EQ-5D-5L) at week 48. [ Time Frame: Week 48 ]The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
- The amount of NSAID intake between week 0 and 12 [ Time Frame: From week 0 to week 12 ]
The general formula for the calculation is:
(equivalent NSAID score) × (days of intake during period of interest) × (days with intake per week)/(period of interest in days)
- Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
- A scale indicating days with intake per week 0 = did not take any NSAID in a week 0.5/7 = ≤1 day in a week 2/7 = >1 and ≤3 days in a week 4/7 = >3 and ≤5 days in a week 6/7 = >5 days in a week 1 = every day
- days of intake during the period of interest
For example, if during a period of interest of 12 weeks, the patient has taken piroxicam 20 mg for 8 weeks and if during this 8-week period he has taken piroxicam 3-5 days per week the calculation is as follows:
100 (20 mg piroxicam score) × 56 (8 weeks) × 4/7 (3-5 days/week)/84 (12 weeks) = 38.1
- The amount of NSAID intake between week 12 and 24 [ Time Frame: From week 12 to week 24 ]
The general formula for the calculation is:
(equivalent NSAID score) × (days of intake during period of interest) × (days with intake per week)/(period of interest in days)
- Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
- A scale indicating days with intake per week 0 = did not take any NSAID in a week 0.5/7 = ≤1 day in a week 2/7 = >1 and ≤3 days in a week 4/7 = >3 and ≤5 days in a week 6/7 = >5 days in a week 1 = every day
- days of intake during the period of interest
For example, if during a period of interest of 12 weeks, the patient has taken piroxicam 20 mg for 8 weeks and if during this 8-week period he has taken piroxicam 3-5 days per week the calculation is as follows:
100 (20 mg piroxicam score) × 56 (8 weeks) × 4/7 (3-5 days/week)/84 (12 weeks) = 38.1
- The amount of NSAID intake between week 24 and 36 [ Time Frame: From week 24 to week 36 ]
The general formula for the calculation is:
(equivalent NSAID score) × (days of intake during period of interest) × (days with intake per week)/(period of interest in days)
- Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
- A scale indicating days with intake per week 0 = did not take any NSAID in a week 0.5/7 = ≤1 day in a week 2/7 = >1 and ≤3 days in a week 4/7 = >3 and ≤5 days in a week 6/7 = >5 days in a week 1 = every day
- days of intake during the period of interest
For example, if during a period of interest of 12 weeks, the patient has taken piroxicam 20 mg for 8 weeks and if during this 8-week period he has taken piroxicam 3-5 days per week the calculation is as follows:
100 (20 mg piroxicam score) × 56 (8 weeks) × 4/7 (3-5 days/week)/84 (12 weeks) = 38.1
- The amount of NSAID intake between week 36 and 48 [ Time Frame: From week 36 to week 48 ]
The general formula for the calculation is:
(equivalent NSAID score) × (days of intake during period of interest) × (days with intake per week)/(period of interest in days)
- Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
- A scale indicating days with intake per week 0 = did not take any NSAID in a week 0.5/7 = ≤1 day in a week 2/7 = >1 and ≤3 days in a week 4/7 = >3 and ≤5 days in a week 6/7 = >5 days in a week 1 = every day
- days of intake during the period of interest
For example, if during a period of interest of 12 weeks, the patient has taken piroxicam 20 mg for 8 weeks and if during this 8-week period he has taken piroxicam 3-5 days per week the calculation is as follows:
100 (20 mg piroxicam score) × 56 (8 weeks) × 4/7 (3-5 days/week)/84 (12 weeks) = 38.1
- Percentage of patients at Least One Adverse Event (AE) During the study period. [ Time Frame: From week 0 and week 48 ]An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented diagnosis of Ankylosing spondylitis (AS) and meet the modified New York classification criteria for AS.
- Subjects maintaining stable disease (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] < 4) with standard-dose subcutaneous tumor-necrosis factor inhibitor (TNFi) treatment during previous 6 months from screening.
- Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 at screening and 12 weeks prior to screening
- In subjects treated with methotrexate or sulfasalazine, the dose should be maintained (methotrexate≤ 25mg/day, sulfasalazine ≤ 3 g/day) during previous 4 weeks before screening.
- In subjects treated with systemic glucocorticoids, the dose should be less than 10mg/day of predinisolone or equivalent during at least 2 weeks from the screening
- Subjects with stable dose of concomitant NSAID (including Cox2 inhibitors) during the 2 weeks from the randomization
Exclusion Criteria:
- Exposure to more than 1 TNFi
- History of hypersensitivity reaction to any TNFis
- Subjects with concomitant fibromyalgia, as determined by the investigator
- Subjects who have received any TNFis with reduced dosage
- Presence of total spinal ankylosis ('Bamboo spine')
- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- Subjects with a history of malignancies and lymphoproliferative disorder including lymphoma within 5 years (Basal cell carcinoma treated within previous 3 months and showing no evidence of recurrence, actinic keratosis, and treated cervical/colon carcinoma in situ were allowed.)
- Subjects with current or history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac or neurological disease, as determined by the investigator
-
Subjects with significant laboratory abnormalities included but not limited to:
- AST/ALT > 3.0 X ULN
- White blood cell (WBC) < 3000/μL and/or absolute neutrophil count (ANC) < 1500/μL
- Platelet count <100,000/μL and/or hemoglobin level <8.5 g/dL
- Serum creatinine ≥ 1.5 X ULN
- Subjected with any high-potency opioids (ex. methadone, hydromorphone, morphine, oxycodone, oxymorphone, fentanyl, levorphanol, buprenorphine, meperidine)
- Subjects with current acute or chronic viral hepatitis B or C or with human immunodeficiency virus (HIV) infection
- Subjects planning to receive any live attenuated vaccinations after screening
- Subjects has history of chronic alcohol abuse or drug abuse within 6 months from screening
- Subjects concomitantly treated with systemic glucocorticoid (>10mg/day of prednisolone or equivalent doses)
- Subjects with any other condition that, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05164198
Contacts
| Contact: Tae-Hwan Kim, MD, PhD | 82-2-2290-9245 | thkim@hanyang.ac.kr | |
| Contact: Ji Hui Shin | 82-2-2290-9252 | joobaraki77@naver.com |
Sponsors and Collaborators
Hanyang University Seoul Hospital
Linical Korea
Investigators
| Principal Investigator: | Tae-Hwan Kim, MD, PhD | Hanyang University |
| Responsible Party: | Hanyang University Seoul Hospital |
| ClinicalTrials.gov Identifier: | NCT05164198 |
| Other Study ID Numbers: |
HC21C0076 |
| First Posted: | December 20, 2021 Key Record Dates |
| Last Update Posted: | December 20, 2021 |
| Last Verified: | October 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
|
Spondylitis Spondylarthritis Spondylitis, Ankylosing Axial Spondyloarthritis Etanercept Bone Diseases, Infectious Infections Bone Diseases Musculoskeletal Diseases Spinal Diseases Arthritis Joint Diseases Spondylarthropathies Ankylosis Adalimumab |
Infliximab Golimumab Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents Gastrointestinal Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors |