REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST)

December 6, 2021 updated by: Hanyang University Seoul Hospital

Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

448

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    1. AST/ALT > 3.0 X ULN
    2. White blood cell (WBC) < 3000/μL and/or absolute neutrophil count (ANC) < 1500/μL
    3. Platelet count <100,000/μL and/or hemoglobin level <8.5 g/dL
    4. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:

  1. Adalimumab 40mg subcutaneous every 3 weeks (Q3W) from week 0 to week 48.
  2. Etanercept 50mg subcutaneous every 10 days (Q10D) from week 0 to week 48.
  3. Golimumab 50mg (100mg if a participant's body weight ≥ 100kg) subcutaneous every 5 weeks (Q5W) from week 0 to week 48.
  4. Remsima SC 120mg subcutaneous every 3 weeks (Q3W) from week 0 to week 48.
Biological: Adalimumab and its biosimilars
  1. Active substance: Adalimumab
  2. Pharmaceutical form: Prefilled syringe
  3. Concentration: 100mg/mL
  4. Route of administration: Subcutaneous injection
Other Names:
  • Humira
  • Adaloce
Biological: Biological: Etanercept and its biosimilars
  1. Active substance: Etanercept
  2. Pharmaceutical form: Prefilled syringe
  3. Concentration: 50mg/mL
  4. Route of administration: Subcutaneous injection
Other Names:
  • Enbrel
  • Eucept
  • Etalace
Biological: Golimumab
  1. Active substance: Adalimumab
  2. Pharmaceutical form: Prefilled syringe
  3. Concentration: 100mg/mL
  4. Route of administration: Subcutaneous injection
Other Names:
  • Simponi
Biological: Infliximab biosimilar
  1. Active substance: Infliximab
  2. Pharmaceutical form: Prefilled syringe
  3. Concentration: 120mg/mL
  4. Route of administration: Subcutaneous injection
Other Names:
  • Remsima
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:

  1. Adalimumab 40mg subcutaneous every 2 weeks (Q2W) from week 0 to week 48.
  2. Etanercept 50mg subcutaneous every week (QW) from week 0 to week 48.
  3. Golimumab 50mg (100mg if a participant's body weight ≥ 100kg) subcutaneous every 4 weeks (Q4W) from week 0 to week 48.
  4. Remsima SC 120mg subcutaneous every 2 weeks (Q2W) from week 0 to week 48.
Biological: Adalimumab and its biosimilars
  1. Active substance: Adalimumab
  2. Pharmaceutical form: Prefilled syringe
  3. Concentration: 100mg/mL
  4. Route of administration: Subcutaneous injection
Other Names:
  • Humira
  • Adaloce
Biological: Biological: Etanercept and its biosimilars
  1. Active substance: Etanercept
  2. Pharmaceutical form: Prefilled syringe
  3. Concentration: 50mg/mL
  4. Route of administration: Subcutaneous injection
Other Names:
  • Enbrel
  • Eucept
  • Etalace
Biological: Golimumab
  1. Active substance: Adalimumab
  2. Pharmaceutical form: Prefilled syringe
  3. Concentration: 100mg/mL
  4. Route of administration: Subcutaneous injection
Other Names:
  • Simponi
Biological: Infliximab biosimilar
  1. Active substance: Infliximab
  2. Pharmaceutical form: Prefilled syringe
  3. Concentration: 120mg/mL
  4. Route of administration: Subcutaneous injection
Other Names:
  • Remsima

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From week 0 to week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12
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.
Week 24
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.
Week 36
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.
Week 48
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.
Week 12
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.
Week 24
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.
Week 36
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.
Week 48
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.
Week 12
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.
Week 24
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.
Week 36
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.
Week 48
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.
Week 12
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.
Week 24
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.
Week 36
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.
Week 48
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).
Week 12
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).
Week 24
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).
Week 36
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).
Week 48
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.
Week 12
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.
Week 24
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.
Week 36
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.
Week 48
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.
Week 12
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.
Week 24
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.
Week 36
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.
Week 48
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.
Week 24
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.
Week 48
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
Week 24
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
Week 48
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.
Week 24
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.
Week 48
Change from baseline in Erythrocyte sedimentation rate (ESR) at week 12.
Time Frame: Week 12
Week 12
Change from baseline in Erythrocyte sedimentation rate (ESR) at week 24.
Time Frame: Week 24
Week 24
Change from baseline in Erythrocyte sedimentation rate (ESR) at week 36.
Time Frame: Week 36
Week 36
Change from baseline in Erythrocyte sedimentation rate (ESR) at week 48.
Time Frame: Week 48
Week 48
Change from baseline in serum C-Reactive Protein (CRP) level at week 12.
Time Frame: Week 12
Week 12
Change from baseline in serum C-Reactive Protein (CRP) level at week 24.
Time Frame: Week 24
Week 24
Change from baseline in serum C-Reactive Protein (CRP) level at week 36.
Time Frame: Week 36
Week 36
Change from baseline in serum C-Reactive Protein (CRP) level at week 48.
Time Frame: Week 48
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.
Week 24
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.
Week 48
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.
Week 24
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.
Week 48
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)

  1. Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
  2. 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
  3. 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
From week 0 to week 12
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)

  1. Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
  2. 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
  3. 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
From week 12 to week 24
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)

  1. Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
  2. 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
  3. 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
From week 24 to week 36
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)

  1. Equivalent NSAID score 0 = no intake 100 = 150mg diclofenac / 1000mg naproxen / 200mg aceclofenac / 400mg celecoxib / 600mg etodolac / 150mg indomethacin / 15mg meloxicam / 20mg piroxicam
  2. 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
  3. 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
From week 36 to week 48
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.
From week 0 and week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University Seoul Hospital

Collaborators

Linical Korea

Investigators

  • Principal Investigator: Tae-Hwan Kim, MD, PhD, Hanyang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2022

Primary Completion (Anticipated)

October 31, 2024

Study Completion (Anticipated)

October 31, 2024

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC21C0076

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ankylosing Spondylitis

Clinical Trials on Adalimumab and its biosimilars

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe