Ankylosing SpondylitisPhase 4NCT05164198
REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST)
A Phase 4 study testing Adalimumab and its biosimilars, Biological: Etanercept and its biosimilars and Golimumab in people with Ankylosing Spondylitis and Axial Spondyloarthritis, run by Hanyang University Seoul Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis, Axial Spondyloarthritis
- What is being tested?
- Adalimumab and its biosimilars, Biological: Etanercept and its biosimilars and Golimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2022to 31 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Ankylosing Spondylitis, Axial Spondyloarthritis
- Being tested
- Adalimumab and its biosimilars, Biological: Etanercept and its biosimilars, Golimumab, Infliximab biosimilar
- Medical subject headings
- Spondylitis, Ankylosing, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab and its biosimilarsBiological
Also called Humira, Adaloce
- Active substance: Adalimumab
- Pharmaceutical form: Prefilled syringe
- Concentration: 100mg/mL
- Route of administration: Subcutaneous injection
Biological: Etanercept and its biosimilarsBiological
Also called Enbrel, Eucept, Etalace
- Active substance: Etanercept
- Pharmaceutical form: Prefilled syringe
- Concentration: 50mg/mL
- Route of administration: Subcutaneous injection
GolimumabBiological
Also called Simponi
- Active substance: Adalimumab
- Pharmaceutical form: Prefilled syringe
- Concentration: 100mg/mL
- Route of administration: Subcutaneous injection
Infliximab biosimilarBiological
Also called Remsima
- Active substance: Infliximab
- Pharmaceutical form: Prefilled syringe
- Concentration: 120mg/mL
- Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Open-label reduced-dose TNFi | Experimental | 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. Receives: Biological: Adalimumab and its biosimilars; Biological: Biological: Etanercept and its biosimilars; Biological: Golimumab; Biological: Infliximab biosimilar |
| Open-label full-dose TNFi | Active comparator | 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. Receives: Biological: Adalimumab and its biosimilars; Biological: Biological: Etanercept and its biosimilars; Biological: Golimumab; Biological: Infliximab biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who did not experience a flare
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.
Measured: From week 0 to week 48
Secondary outcomes (51)
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at 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.
Measured: Week 12
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at 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.
Measured: Week 24
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at 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.
Measured: Week 36
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at 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.
Measured: Week 48
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 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.
Measured: Week 12
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 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.
Measured: Week 24
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 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.
Measured: Week 36
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 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.
Measured: Week 48
Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at 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.
Measured: Week 12
Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at 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.
Measured: Week 24
Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at 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.
Measured: Week 36
Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at 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.
Measured: Week 48
Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at 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.
Measured: Week 12
Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at 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.
Measured: Week 24
Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at 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.
Measured: Week 36
Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at 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.
Measured: Week 48
Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at 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).
Measured: Week 12
Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at 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).
Measured: Week 24
Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at 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).
Measured: Week 36
Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at 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).
Measured: Week 48
Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at 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.
Measured: Week 12
Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at 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.
Measured: Week 24
Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at 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.
Measured: Week 36
Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at 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.
Measured: Week 48
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at 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.
Measured: Week 12
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at 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.
Measured: Week 24
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at 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.
Measured: Week 36
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at 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.
Measured: Week 48
Change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at 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.
Measured: Week 24
Change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at 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.
Measured: Week 48
Change from baseline in Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) at 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
Measured: Week 24
Change from baseline in Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) at 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
Measured: Week 48
Change from baseline in swollen/tender joint count (0-44) at 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.
Measured: Week 24
Change from baseline in swollen/tender joint count (0-44) at 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.
Measured: Week 48
Change from baseline in Erythrocyte sedimentation rate (ESR) at week 12.
Measured: Week 12
Change from baseline in Erythrocyte sedimentation rate (ESR) at week 24.
Measured: Week 24
Change from baseline in Erythrocyte sedimentation rate (ESR) at week 36.
Measured: Week 36
Change from baseline in Erythrocyte sedimentation rate (ESR) at week 48.
Measured: Week 48
Change from baseline in serum C-Reactive Protein (CRP) level at week 12.
Measured: Week 12
Change from baseline in serum C-Reactive Protein (CRP) level at week 24.
Measured: Week 24
Change from baseline in serum C-Reactive Protein (CRP) level at week 36.
Measured: Week 36
Change from baseline in serum C-Reactive Protein (CRP) level at week 48.
Measured: Week 48
Change from baseline in Assessment of SpondyloArthritis international Society (ASAS)-health index (ASAS-HI) at 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.
Measured: Week 24
Change from baseline in Assessment of SpondyloArthritis international Society (ASAS)-health index (ASAS-HI) at 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.
Measured: Week 48
Change from baseline in 5-level EQ-5D version (EQ-5D-5L) at 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.
Measured: Week 24
Change from baseline in 5-level EQ-5D version (EQ-5D-5L) at 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.
Measured: Week 48
The amount of NSAID intake between week 0 and 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
Measured: From week 0 to week 12
The amount of NSAID intake between week 12 and 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
Measured: From week 12 to week 24
The amount of NSAID intake between week 24 and 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
Measured: From week 24 to week 36
The amount of NSAID intake between week 36 and 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
Measured: From week 36 to week 48
Percentage of patients at Least One Adverse Event (AE) During the study period.
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.
Measured: From week 0 and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start15 Jan 2022 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 4, randomized, parallel, non-inferiority, open-label, multi-center clinical trial
- Masking
- None (open label)
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Linical Korea
- Responsible party
- Sponsor
- Investigators
- Tae-Hwan Kim, MD, PhD, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164198
- Sponsor's protocol ID
- HC21C0076
- Status last verified
- Oct 2021
- First submitted
- 8 Nov 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity
- ClinicalTrials.gov ID
- NCT05164198
- Acronym / sponsor ID
- HC21C0076
- Conditions
- Ankylosing Spondylitis, Axial Spondyloarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Collaborators
- Linical Korea
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 4, randomized, parallel, non-inferiority, open-label, multi-center clinical trial
| Arm | Type | Receives |
|---|---|---|
| Open-label reduced-dose TNFi | Experimental | Biological: Adalimumab and its biosimilars, Biological: Biological: Etanercept and its biosimilars, Biological: Golimumab, Biological: Infliximab biosimilarParticipants 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. |
| Open-label full-dose TNFi | Active comparator | Biological: Adalimumab and its biosimilars, Biological: Biological: Etanercept and its biosimilars, Biological: Golimumab, Biological: Infliximab biosimilarParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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')
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimumab and its biosimilarsAlso: Humira, Adaloce1. Active substance: Adalimumab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 100mg/mL 4. Route of administration: Subcutaneous injection | Biological | Open-label full-dose TNFi, Open-label reduced-dose TNFi |
| Biological: Etanercept and its biosimilarsAlso: Enbrel, Eucept, Etalace1. Active substance: Etanercept 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 50mg/mL 4. Route of administration: Subcutaneous injection | Biological | Open-label full-dose TNFi, Open-label reduced-dose TNFi |
| GolimumabAlso: Simponi1. Active substance: Adalimumab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 100mg/mL 4. Route of administration: Subcutaneous injection | Biological | Open-label full-dose TNFi, Open-label reduced-dose TNFi |
| Infliximab biosimilarAlso: Remsima1. Active substance: Infliximab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 120mg/mL 4. Route of administration: Subcutaneous injection | Biological | Open-label full-dose TNFi, Open-label reduced-dose TNFi |
Primary outcome
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.
51 secondary outcomes
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12.
Time frame: Week 12
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 24.
Time frame: Week 24
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 36.
Time frame: Week 36
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 48.
Time frame: Week 48
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12.
Time frame: Week 12
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 24.
Time frame: Week 24
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 36.
Time frame: Week 36
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 48.
Time frame: Week 48
Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 12.
Time frame: Week 12
Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 24.
Time frame: Week 24
Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 36.
Time frame: Week 36
Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 48.
Time frame: Week 48
Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 12.
Time frame: Week 12
Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 24.
Time frame: Week 24
Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 36.
Time frame: Week 36
Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 48.
Time frame: Week 48
Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 12.
Time frame: Week 12
Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 24.
Time frame: Week 24
Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 36.
Time frame: Week 36
Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 48.
Time frame: Week 48
Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 12.
Time frame: Week 12
Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 24.
Time frame: Week 24
Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 36.
Time frame: Week 36
Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 48.
Time frame: Week 48
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 12.
Time frame: Week 12
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 24.
Time frame: Week 24
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 36.
Time frame: Week 36
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 48.
Time frame: Week 48
Change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at week 24.
Time frame: Week 24
Change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at week 48.
Time frame: Week 48
Change from baseline in Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) at week 24.
Time frame: Week 24
Change from baseline in Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) at week 48.
Time frame: Week 48
Change from baseline in swollen/tender joint count (0-44) at week 24.
Time frame: Week 24
Change from baseline in swollen/tender joint count (0-44) at week 48.
Time frame: Week 48
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Hwan Kim, MD, PhD principal investigator
Hanyang University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab and its biosimilars, Biological: Etanercept and its biosimilars and Golimumab in people with Ankylosing Spondylitis and Axial Spondyloarthritis, run by Hanyang University Seoul Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae-Hwan Kim, MD, PhD (82-2-2290-9245, thkim@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who did not experience a flare (time frame: From week 0 to week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.