SpondyloarthritisTeleSpANCT04673825
Monitoring Spondyloarthritis With SpA-Net
A study testing Patient initiated care + telemonitoring in people with Spondyloarthritis and Ankylosing Spondylitis, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
Randomized controlled trial to assess the effectiveness and cost-effectiveness of an intervention combining patient initiated care and telemonitoring through the online eHealth platform SpA-Net versus standard care for patients with spondyloarthritis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spondyloarthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- What is being tested?
- Patient initiated care + telemonitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesNetherlands
- Study dates
- 2 Dec 2020to 1 Jul 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient (18+ years)
- Diagnosis of SpA according to treating physician
- At least 2 years of disease duration, to be familiar with signs, symptoms, and medication
- Stable disease, defined as being in a patient acceptable symptom state according to patient AND treating physician AND no treatment change expected in the next few months
- Access to a computer, tablet and/or smartphone for the entire duration of the study
Who cannot join
- Insufficient mastery of Dutch language
- Incompetent to act for oneself
- Limited life expectancy
- Ongoing (or planned) pregnancy during the study period
- Patients participating in other research project(s)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Medisch Spectrum Twente
Enschede, Overijssel
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Official title: Effectiveness and Cost-effectiveness of Monitoring Spondyloarthritis With the Integrated eHealth System SpA-Net: a Randomized Controlled Trial
Randomized controlled trial to assess the effectiveness and cost-effectiveness of an intervention combining patient initiated care and telemonitoring through the online eHealth platform SpA-Net versus standard care for patients with spondyloarthritis.
Read the detailed description
Multicenter randomized controlled trial to investigate the effectiveness and cost-effectiveness of telemonitoring through SpA-Net, in combination with patient initiated care, versus standard care. Participants will be recruited at the outpatient clinics of participating centers, and will be randomised (after informed consent) into either the telemonitoring or standard care group. Patients in both arms will use SpA-Net and will be followed up for 1 year. Concomitantly a trial-based cost-utility analysis will be performed.
Randomisation (1:1; intervention versus standard care) is done using the minimisation method, stratifying for medical centre, subtype of SpA (axial, peripheral or combined) and treatment (biological use versus no biological use). Due to the nature of the intervention neither patients nor clinicians can be blinded to the allocation.
A sample size of 80 patients per group is necessary to detect the primary outcome with a power of 0.80 and alpha of 0.05. Assuming a 20% drop-out during follow-up, 100 patients per group will be included. This sample size also suffices to show non-inferiority for all secondary objectives with a power of 0.80 and a one-sided alpha of 0.025.
Study endpoints
- The primary endpoint is defined as at least 25% reduction in the number of rheumatology department outpatient visits in the intervention group compared to the standard care group, within a 1-year follow-up period. Due to the COVID-19 pandemic these may also take place through telephone or video calls, replacing physical visits.
- Secondary study parameters/endpoints
- Non-inferiority of telemonitoring compared to standard care with respect to quality of care and health outcomes.
- Non-inferiority with respect to experience with SpA-Net and general rheumatological care.
- Association between patient-reported self-management skills and successful application of telemonitoring
- Experience with telemonitoring through SpA-Net among care providers
- Difference between the populations with regard to healthcare cost per quality adjusted life year (QALY) gained after 1 year
- Difference between the populations with regard to societal cost per QALY gained after 1 year
STATISTICAL ANALYSIS The primary outcome will be analysed in the intention to treat (ITT) population. The differences between the two groups with respect to quality of care aspects and overall resource utilisation will be analysed in the ITT and the per-protocol (PP) population. All other secondary outcomes will be analysed in the ITT population.
The primary endpoint will be compared between both groups with ANOVA. Given that the population is randomised, an equal distribution of baseline characteristics is to be expected. In case differences between the two groups exist on baseline (visually), post-hoc analyses adjusting for these differences will be done (ANCOVA).
Secondary endpoints will be analysed with ANOVA. Post-hoc, subgroup analyses and predictive analyses with respect to self-management skills and and successful application of telemonitoring will be done with linear mixed-effect models with each endpoint as dependent variable and time, group and their interaction as fixed effects. Descriptive statistics will be used to summarize experience with telemonitoring among care providers.
Non-inferiority margins for secondary outcome measures:
- For ASDAS, non-inferiority is defined as an increase of no more than 0.9.
- A change in BASDAI of < 2.0 will be considered non-inferior.
- A cut-off of 20 millimetres is used for the patient global VAS, and a cut-off of 10 millimetres for the physician global VAS.
- An increase in VAS pain of no more than 20 millimetres will be considered non-inferior.
- At the time of the study proposal, approximately 90% of the patients is satisfied with the care provided. Non-inferiority is defined as a decrease of no more than 5%.
Health economic evaluation will be performed in accordance with the ISPOR guidelines, as well as the current Dutch guidelines for economic evaluations in healthcare. Analyses will be done both from a Dutch healthcare and societal perspective.
Currently, no consensus exists with regard to disease weights for SpA. As such, results will be reported for willingness-to-pay thresholds of both 20.000 and 50.000 euros per QALY gained. Sensitivity analyses will be performed to test the robustness of the results gathered.
Missing data will be addressed using multiple imputation.
- Being tested
- Patient initiated care + telemonitoring
- Keywords
- Telemonitoring, Patient initiated care, Remote care, eHealth, Cost-effectiveness
- Medical subject headings
- Spondylarthritis, Spondylitis, Ankylosing, Arthritis, Psoriatic, Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient initiated care + telemonitoringOther
See arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: patient initiated care + telemonitoring | Experimental | Patients in the intervention group will only have a scheduled outpatient visit at baseline and after 1 year. Patients will answer questionnaires and have routine blood tests done before every visit. At 6 months, there will be a remote monitoring check-up and results will be checked by the physician. If indicated, a telephone or video call can take place or a physical visit can be planned. Patients from either arm will be instructed that at any time, they may contact the rheumatology department and extra visits can be scheduled. During the COVID-pandemic, outpatient visits may also take place through telephone or video calls. Receives: Other: Patient initiated care + telemonitoring |
| Control group | No intervention | The standard care group will have a scheduled outpatient visit at baseline and after 1 year, and in between as usual, scheduled at the discretion of the treating rheumatologist. Prior to each visit, patients complete questionnaires in SpA-Net and have routine blood tests done. Patients from either arm will be instructed that at any time, they may contact the rheumatology department and extra visits can be scheduled. During the COVID-pandemic, outpatient visits may also take place through telephone or video calls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of scheduled and unscheduled outpatient visits to the rheumatology department.
Comparison of total number of outpatient visits in a 1-year period between intervention and control group.
Measured: 1 year
Secondary outcomes (13)
Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in ankylosing spondylitis. Parameters included are C-reactive protein value (mg/L) and four self-reported items (0-10, numerical rating scale [NRS]): back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. Higher scores on individual parameters represent more severe symptoms. Higher ASDAS represents higher disease activity.
Measured: 1 year
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
BASDAI consists of 6 questions representing the 5 major symptoms of ankylosing spondylitis (AS), every question is answered by using a 0-10 numerical rating scale with higher scores representing more severe symptoms: fatigue, spinal pain, joint pain / swelling, areas of localized tenderness, morning stiffness duration, morning stiffness severity. The mean of the two scores relating to morning stiffness is taken. The resulting sum of all scores (0 to 50 score) is divided by 5, resulting in a 0 - 10 BASDAI score, with increasing scores representing more active disease.
Measured: 1 year
Global well-being patient
Assesses the patient's global well-being during the last week on a Visual Analogue Scale, range: 0-100 mm. A score of 100 mm represents the worst outcome.
Measured: 1 year
Patient reported pain
Visual Analogue Scale, 0-100 mm. A score of 0 equals no pain. Higher scores represent more severe pain.
Measured: 1 year
Disease activity according to physician
Visual Analogue Scale, 0-100 mm. A score of zero equals no disease activity. Higher scores represent more active disease.
Measured: 1 year
C-Reactive Protein (CRP)
Amount of CRP detected in blood samples, expressed in mg/L.
Measured: 1 year
Tender Joint Count 66 / Swollen Joint Count 68
Only if present, the number of tender (0-66) and swollen (0-68) joints will be evaluated by an independent assessor at each physical outpatient visit.
Measured: 1 year
Presence of dactylitis and/or enthesitis
If present, dactylitis (presence/absence, locations) and enthesitis (presence/absence, locations) will be evaluated by an independent assessor at each physical outpatient visit.
Measured: 1 year
Psoriasis severity: Body Surface Area (BSA)
Measurement of total area of patient's body affected by psoriasis, expressed in percentages (range: 0 - 100).
Measured: 1 year
Psoriasis severity: Nail involvement
Nail changes due to psoriasis will be reported as either present (yes) or absent (no).
Measured: 1 year
36-item Short Form Health Survey (SF-36)
The SF-36 survey contains 36 items, covering eight domains and one single item that provides an indication of perceived change in health. Aggregate percentage scores will be calculated for two components (Mental Component Score [MCS] and Physical Component Score [PCS]). Range: 0% (worst possible level of functioning) to 100% (best possible level of functioning).
Measured: 1 year
EuroQol with 5 dimensions and 5 point Likert scale (EQ-5D-5L)
The EQ-5D-5L evaluates five dimensions, each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. In addition, a vertical Visual Analogue Scale records the patient's self-rated health (range: 'The worst health you can imagine' [0 mm, bottom-end] to 'The best health you can imagine' [100 mm, top-end]).
Measured: 1 year
Assessment of SpondyloArthritis international Society health index (ASAS HI)
The ASAS HI contains 17 dichotomous response items (0 = 'I do not agree'; 1 = 'I agree'). A sum score is calculated, resulting in a total ASAS HI score ranging from 0 to 17. Lower scores indicate a better health status.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 Dec 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, Medisch Spectrum Twente, Dutch Arthritis Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673825
- Sponsor's protocol ID
- NL71041.068.19
- Acronym
- TeleSpA
- Status last verified
- Aug 2023
- First submitted
- 1 Dec 2020
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hermans K, Webers C, Boonen A, Vonkeman HE, van Tubergen A. Patient-initiated follow-up supported by asynchronous telemedicine versus usual care in spondyloarthritis (TeleSpA-study): a randomised controlled trial of clinical and cost-effectiveness. Lancet Rheumatol. 2024 Dec;6(12):e848-e859. doi: 10.1016/S2665-9913(24)00229-7. Epub 2024 Nov 1.
PubMed 39492125Hermans K, Boonen A, Vonkeman HE, van Tubergen A. Effectiveness and cost-effectiveness of combined asynchronous telemonitoring and patient-initiated care for spondyloarthritis: protocol for a pragmatic multicentre randomised controlled trial (TeleSpA Study). BMJ Open. 2023 Feb 20;13(2):e067445. doi: 10.1136/bmjopen-2022-067445.
PubMed 36806136
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of Monitoring Spondyloarthritis With the Integrated eHealth System SpA-Net: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04673825
- Acronym / sponsor ID
- TeleSpA / NL71041.068.19
- Keywords
- Telemonitoring, Patient initiated care, Remote care, eHealth, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University, Medisch Spectrum Twente, Dutch Arthritis Association
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 17 Dec 2020 (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.
Randomized controlled trial to assess the effectiveness and cost-effectiveness of an intervention combining patient initiated care and telemonitoring through the online eHealth platform SpA-Net versus standard care for patients with spondyloarthritis.
Detailed description
Multicenter randomized controlled trial to investigate the effectiveness and cost-effectiveness of telemonitoring through SpA-Net, in combination with patient initiated care, versus standard care. Participants will be recruited at the outpatient clinics of participating centers, and will be randomised (after informed consent) into either the telemonitoring or standard care group. Patients in both arms will use SpA-Net and will be followed up for 1 year. Concomitantly a trial-based cost-utility analysis will be performed.
Randomisation (1:1; intervention versus standard care) is done using the minimisation method, stratifying for medical centre, subtype of SpA (axial, peripheral or combined) and treatment (biological use versus no biological use). Due to the nature of the intervention neither patients nor clinicians can be blinded to the allocation.
A sample size of 80 patients per group is necessary to detect the primary outcome with a power of 0.80 and alpha of 0.05. Assuming a 20% drop-out during follow-up, 100 patients per group will be included. This sample size also suffices to show non-inferiority for all secondary objectives with a power of 0.80 and a one-sided alpha of 0.025.
Study endpoints
- The primary endpoint is defined as at least 25% reduction in the number of rheumatology department outpatient visits in the intervention group compared to the standard care group, within a 1-year follow-up period. Due to the COVID-19 pandemic these may also take place through telephone or video calls, replacing physical visits.
- Secondary study parameters/endpoints
- Non-inferiority of telemonitoring compared to standard care with respect to quality of care and health outcomes.
- Non-inferiority with respect to experience with SpA-Net and general rheumatological care.
- Association between patient-reported self-management skills and successful application of telemonitoring
- Experience with telemonitoring through SpA-Net among care providers
- Difference between the populations with regard to healthcare cost per quality adjusted life year (QALY) gained after 1 year
- Difference between the populations with regard to societal cost per QALY gained after 1 year
STATISTICAL ANALYSIS The primary outcome will be analysed in the intention to treat (ITT) population. The differences between the two groups with respect to quality of care aspects and overall resource utilisation will be analysed in the ITT and the per-protocol (PP) population. All other secondary outcomes will be analysed in the ITT population.
The primary endpoint will be compared between both groups with ANOVA. Given that the population is randomised, an equal distribution of baseline characteristics is to be expected. In case differences between the two groups exist on baseline (visually), post-hoc analyses adjusting for these differences will be done (ANCOVA).
Secondary endpoints will be analysed with ANOVA. Post-hoc, subgroup analyses and predictive analyses with respect to self-management skills and and successful application of telemonitoring will be done with linear mixed-effect models with each endpoint as dependent variable and time, group and their interaction as fixed effects. Descriptive statistics will be used to summarize experience with telemonitoring among care providers.
Non-inferiority margins for secondary outcome measures:
- For ASDAS, non-inferiority is defined as an increase of no more than 0.9.
- A change in BASDAI of < 2.0 will be considered non-inferior.
- A cut-off of 20 millimetres is used for the patient global VAS, and a cut-off of 10 millimetres for the physician global VAS.
- An increase in VAS pain of no more than 20 millimetres will be considered non-inferior.
- At the time of the study proposal, approximately 90% of the patients is satisfied with the care provided. Non-inferiority is defined as a decrease of no more than 5%.
Health economic evaluation will be performed in accordance with the ISPOR guidelines, as well as the current Dutch guidelines for economic evaluations in healthcare. Analyses will be done both from a Dutch healthcare and societal perspective.
Currently, no consensus exists with regard to disease weights for SpA. As such, results will be reported for willingness-to-pay thresholds of both 20.000 and 50.000 euros per QALY gained. Sensitivity analyses will be performed to test the robustness of the results gathered.
Missing data will be addressed using multiple imputation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention: patient initiated care + telemonitoring | Experimental | Other: Patient initiated care + telemonitoringPatients in the intervention group will only have a scheduled outpatient visit at baseline and after 1 year. Patients will answer questionnaires and have routine blood tests done before every visit. At 6 months, there will be a remote monitoring check-up and results will be checked by the physician. If indicated, a telephone or video call can take place or a physical visit can be planned. Patients from either arm will be instructed that at any time, they may contact the rheumatology department and extra visits can be scheduled. During the COVID-pandemic, outpatient visits may also take place through telephone or video calls. |
| Control group | No intervention | –The standard care group will have a scheduled outpatient visit at baseline and after 1 year, and in between as usual, scheduled at the discretion of the treating rheumatologist. Prior to each visit, patients complete questionnaires in SpA-Net and have routine blood tests done. Patients from either arm will be instructed that at any time, they may contact the rheumatology department and extra visits can be scheduled. During the COVID-pandemic, outpatient visits may also take place through telephone or video calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient (18+ years)
- Diagnosis of SpA according to treating physician
- At least 2 years of disease duration, to be familiar with signs, symptoms, and medication
- Stable disease, defined as being in a patient acceptable symptom state according to patient AND treating physician AND no treatment change expected in the next few months
- Access to a computer, tablet and/or smartphone for the entire duration of the study
Key exclusion criteria (5 listed)
- Insufficient mastery of Dutch language
- Incompetent to act for oneself
- Limited life expectancy
- Ongoing (or planned) pregnancy during the study period
- Patients participating in other research project(s)
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 |
|---|---|---|
| Patient initiated care + telemonitoringSee arm/group descriptions. | Other | Intervention: patient initiated care + telemonitoring |
Primary outcome
Number of scheduled and unscheduled outpatient visits to the rheumatology department.
Time frame: 1 year
Comparison of total number of outpatient visits in a 1-year period between intervention and control group.
13 secondary outcomes
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: 1 year
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 1 year
Global well-being patient
Time frame: 1 year
Patient reported pain
Time frame: 1 year
Disease activity according to physician
Time frame: 1 year
C-Reactive Protein (CRP)
Time frame: 1 year
Tender Joint Count 66 / Swollen Joint Count 68
Time frame: 1 year
Presence of dactylitis and/or enthesitis
Time frame: 1 year
Psoriasis severity: Body Surface Area (BSA)
Time frame: 1 year
Psoriasis severity: Nail involvement
Time frame: 1 year
36-item Short Form Health Survey (SF-36)
Time frame: 1 year
EuroQol with 5 dimensions and 5 point Likert scale (EQ-5D-5L)
Time frame: 1 year
Assessment of SpondyloArthritis international Society health index (ASAS HI)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Derived from this study: PubMed 39492125Hermans K, Webers C, Boonen A, Vonkeman HE, van Tubergen A. Patient-initiated follow-up supported by asynchronous telemedicine versus usual care in spondyloarthritis (TeleSpA-study): a randomised controlled trial of clinical and cost-effectiveness. Lancet Rheumatol. 2024 Dec;6(12):e848-e859. doi: 10.1016/S2665-9913(24)00229-7. Epub 2024 Nov 1.
- Derived from this study: PubMed 36806136Hermans K, Boonen A, Vonkeman HE, van Tubergen A. Effectiveness and cost-effectiveness of combined asynchronous telemonitoring and patient-initiated care for spondyloarthritis: protocol for a pragmatic multicentre randomised controlled trial (TeleSpA Study). BMJ Open. 2023 Feb 20;13(2):e067445. doi: 10.1136/bmjopen-2022-067445.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient initiated care + telemonitoring in people with Spondyloarthritis and Ankylosing Spondylitis, run by Maastricht University Medical Center at 2 sites in Netherlands.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of scheduled and unscheduled outpatient visits to the rheumatology department. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04673825, which also lists 2 linked publications.
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 8 Aug 2023.