Early Rheumatoid Arthritis or Early Undiffentiated ArthritisESPOIRNCT03666091
Study and Monitoring of Early Undifferentiated Arthritis
An observational study of Early Rheumatoid Arthritis or Early Undiffentiated Arthritis, run by Societe Francaise de Rhumatologie.
Trial summary
The French Society of Rheumatology initiated a large national multicenter, longitudinal and prospective cohort, ESPOIR, in order to set up databases to allow various investigations on diagnosis, prognostic markers, epidemiology, pathogenesis and medico-economic factors in the field of early arthritis and rheumatoid… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Early Rheumatoid Arthritis or Early Undiffentiated Arthritis
- How many people
- 813 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2002to 13 Jul 2025
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 814 patients with early arthritis were included be- tween November 2002 and april 2005.One patient removed his consent form. All the centres were active and each regional centre recruited between 35 and 83 patients.
Who may be able to join
- patients aged over 18 and under 70
- clinical diagnosis of rheumatoid arthritis as certain or probable
- clinical diagnosis of undifferentiated arthritis potentially becoming rheumatoid arthritis
- at least 2 inflammatory joints since 6 weeks : a swollen joint has to be observed in two articular sites and be present since at least 6 weeks
- arthritis starting since less than 6 months
- never prescribed DMARDS, corticoids, except if less than 2 weeks or except intra-articular injection less than 6 weeks before inclusion
- corticosteroids could be tolerated if prescribed for duration less than 2 weeks in the month before the inclusion with an average dose less than 20 mg per day and stopped two weeks before inclusion
Who cannot join
- patients aged less than 18 years or aged more than 70 years
- pregnant women
- undifferentiated rheumatism with no potential chance to become rheumatoid arthritis
- other inflammatory rheumatisms clearly defined
About this study
Official title: Etude et Suivi Des POlyarthrites Indifférenciées Récentes
The French Society of Rheumatology initiated a large national multicenter, longitudinal and prospective cohort, ESPOIR, in order to set up databases to allow various investigations on diagnosis, prognostic markers, epidemiology, pathogenesis and medico-economic factors in the field of early arthritis and rheumatoid arthritis.
The primary objective is to set-up a multicentre cohort of early arthritis (less than 6 months) in France that could serve as a database to studies of various natures.
Read more
Specific objectives are in the following domains:
- diagnosis: to help determine among clinical, biological, radiographic and immunogenetics those parameters allowing for the earliest diagnosis classification as possible, in order to target early therapy;
- prognosis: to identify early those patients at risk of severe disease by investigating among clinical, biological, genetic and sociologic factors;
- medico-economic: to identify the costs and their determinants at various disease stage;
- pathologic: to collect a databank of sera, DNA, RNA to allow for studies of transcriptomes and other genomics.
Secondary objectives are twofold:
- to monitor adverse events, particularly rare drug adverse events, in collaboration with other international studies
- to allow access to the data collected in this cohort study in order to facilitate new projects submitted to and approved by the scientific committee.
Read the detailed description
All patients were referred to each regional center every 6 months during the first 2 years, then every year. Procedures were set up to avoid patients lost to followup as much as possible. At baseline and at each visit, we recorded data for a set of clinical and biological variables recommended for the management of early arthritis. At each visit, rheumatoid arthritis was classified according to the 1987 American College of Rheumatology (ACR) criteria and retrospectively to the 2010 ACR/European League Against Rheumatism (EULAR) criteria.
At each visit, patients completed function and quality-of-life self-administered questionnaires including the Health Assessment Questionnaire-Disability Index (HAQ-DI), Arthritis Impact Measurement Scales version 2 short form, a medico economic questionnaire, and globally assessed disease, pain at rest and pain during motion on a visual analog scale (VAS). Patients underwent radiographs of the hand and wrist (face) and foot (face and oblique). Radiographs were stored in the radiological coordinating center (Brest) and then were evaluated by the van der Heijde-modified Sharp score. Serum, DNA, urine, were collected at baseline. Serum and urine were also obtained at each follow-up visit. They were then sent and stored in adequate and definite conditions in the biological coordinating centre (Paris-Bichat).
- Keywords
- ESPOIR cohort RA Early Undifferentiated Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Remaining in the cohort.
Presence of the patient at the visit.
Measured: 20 years
Prescription of synthetic or biologic disease-modifying antirheumatic drugs (DMARD).
Number of patients treated or not.
Measured: 20 years
Patient disability evaluation.
Evaluation by Health Assessment Questionnaire Disability Index (HAQ-DI). The following categories are assessed by the HAQ-DI: dressing and grooming, arising, eating, walking, hygiene, reach, grip, common daily activities. The patients report the amount of difficulty they have in performing some of these activities. Each question asks on a scale ranging from 0 to 3. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.
Measured: 20 years
Change in Disease Activity (levels of activity or remission)
- Disease Activity Score (DAS28). The DAS28 provides an absolute indication of RA disease activity on a scale of 0.49 to 9.07 A DAS28 value >5.1 corresponds to a high disease activity, A DAS28 value between 3.2 and 5.1 corresponds to a moderate disease activity, A DAS28 value between 2.6 and 3.2 corresponds to a low disease activity, A DAS28 value < 2.6 corresponds to remission.
- Physician and patient activity VAS. Scales from 0 to 100. A high value indicates extreme activity.
Measured: 20 years
Quality of life assessed by EQ-5D-3L/ EUROQOL
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The EQ VAS records the respondent's self-rated health (0-100).
Measured: 20 years
Quality of life assessed by MOS-SF-36/ MOS 36-Item Short-Form Health Survey
MOS-SF-36/ MOS 36-Item Short-Form Health Survey contains 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides the perceived change in health. Each dimension has a scale (0-100). Low score=poor quality of life.
Measured: 15 years (from baseline to 15 years)
Quality of life assessed by AIMS2-SF/Arthritis Impact Measurement Scales 2 Short Form
AIMS2-SF/Arthritis Impact Measurement Scales 2 Short Form contains 26 items : upper-extremity functioning, lower-extremity functioning, affect, symptoms, social interaction, and role. Scores are summed and converted to a range of 0-10. Higher scores=poorer health.
Measured: 14 years (from baseline to 14 years)
Radiographic damage evaluation
Structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components.The SHS method evaluates, in each hand, 16 areas for erosions and 15 areas for JSN, and, in each foot, 6 areas for erosions and 6 areas for JSN. The erosion score per hand joint can range from 0 to 5. JSN and joint subluxation or luxation are combined in a single score, from 0 to 4. The maximal score for erosion and JSN are 160 and 120, respectively, for the hands and 120 and 48, respectively, for the feet. The maximal total SHS is 448.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start13 Nov 2002
- Primary completion19 Apr 2005
- Study completion13 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Early Rheumatoid Arthritis or Early Undiffentiated ArthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 813 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societe Francaise de Rhumatologie
- Sponsor type
- University, hospital or other
- Collaborators
- Amiens University Hospital, University Hospital, Bordeaux, University Hospital, Brest, University Hospital, Lille, University Hospital, Montpellier, Saint Antoine University Hospital, Pitié-Salpêtrière Hospital, Hôpital Cochin, Bicetre Hospital, Bichat Hospital, University Hospital, Rouen, University Hospital, Strasbourg, France, University Hospital, Toulouse, University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Bernard COMBE, MD, PHD, Principal investigator, Montpellier University Hospital rheumatology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666091
- Sponsor's protocol ID
- P030717
- Acronym
- ESPOIR
- Status last verified
- Jul 2025
- First submitted
- 31 Aug 2018
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garnero P, Falkenlove Madsen S, Eymard F, Sellam J, Chapurlat R, Bay-Jensen AC. Serum biochemical marker of synovial tissue turnover, C1M, predicts radiological progression in early rheumatoid arthritis. RMD Open. 2025 Jul 10;11(3):e005501. doi: 10.1136/rmdopen-2025-005501.
PubMed 40639877Vittecoq O, Guillou C, Hardouin J, Gerard B, Berenbaum F, Constantin A, Rincheval N, Combe B, Lequerre T, Cosette P. Validation in the ESPOIR cohort of vitamin K-dependent protein S (PROS) as a potential biomarker capable of predicting response to the methotrexate/etanercept combination. Arthritis Res Ther. 2022 Mar 21;24(1):72. doi: 10.1186/s13075-022-02762-5.
PubMed 35313956Kumaradev S, Roux C, Sellam J, Perrot S, Pham T, Dugravot A, Molto A. Socio-demographic determinants in the evolution of pain in inflammatory rheumatic diseases: results from ESPOIR and DESIR cohorts. Rheumatology (Oxford). 2022 Apr 11;61(4):1496-1509. doi: 10.1093/rheumatology/keab562.
PubMed 34270700Roubille C, Coffy A, Rincheval N, Dougados M, Flipo RM, Daures JP, Combe B. Ten-year analysis of the risk of severe outcomes related to low-dose glucocorticoids in early rheumatoid arthritis. Rheumatology (Oxford). 2021 Aug 2;60(8):3738-3746. doi: 10.1093/rheumatology/keaa850.
PubMed 33320245Valdeyron C, Soubrier M, Pereira B, Constantin A, Morel J, Gaudin P, Combe B, Gremeau AS, Dejou-Bouillet L, Pouly JL, Sapin V, Oris C, Brugnon F. Impact of disease activity and treatments on ovarian reserve in patients with rheumatoid arthritis in the ESPOIR cohort. Rheumatology (Oxford). 2021 Apr 6;60(4):1863-1870. doi: 10.1093/rheumatology/keaa535.
PubMed 33147613Mouterde G, Gamon E, Rincheval N, Lukas C, Seror R, Berenbaum F, Dupuy AM, Daien C, Daures JP, Combe B. Association Between Vitamin D Deficiency and Disease Activity, Disability, and Radiographic Progression in Early Rheumatoid Arthritis: The ESPOIR Cohort. J Rheumatol. 2020 Nov 1;47(11):1624-1628. doi: 10.3899/jrheum.190795. Epub 2019 Dec 15.
PubMed 31839594Lukas C, Mary J, Debandt M, Daien C, Morel J, Cantagrel A, Fautrel B, Combe B. Predictors of good response to conventional synthetic DMARDs in early seronegative rheumatoid arthritis: data from the ESPOIR cohort. Arthritis Res Ther. 2019 Nov 15;21(1):243. doi: 10.1186/s13075-019-2020-x.
PubMed 31730497
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude et Suivi Des POlyarthrites Indifférenciées Récentes
- ClinicalTrials.gov ID
- NCT03666091
- Acronym / sponsor ID
- ESPOIR / P030717
- Keywords
- ESPOIR cohort RA Early Undifferentiated Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 813 participants (actual)
- Lead sponsor
- Societe Francaise de RhumatologieUniversity, hospital or other
- Collaborators
- Amiens University Hospital, University Hospital, Bordeaux, University Hospital, Brest, University Hospital, Lille, University Hospital, Montpellier, Saint Antoine University Hospital, Pitié-Salpêtrière Hospital, Hôpital Cochin, Bicetre Hospital, Bichat Hospital, University Hospital, Rouen, University Hospital, Strasbourg, France, University Hospital, Toulouse, University Hospital, Tours
- Study start
- 13 Nov 2002 (actual)
- Primary completion
- 19 Apr 2005 (actual)
- Study completion
- 13 Jul 2025 (actual)
- First posted
- 11 Sep 2018 (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.
The French Society of Rheumatology initiated a large national multicenter, longitudinal and prospective cohort, ESPOIR, in order to set up databases to allow various investigations on diagnosis, prognostic markers, epidemiology, pathogenesis and medico-economic factors in the field of early arthritis and rheumatoid arthritis.
The primary objective is to set-up a multicentre cohort of early arthritis (less than 6 months) in France that could serve as a database to studies of various natures.
Specific objectives are in the following domains:
- diagnosis: to help determine among clinical, biological, radiographic and immunogenetics those parameters allowing for the earliest diagnosis classification as possible, in order to target early therapy;
- prognosis: to identify early those patients at risk of severe disease by investigating among clinical, biological, genetic and sociologic factors;
- medico-economic: to identify the costs and their determinants at various disease stage;
- pathologic: to collect a databank of sera, DNA, RNA to allow for studies of transcriptomes and other genomics.
Secondary objectives are twofold:
- to monitor adverse events, particularly rare drug adverse events, in collaboration with other international studies
- to allow access to the data collected in this cohort study in order to facilitate new projects submitted to and approved by the scientific committee.
Detailed description
All patients were referred to each regional center every 6 months during the first 2 years, then every year. Procedures were set up to avoid patients lost to followup as much as possible. At baseline and at each visit, we recorded data for a set of clinical and biological variables recommended for the management of early arthritis. At each visit, rheumatoid arthritis was classified according to the 1987 American College of Rheumatology (ACR) criteria and retrospectively to the 2010 ACR/European League Against Rheumatism (EULAR) criteria.
At each visit, patients completed function and quality-of-life self-administered questionnaires including the Health Assessment Questionnaire-Disability Index (HAQ-DI), Arthritis Impact Measurement Scales version 2 short form, a medico economic questionnaire, and globally assessed disease, pain at rest and pain during motion on a visual analog scale (VAS). Patients underwent radiographs of the hand and wrist (face) and foot (face and oblique). Radiographs were stored in the radiological coordinating center (Brest) and then were evaluated by the van der Heijde-modified Sharp score. Serum, DNA, urine, were collected at baseline. Serum and urine were also obtained at each follow-up visit. They were then sent and stored in adequate and definite conditions in the biological coordinating centre (Paris-Bichat).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 814 patients with early arthritis were included be- tween November 2002 and april 2005.One patient removed his consent form. All the centres were active and each regional centre recruited between 35 and 83 patients.
Key inclusion criteria (7 listed)
- patients aged over 18 and under 70
- clinical diagnosis of rheumatoid arthritis as certain or probable
- clinical diagnosis of undifferentiated arthritis potentially becoming rheumatoid arthritis
- at least 2 inflammatory joints since 6 weeks : a swollen joint has to be observed in two articular sites and be present since at least 6 weeks
- arthritis starting since less than 6 months
Key exclusion criteria (4 listed)
- patients aged less than 18 years or aged more than 70 years
- pregnant women
- undifferentiated rheumatism with no potential chance to become rheumatoid arthritis
- other inflammatory rheumatisms clearly defined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Remaining in the cohort.
Time frame: 20 years
Presence of the patient at the visit.
Prescription of synthetic or biologic disease-modifying antirheumatic drugs (DMARD).
Time frame: 20 years
Number of patients treated or not.
Patient disability evaluation.
Time frame: 20 years
Evaluation by Health Assessment Questionnaire Disability Index (HAQ-DI). The following categories are assessed by the HAQ-DI: dressing and grooming, arising, eating, walking, hygiene, reach, grip, common daily activities. The patients report the amount of difficulty they have in performing some of these activities. Each question asks on a scale ranging from 0 to 3. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.
Change in Disease Activity (levels of activity or remission)
Time frame: 20 years
1. Disease Activity Score (DAS28). The DAS28 provides an absolute indication of RA disease activity on a scale of 0.49 to 9.07 A DAS28 value >5.1 corresponds to a high disease activity, A DAS28 value between 3.2 and 5.1 corresponds to a moderate disease activity, A DAS28 value between 2.6 and 3.2 corresponds to a low disease activity, A DAS28 value < 2.6 corresponds to remission. 2. Physician and patient activity VAS. Scales from 0 to 100. A high value indicates extreme activity.
Quality of life assessed by EQ-5D-3L/ EUROQOL
Time frame: 20 years
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The EQ VAS records the respondent's self-rated health (0-100).
Quality of life assessed by MOS-SF-36/ MOS 36-Item Short-Form Health Survey
Time frame: 15 years (from baseline to 15 years)
MOS-SF-36/ MOS 36-Item Short-Form Health Survey contains 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides the perceived change in health. Each dimension has a scale (0-100). Low score=poor quality of life.
Quality of life assessed by AIMS2-SF/Arthritis Impact Measurement Scales 2 Short Form
Time frame: 14 years (from baseline to 14 years)
AIMS2-SF/Arthritis Impact Measurement Scales 2 Short Form contains 26 items : upper-extremity functioning, lower-extremity functioning, affect, symptoms, social interaction, and role. Scores are summed and converted to a range of 0-10. Higher scores=poorer health.
Radiographic damage evaluation
Time frame: 20 years
Structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components.The SHS method evaluates, in each hand, 16 areas for erosions and 15 areas for JSN, and, in each foot, 6 areas for erosions and 6 areas for JSN. The erosion score per hand joint can range from 0 to 5. JSN and joint subluxation or luxation are combined in a single score, from 0 to 4. The maximal score for erosion and JSN are 160 and 120, respectively, for the hands and 120 and 48, respectively, for the feet. The maximal total SHS is 448.
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 26 Aug 2025.
- Derived from this study: PubMed 40639877Garnero P, Falkenlove Madsen S, Eymard F, Sellam J, Chapurlat R, Bay-Jensen AC. Serum biochemical marker of synovial tissue turnover, C1M, predicts radiological progression in early rheumatoid arthritis. RMD Open. 2025 Jul 10;11(3):e005501. doi: 10.1136/rmdopen-2025-005501.
- Derived from this study: PubMed 35313956Vittecoq O, Guillou C, Hardouin J, Gerard B, Berenbaum F, Constantin A, Rincheval N, Combe B, Lequerre T, Cosette P. Validation in the ESPOIR cohort of vitamin K-dependent protein S (PROS) as a potential biomarker capable of predicting response to the methotrexate/etanercept combination. Arthritis Res Ther. 2022 Mar 21;24(1):72. doi: 10.1186/s13075-022-02762-5.
- Derived from this study: PubMed 34270700Kumaradev S, Roux C, Sellam J, Perrot S, Pham T, Dugravot A, Molto A. Socio-demographic determinants in the evolution of pain in inflammatory rheumatic diseases: results from ESPOIR and DESIR cohorts. Rheumatology (Oxford). 2022 Apr 11;61(4):1496-1509. doi: 10.1093/rheumatology/keab562.
- Derived from this study: PubMed 33320245Roubille C, Coffy A, Rincheval N, Dougados M, Flipo RM, Daures JP, Combe B. Ten-year analysis of the risk of severe outcomes related to low-dose glucocorticoids in early rheumatoid arthritis. Rheumatology (Oxford). 2021 Aug 2;60(8):3738-3746. doi: 10.1093/rheumatology/keaa850.
- Derived from this study: PubMed 33147613Valdeyron C, Soubrier M, Pereira B, Constantin A, Morel J, Gaudin P, Combe B, Gremeau AS, Dejou-Bouillet L, Pouly JL, Sapin V, Oris C, Brugnon F. Impact of disease activity and treatments on ovarian reserve in patients with rheumatoid arthritis in the ESPOIR cohort. Rheumatology (Oxford). 2021 Apr 6;60(4):1863-1870. doi: 10.1093/rheumatology/keaa535.
- Derived from this study: PubMed 31839594Mouterde G, Gamon E, Rincheval N, Lukas C, Seror R, Berenbaum F, Dupuy AM, Daien C, Daures JP, Combe B. Association Between Vitamin D Deficiency and Disease Activity, Disability, and Radiographic Progression in Early Rheumatoid Arthritis: The ESPOIR Cohort. J Rheumatol. 2020 Nov 1;47(11):1624-1628. doi: 10.3899/jrheum.190795. Epub 2019 Dec 15.
- Derived from this study: PubMed 31730497Lukas C, Mary J, Debandt M, Daien C, Morel J, Cantagrel A, Fautrel B, Combe B. Predictors of good response to conventional synthetic DMARDs in early seronegative rheumatoid arthritis: data from the ESPOIR cohort. Arthritis Res Ther. 2019 Nov 15;21(1):243. doi: 10.1186/s13075-019-2020-x.
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.
Bernard COMBE, MD, PHD principal investigator
Montpellier University Hospital rheumatology department
Questions about this trial
What is this clinical trial studying?
An observational study of Early Rheumatoid Arthritis or Early Undiffentiated Arthritis, run by Societe Francaise de Rhumatologie.
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 7 inclusion and 4 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 26 Aug 2025. 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.
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?
Remaining in the cohort. (time frame: 20 years). The study lists 8 primary outcomes in all. 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 NCT03666091, which also lists 7 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 26 Aug 2025.