Rheumatoid ArthritisSMART²TNCT04749160
Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T
An observational study of Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Saint Etienne at 13 sites in France.
Trial summary
European recommendations indicate to start a conventional synthetic disease modifying antirheumatic drug (csDMARD) as soon as possible to reach the remission in early RA or low disease activity in established RA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Connected device
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 13 sitesFrance
- Study dates
- 4 Jun 2021to 20 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RA patient with DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD
Who may be able to join
- Social security affiliation
- Signed informed consent
- Adult patient (over 18 years old)
- RA according to ACR/EULAR 2010 criteria since less than 6 months
- DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD
- Having an internet access at home and using an email address
Who cannot join
- Other arthritis than RA
- To participate to a blind-randomized study to assess RA treatment
- Pregnancy or breastfeeding
- Patient unable to understand the study, unable to give consent
- Patient deprived of liberty or patient under guardianship
- Patient refusing to participate in the study
- Patients having difficulty using connected objects
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Centre Hospitalier de Besancon
Besançon, 25000
Hôpital Pellegrin
Bordeaux
Clinique de l'Infirmerie Protestante deLyon
Caluire-et-Cuire
Centre Hospitalier Universitaire de Clermont Ferrand
Clermont-Ferrand, 63000
Hôpital Sud
Grenoble
CH Le Mans
Le Mans
CHU Montpellier
Montpellier, 34000
Centre Hospitalier D'Orleans
Orléans, 45100
Hôpital Pitié Salpétrière
Paris
CHU de Reims - Hôpital Maison Blanche
Reims
CHU Saint-Etienne
Saint-Etienne, 42055
Hôpital Hautepierre
Strasbourg
Hôpital Pierre-Paul Riquet
Toulouse
About this study
European recommendations indicate to start a conventional synthetic disease modifying antirheumatic drug (csDMARD) as soon as possible to reach the remission in early RA or low disease activity in established RA. If the target is not achieved with the first csDMARD and in presence of poor prognostic, addition of a biologic (b)DMARD or a targeted synthetic (ts)DMARD should be considered . Nevertheless, as many as one-third of patients have persistent disease activity and insufficient (inadequate) response to a first b/tsDMARD according to international recommendations. This relatively long time (3 to 6 months) between treatment initiation and determination of individual clinical response represents:
- a risk for the patient who could be usually exposed to potential side effects,
- a loss of chance for the patient who will not receive an adequate treatment during the most favorable period and thus may develop irreversible lesions
- a cost for the healthcare system, especially in terms of expensive drug reimbursements, notwithstanding the increasing use of biosimilars.
Read more
Despite 20 years of research, no biomarker or no way are available in the daily practice to predict disease activity and the non-response to a b/tDMARD [11]. Thus exploration of a new approach is totally in purpose.
The aim of this project is to benefit from the declarative PRO (Patient Reported Outcomes), the physical activity and sleep quality to predict the individual clinical response to the b/tsDMARDs
- Conditions
- Rheumatoid Arthritis
- Being tested
- Connected device
- Keywords
- Rheumatoid arthritis (RA), synthetic disease modifying antirheumatic drug (csDMARD), biologic disease modifying antirheumatic drug (bDMARD), Machine Learning
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected deviceDevice
Connected device is a smart watch (with accelerometer without location data).
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis (RA) with connected device | RA with DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD.
the physical activity and sleep quality measured with connected device Receives: Device: Connected device |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activities
Physical activities including number of steps per day and per hour. Physical activities are measured with a smart watch (with accelerometer without location data)
Measured: 3 months
physical activities and sleep quality
sleep quality data including time of sleeping (number of hours). sleep quality is measured with a smart watch (with accelerometer without location data)
Measured: 3 months
Rapid-3 score
Routine Assessment of Patient Index Data (Rapid-3) score is a self-administered score demonstrated capacity to capture Rheumatoid arthritis activity (score : 0,0 to 30,0).
Remission : score 0- 3,0 Low Disease Activity : score 3,1- 6,0 Moderate Disease Activity : score 6,1 - 12,0 High Disease Activity : score 12,1 - 30
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start4 Jun 2021
- Primary completion20 Feb 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert MAROTTE, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749160
- Sponsor's protocol ID
- 20CH191
- Other IDs
- 2020-A02737-32
- Acronym
- SMART²T
- Status last verified
- Jan 2024
- First submitted
- 3 Feb 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T
- ClinicalTrials.gov ID
- NCT04749160
- Acronym / sponsor ID
- SMART²T / 20CH191
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis (RA), synthetic disease modifying antirheumatic drug (csDMARD), biologic disease modifying antirheumatic drug (bDMARD), Machine Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 11 Feb 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.
European recommendations indicate to start a conventional synthetic disease modifying antirheumatic drug (csDMARD) as soon as possible to reach the remission in early RA or low disease activity in established RA. If the target is not achieved with the first csDMARD and in presence of poor prognostic, addition of a biologic (b)DMARD or a targeted synthetic (ts)DMARD should be considered . Nevertheless, as many as one-third of patients have persistent disease activity and insufficient (inadequate) response to a first b/tsDMARD according to international recommendations. This relatively long time (3 to 6 months) between treatment initiation and determination of individual clinical response represents:
- a risk for the patient who could be usually exposed to potential side effects,
- a loss of chance for the patient who will not receive an adequate treatment during the most favorable period and thus may develop irreversible lesions
- a cost for the healthcare system, especially in terms of expensive drug reimbursements, notwithstanding the increasing use of biosimilars.
Despite 20 years of research, no biomarker or no way are available in the daily practice to predict disease activity and the non-response to a b/tDMARD [11]. Thus exploration of a new approach is totally in purpose.
The aim of this project is to benefit from the declarative PRO (Patient Reported Outcomes), the physical activity and sleep quality to predict the individual clinical response to the b/tsDMARDs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis (RA) with connected device | – | Device: Connected deviceRA with DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD. the physical activity and sleep quality measured with connected device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA patient with DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD
Key inclusion criteria (6 listed)
- Social security affiliation
- Signed informed consent
- Adult patient (over 18 years old)
- RA according to ACR/EULAR 2010 criteria since less than 6 months
- DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD
Key exclusion criteria (7 listed)
- Other arthritis than RA
- To participate to a blind-randomized study to assess RA treatment
- Pregnancy or breastfeeding
- Patient unable to understand the study, unable to give consent
- Patient deprived of liberty or patient under guardianship
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 |
|---|---|---|
| Connected deviceConnected device is a smart watch (with accelerometer without location data). | Device | Rheumatoid arthritis (RA) with connected device |
Primary outcome
physical activities
Time frame: 3 months
Physical activities including number of steps per day and per hour. Physical activities are measured with a smart watch (with accelerometer without location data)
physical activities and sleep quality
Time frame: 3 months
sleep quality data including time of sleeping (number of hours). sleep quality is measured with a smart watch (with accelerometer without location data)
Rapid-3 score
Time frame: 3 months
Routine Assessment of Patient Index Data (Rapid-3) score is a self-administered score demonstrated capacity to capture Rheumatoid arthritis activity (score : 0,0 to 30,0). Remission : score 0- 3,0 Low Disease Activity : score 3,1- 6,0 Moderate Disease Activity : score 6,1 - 12,0 High Disease Activity : score 12,1 - 30
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 18 Jan 2024.
- 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.
Hubert MAROTTE, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Saint Etienne at 13 sites in France.
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 7 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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?
physical activities (time frame: 3 months). The study lists 3 primary outcomes in all. 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 18 Jan 2024.