Rheumatoid ArthritisSATIE-PRNCT03005925
Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis
A study testing Smartphone and physical follow up in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting nearly 0.4% of the general population. It is a real public health issue. International guidelines recommend strict control (remission or low disease activity) of the disease, to avoid joint destruction in order to reduce the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Smartphone and physical follow up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 16 Aug 2016to 29 Jul 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients between 18 and 75 years old with rheumatoid arthritis according to 2010 ACR (American College of Rheumatology) / EULAR Classification Criteria
- Patients that need a treatment initiation for rheumatoid arthritis
- Patients with DAS 28 > 3.2 (Disease Activity Score )
- Patients who agreed to participate in this study and provide the informed consent
Who cannot join
- • Insufficient level of understanding to perform the measurement and self-report questionnaires
- Patients without an internet connection
- Difficulties in using a dynamometer due to a dominant-hand surgery done during the previous 12 months, carpal tunnel symptoms, or ulnar nerve compression, or cervicobrachial neuralgia, known presence of motor dysfunction of the upper extremity, or neurological disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Prospective Randomized Controlled Study Comparing the Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis Versus a Standard Outpatient Follow-up by Physical Consultation
Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting nearly 0.4% of the general population. It is a real public health issue. International guidelines recommend strict control (remission or low disease activity) of the disease, to avoid joint destruction in order to reduce the functional impact of the disease in the long term and to improve the quality of life of the patients.
This care is based on a close follow-up requiring regular visits with the specialist which represents an additional cost (transport, visits). In this context, tele-medicine is often proposed as a complementary approach in the management of these chronic patients.
Thus, the investigators propose to study the interest of a connected device by comparing a group of patients using this Smartphone application, coupled with a hand dynamometer during the 6 months following initiation of a new DMARD.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Smartphone, physical follow up
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartphoneDevice
Also called tele medicine follow up
Smartphone application coupled with a hand dynamometer
physical follow upOther
regular visits with the specialist
| Study group | Role | What they receive |
|---|---|---|
| connected group | Experimental | remote monitoring by smartphone in the care management of patients with rheumatoid arthritis Receives: Device: Smartphone |
| control group | Active comparator | standard outpatient follow-up by physical consultation Receives: Other: physical follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consultation
To evaluate whether the use of a computerized monitoring interface on Smartphone ( "SATIE-PR" application) reduces the number of consultations during follow-up of patients with RA over 6 months
Measured: follow up of patients over 6 months
Number of consultations
% of patients who benefit from at least 4 consultations over a 6-month period.
Measured: follow up of patients over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start16 Aug 2016
- Primary completion29 Jul 2019
- Study completion29 Jul 2019
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 Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, Occitanie Region
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005925
- Sponsor's protocol ID
- RECHMPL_0174
- Acronym
- SATIE-PR
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2016
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pers YM, Valsecchi V, Mura T, Aouinti S, Filippi N, Marouen S, Letaief H, Le Blay P, Autuori M, Fournet D, Mercier G, Ferreira R, Jorgensen C. A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis. Rheumatology (Oxford). 2021 Apr 6;60(4):1659-1668. doi: 10.1093/rheumatology/keaa462.
PubMed 33020846Bernard L, Valsecchi V, Mura T, Aouinti S, Padern G, Ferreira R, Pastor J, Jorgensen C, Mercier G, Pers YM. Management of patients with rheumatoid arthritis by telemedicine: connected monitoring. A randomized controlled trial. Joint Bone Spine. 2022 Oct;89(5):105368. doi: 10.1016/j.jbspin.2022.105368. Epub 2022 Mar 4.
PubMed 35248737
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Prospective Randomized Controlled Study Comparing the Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis Versus a Standard Outpatient Follow-up by Physical Consultation
- ClinicalTrials.gov ID
- NCT03005925
- Acronym / sponsor ID
- SATIE-PR / RECHMPL_0174
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- European Union, Occitanie Region
- Study start
- 16 Aug 2016 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 30 Dec 2016 (estimated)
- 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.
Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting nearly 0.4% of the general population. It is a real public health issue. International guidelines recommend strict control (remission or low disease activity) of the disease, to avoid joint destruction in order to reduce the functional impact of the disease in the long term and to improve the quality of life of the patients.
This care is based on a close follow-up requiring regular visits with the specialist which represents an additional cost (transport, visits). In this context, tele-medicine is often proposed as a complementary approach in the management of these chronic patients.
Thus, the investigators propose to study the interest of a connected device by comparing a group of patients using this Smartphone application, coupled with a hand dynamometer during the 6 months following initiation of a new DMARD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| connected group | Experimental | Device: Smartphoneremote monitoring by smartphone in the care management of patients with rheumatoid arthritis |
| control group | Active comparator | Other: physical follow upstandard outpatient follow-up by physical consultation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Patients between 18 and 75 years old with rheumatoid arthritis according to 2010 ACR (American College of Rheumatology) / EULAR Classification Criteria
Key exclusion criteria (4 listed)
- • Insufficient level of understanding to perform the measurement and self-report questionnaires
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 |
|---|---|---|
| SmartphoneAlso: tele medicine follow upSmartphone application coupled with a hand dynamometer | Device | connected group |
| physical follow upregular visits with the specialist | Other | control group |
Primary outcome
Consultation
Time frame: follow up of patients over 6 months
To evaluate whether the use of a computerized monitoring interface on Smartphone ( "SATIE-PR" application) reduces the number of consultations during follow-up of patients with RA over 6 months
Number of consultations
Time frame: follow up of patients over 6 months
% of patients who benefit from at least 4 consultations over a 6-month period.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 33020846Pers YM, Valsecchi V, Mura T, Aouinti S, Filippi N, Marouen S, Letaief H, Le Blay P, Autuori M, Fournet D, Mercier G, Ferreira R, Jorgensen C. A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis. Rheumatology (Oxford). 2021 Apr 6;60(4):1659-1668. doi: 10.1093/rheumatology/keaa462.
- Derived from this study: PubMed 35248737Bernard L, Valsecchi V, Mura T, Aouinti S, Padern G, Ferreira R, Pastor J, Jorgensen C, Mercier G, Pers YM. Management of patients with rheumatoid arthritis by telemedicine: connected monitoring. A randomized controlled trial. Joint Bone Spine. 2022 Oct;89(5):105368. doi: 10.1016/j.jbspin.2022.105368. Epub 2022 Mar 4.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone and physical follow up in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site 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 4 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: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early. Results are not available in the source record.
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?
Consultation (time frame: follow up of patients over 6 months). The study lists 2 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 NCT03005925, 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 30 Sep 2025.