CClinicalTrials.gg
TerminatedNCT03005925SATIE-PRUpdated Sep 30, 2025

Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis

An interventional study of Smartphone and physical follow up in Rheumatoid Arthritis, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2016, registered Dec 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's enrollment of 94 is close to the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    • 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

Exclusion criteria

Exclusion Criteria:

    • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
94 participants (actual)

Study arms

  • Experimental
    connected group

    remote monitoring by smartphone in the care management of patients with rheumatoid arthritis

    Device: Smartphone

  • Active comparator
    control group

    standard outpatient follow-up by physical consultation

    Other: physical follow up

Interventions

  • DeviceSmartphone

    Smartphone application coupled with a hand dynamometer

    Also known as: tele medicine follow up

  • Otherphysical follow up

    regular visits with the specialist

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: follow up of patients over 6 months

  2. Number of consultations

    % of patients who benefit from at least 4 consultations over a 6-month period.

    Time frame: follow up of patients over 6 months

07

Study locations

1 site
  • UH Montpellier
    Montpellier, 34295, France
08

References and documents

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 33020846 ↗
  • Bernard 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03005925
Lead sponsor
University Hospital, Montpellier
Collaborators
European Union, Occitanie Region
Responsible party
Sponsor
First posted
Dec 30, 2016
Start date
Aug 16, 2016
Primary completion
Jul 29, 2019
Completion
Jul 29, 2019
Last update
Sep 30, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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