ClinicalTrials.gg
RecruitingNCT05927688CAPTAINUpdated Mar 12, 2025

Assessment of Physician Consideration of EPRO's, from Patients with Gout, Rheumatoid Arthritis, Sjogren's Syndrome or Systemic Lupus, on the Frequency of Therapeutic Adjustments

An observational study in Gout, Rheumatoid Arthritis and Sjogren's Syndrome, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
352
Ages
18 Years and older
Sex
All
01

Study summary

Inflammatory rheumatic diseases affect 1% of the population. Treatment of such diseases should be based on disease activity, safety issues and other patient characteristics such as comorbidities (EULAR, 2022), leading to a higher risk of cardiovascular diseases. To this end, the general treat-to-target approach, as recommended in the EULAR guidance, may require several successive treatment lines based on updates to the patients' profile and close monitoring as the keystone of its implementation.

Regular feedback from patients could be used to fuel such strategies. This feedback can be collected using an ePRO (electronic Patient Reported Outcome). The purpose of this study is therefore to assess patient management using the information provided by patients through e-PROs, which will transfer the data provided by the patient to the physician and will notify the investigators via email when a patient has completed a form (no data interpretation or alerts).

The hypothesis is that the more physicians are provided with insights into their patients' health, the more they will function in a treat-to-target approach and the more often they will tend to adjust their patients' treatments.

02

Conditions studied

  • Gout
  • Rheumatoid Arthritis
  • Sjogren's Syndrome
  • Systemic Lupus Erythematosus
03

In context

Gout

345 studies on the registry are indexed under Gout; 49 are open to participants now.

This study's planned enrollment of 352 is above the median of 232 across 52 observational studies indexed under Gout.

Browse Gout studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patient with Gout, Rheumatoid arthritis, Sjogren's syndrome or Systemic lupus erythematosus

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men or women of at least 18 years of age
  • Diagnosed with (at least) one of the following diseases:

    • Rheumatoid arthritis (RA) according to the 2010 EULAR/ACR classification criteria,
    • Gout according to the 2015 EULAR/ACR classification criteria,
    • Systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria
    • Sjogren's Syndrome according to the 2016 EULAR/ACR classification criteria
  • According to local regulations, patient has expressed his/her non-opposition (for France) or has provided written (for Switzerland and Germany) to participate in the study
  • Patient has access to the internet, a functioning email address and a mobile phone number
  • Patient physically and mentally able to use a computer tool connected to the Internet
  • Only in Switzerland \& Germany : patient is covered by a health insurance plan

Exclusion criteria

Exclusion Criteria:

  • Any neurodegenerative disease that alters cognitive faculties
  • cancer
  • Patients who do not have access to the Internet and/or do not master its use in the context of this protocol
  • Unwillingness or inability to adhere to study protocol (language barriers, cognitive disorders...) Subject who is compulsorily detained for psychiatric treatment
  • Patient who cannot be followed for 2 years by the investigating physician
  • Patient over the age of legal majority who is protected, or deprived of liberty by judicial or administrative decision (vulnerable subject)
  • Patient with an estimated shorter than 1 year
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
352 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients whose physician used the electronic platform to access ePRO

    Behavioral: Therapeutic management following access by the physician to his patient's ePROs

  • Patients whose physician did not used the electronic platform and did not access ePRO

    Behavioral: Therapeutic management following access by the physician to his patient's ePROs

Interventions

  • BehavioralTherapeutic management following access by the physician to his patient's ePROs

    Therapeutic management following access by the physician to his patient's ePROs

06

What researchers measure

Primary outcomes

  1. Frequency of therapeutic adjustments

    To assess the relationship between the frequency of therapeutic adjustments over a 12-month period made by rheumatologists who were provided regular patient reported outcomes (PROs) and their use of an electronic platform providing them with these data.

    Time frame: 12 months

Secondary outcomes

  1. Frequency of therapeutic adjustments

    To assess the relationship between the frequency of therapeutic adjustments over a 6-month period made by rheumatologists who were provided regular patient reported outcomes (PROs) and their use of an electronic platform providing them with these data.

    Time frame: 6 months

  2. Frequency of therapeutic adjustments

    To assess the relationship between the frequency of therapeutic adjustments over a 24-month period made by rheumatologists who were provided regular patient reported outcomes (PROs) and their use of an electronic platform providing them with these data.

    Time frame: 24 months

  3. Frequency of flares and exacerbation

    To assess the fluctuation of disease activity and flares - as perceived by the patient

    Time frame: Day 1

  4. Frequency of flares and exacerbation

    To assess the fluctuation of disease activity and flares - as perceived by the patient

    Time frame: 6 months

  5. Frequency of flares and exacerbation

    To assess the fluctuation of disease activity and flares - as perceived by the patient

    Time frame: 12 months

  6. Frequency of flares and exacerbation

    To assess the fluctuation of disease activity and flares - as perceived by the patient

    Time frame: 24 months

  7. RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score

    To assess the overall health of patients

    Time frame: Day 1

  8. RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score

    To assess the overall health of patients

    Time frame: 6 months

  9. RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score

    To assess the overall health of patients

    Time frame: 12 months

  10. RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score

    To assess the overall health of patients

    Time frame: 24 months

  11. HAQ score (Health Assessment Questionnaire) for health assessment

    To assess the overall health of patients

    Time frame: Day 1

  12. HAQ score (Health Assessment Questionnaire) for health assessment

    To assess the overall health of patients

    Time frame: 6 months

  13. HAQ score (Health Assessment Questionnaire) for health assessment

    To assess the overall health of patients

    Time frame: 12 months

  14. HAQ score (Health Assessment Questionnaire) for health assessment

    To assess the overall health of patients

    Time frame: 24 months

  15. IPAQ score (International Physical Activity Questionnaire) to measure physical activity

    To assess patient's physical activity over time

    Time frame: Day 1

  16. IPAQ score (International Physical Activity Questionnaire) to measure physical activity

    To assess patient's physical activity over time

    Time frame: 6 months

  17. IPAQ score (International Physical Activity Questionnaire) to measure physical activity

    To assess patient's physical activity over time

    Time frame: 12 months

  18. IPAQ score (International Physical Activity Questionnaire) to measure physical activity

    To assess patient's physical activity over time

    Time frame: 24 months

  19. PEPPI score (Perceived efficacy in patient-physician interactions)

    To assess the patient-physician relationship

    Time frame: 6 months

  20. PEPPI score (Perceived efficacy in patient-physician interactions)

    To assess the patient-physician relationship

    Time frame: 12 months

  21. PEPPI score (Perceived efficacy in patient-physician interactions)

    To assess the patient-physician relationship

    Time frame: 18 months

  22. PEPPI score (Perceived efficacy in patient-physician interactions)

    To assess the patient-physician relationship

    Time frame: 24 months

  23. Number of times patients logged in to the platform

    To assess the use of the patient portal by patients and associated satisfaction

    Time frame: 6 months

  24. Number of times patients logged in to the platform

    To assess the use of the patient portal by patients and associated satisfaction

    Time frame: 12 months

  25. Number of times patients logged in to the platform

    To assess the use of the patient portal by patients and associated satisfaction

    Time frame: 24 months

  26. Number of times physicians logged in to the platform

    To assess the viewing of patient-reported data by physicians

    Time frame: 6 months

  27. Number of times physicians logged in to the platform

    To assess the viewing of patient-reported data by physicians

    Time frame: 12 months

  28. Number of times physicians logged in to the platform

    To assess the viewing of patient-reported data by physicians

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05927688
Responsible party
Sponsor
First posted
Jul 3, 2023
Start date
Jul 18, 2023
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Mar 12, 2025

Study contacts

Jacques-Eric GOTTENBERG, Professor
Contact
jacques-eric.gottenberg@chru-strasbourg.fr
3 88 12 79 53 ext. +33
Jacques-Eric GOTTENBERG, MD, PhD
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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