Rheumatoid ArthritisNCT05220423
Effectiveness of SMS Reminders on Influenza Vaccination Coverage in Patients With RA in the ART Registry
A study testing sms and emails reminders and No reminders in people with Rheumatoid Arthritis, run by Societe Francaise de Rhumatologie at 1 site in France.
Trial summary
Biotherapies have significantly improved the prognosis of rheumatoid arthritis (RA), particularly anti-TNF. However, these molecules are associated with a well-demonstrated increase in infectious risk, including an over-risk of pneumococcal and influenza infection.. 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?
- sms and emails reminders and No reminders
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2021to 30 Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with RA,
- Patient in whom the specialist physician decides to start treatment with an anti-TNF drug, regardless of the treatment line and regardless of the anti-TNF, including infliximab, adalimumab, etanercept, certolizumab and golimumab, and their respective biosimilar according to their arrival on the market
- Clinicians (hospital-based and private practice) who agree to adhere to the yearly renewal of the hospital prescription
Who cannot join
- Patient already treated by the same anti-TNF in the past (same drug)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of an SMS Reminder on Influenza Vaccination Coverage in Patients With Rheumatoid Arthritis Taking Anti-TNF : an Ancillary Study to the French National Registry ART E-cohort
Biotherapies have significantly improved the prognosis of rheumatoid arthritis (RA), particularly anti-TNF. However, these molecules are associated with a well-demonstrated increase in infectious risk, including an over-risk of pneumococcal and influenza infection.. Therefore, when initiating anti-TNF treatments, it is recommended to update the vaccination schedule of these patients, to vaccinate them against pneumococcus and carry out an annual anti influenza vaccination.. However, vaccination coverage remains sub-optimal. The means to improve this vaccination coverage are multiple but often require human resources. Medical teams often lack time, nursing interventions are effective but again requires the availability of the health care team. The use of modern digital means (automatic reminders) is an attractive alternative to increase immunization coverage without the use of medical or paramedical time.
The objective of the study is to evaluate the effectiveness, in terms of immunization coverage, of SMS and/or email reminders reminding the need to vaccinate against seasonal influenza compared to usual care, in patients with RA on biotherapies participating in the e-cohort of the French ART Registry (NCT03062865).
Read more
This study will be based on the ART Registry e-cohort. This will be a randomized controlled trial in patients in the ART e-cohort. The patients will be allocated in one of the 2 arms : one arm receiving reminders by email and SMS of the influenza vaccination, the other arm with absence of reminders. This study will be conducted during the annual French National communication campaign to encourage influenza vaccination.
The main evaluation criterion will be the influenza vaccination coverage rate at the end of the vaccination campaign. It will be compared between the two arms.
Read the detailed description
Design :
Randomised, controlled trial within the e-cohort population of the French ART registry (observational study)
Target population :
All participants to the e-cohort of the French ART Registry (Rheumatoid Arthritis and anti-TNF)
- Conditions
- Rheumatoid Arthritis
- Being tested
- sms and emails reminders, No reminders
- Keywords
- anti-TNF, Flu, influenza, vaccination, biologics, bDMARDs, targeted therapies
- Medical subject headings
- Arthritis, Rheumatoid, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sms and emails remindersOther
6 reminders encouraging influenza vaccination on top of the National annual communication campaign organized by the French Health System authorities
No remindersOther
no reminders on top of the National annual communication campaign organized by the French Health System authorities
| Study group | Role | What they receive |
|---|---|---|
| Reminders Group | Other | This group will receive 6 reminders (sms/emails) on top of the National annual communication campaign organized by the French Health System authorities Receives: Other: sms and emails reminders |
| No reminders group | Other | This group will receive no reminders on top of the National annual communication campaign organized by the French Health System authorities Receives: Other: No reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza vaccination coverage
The vaccination coverage will be evaluated by comparing the vaccination coverage rate between both groups
Measured: up to 5 months
Secondary outcomes (5)
Influenza vaccination coverage in the non-intervention group post Covid 19 pandemia
Comparison of the actual vaccination rate with the 2019-2020 vaccination rate
Measured: up to 5 months
Factors associated with influenza non-vaccination
identification of the factors associated with the absence of vaccination assessed by questionnaire
Measured: up to 5 months
Reasons for influenza vaccination and non-vaccination
Number of patients for each reason for vaccination and non-vaccination assessed by questionnaire
Measured: up to 5 months
Covid-19 vaccination coverage including primo vaccination, booster
Estimation of the actual covid19 vaccination coverage rate
Measured: up to 5 months
Adherence to national recommendations on COVID vaccination in patients with immunosuppressive treatment
Estimation of the actual covid19 vaccination coverage rate in patients with immunosuppressive treatment
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start19 Oct 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societe Francaise de Rhumatologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphaele Seror, Principal investigator, Hôpital BicêtreAdeline Ruyssen-Witrand, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220423
- Sponsor's protocol ID
- ART- Influenza
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen Y, Baron G, Hamamouche N, Belkhir R, Miconnet S, Soubrier M, Hostachy C, Thevenot P, Basch A, Truchetet ME, Claudepierre P, Dernis E, Marotte H, Flipo RM, Brocq O, Morel J, Fautrel B, Salliot C, Saraux A, Leske C, Schaeverbeke T, Ravaud P, Mariette X, Ruyssen-Witrand A, Seror R; ART Study Group section sign. Do SMS/e-mail reminders increase influenza vaccination of rheumatoid arthritis patients under anti-TNF: a nested randomized controlled trial in the ART e-cohort. Rheumatology (Oxford). 2025 May 1;64(5):2496-2504. doi: 10.1093/rheumatology/keae599.
PubMed 39576675
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an SMS Reminder on Influenza Vaccination Coverage in Patients With Rheumatoid Arthritis Taking Anti-TNF : an Ancillary Study to the French National Registry ART E-cohort
- ClinicalTrials.gov ID
- NCT05220423
- Acronym / sponsor ID
- ART- Influenza
- Conditions
- Rheumatoid Arthritis
- Keywords
- anti-TNF, Flu, influenza, vaccination, biologics, bDMARDs, targeted therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Societe Francaise de RhumatologieUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, University Hospital, Toulouse
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 2 Feb 2022 (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.
Biotherapies have significantly improved the prognosis of rheumatoid arthritis (RA), particularly anti-TNF. However, these molecules are associated with a well-demonstrated increase in infectious risk, including an over-risk of pneumococcal and influenza infection.. Therefore, when initiating anti-TNF treatments, it is recommended to update the vaccination schedule of these patients, to vaccinate them against pneumococcus and carry out an annual anti influenza vaccination.. However, vaccination coverage remains sub-optimal. The means to improve this vaccination coverage are multiple but often require human resources. Medical teams often lack time, nursing interventions are effective but again requires the availability of the health care team. The use of modern digital means (automatic reminders) is an attractive alternative to increase immunization coverage without the use of medical or paramedical time.
The objective of the study is to evaluate the effectiveness, in terms of immunization coverage, of SMS and/or email reminders reminding the need to vaccinate against seasonal influenza compared to usual care, in patients with RA on biotherapies participating in the e-cohort of the French ART Registry (NCT03062865).
This study will be based on the ART Registry e-cohort. This will be a randomized controlled trial in patients in the ART e-cohort. The patients will be allocated in one of the 2 arms : one arm receiving reminders by email and SMS of the influenza vaccination, the other arm with absence of reminders. This study will be conducted during the annual French National communication campaign to encourage influenza vaccination.
The main evaluation criterion will be the influenza vaccination coverage rate at the end of the vaccination campaign. It will be compared between the two arms.
Detailed description
Design :
Randomised, controlled trial within the e-cohort population of the French ART registry (observational study)
Target population :
All participants to the e-cohort of the French ART Registry (Rheumatoid Arthritis and anti-TNF)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reminders Group | Other | Other: sms and emails remindersThis group will receive 6 reminders (sms/emails) on top of the National annual communication campaign organized by the French Health System authorities |
| No reminders group | Other | Other: No remindersThis group will receive no reminders on top of the National annual communication campaign organized by the French Health System authorities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with RA,
- Patient in whom the specialist physician decides to start treatment with an anti-TNF drug, regardless of the treatment line and regardless of the anti-TNF, including infliximab, adalimumab, etanercept, certolizumab and golimumab, and their respective biosimilar according to their arrival on the market
- Clinicians (hospital-based and private practice) who agree to adhere to the yearly renewal of the hospital prescription
Key exclusion criteria (1 listed)
- Patient already treated by the same anti-TNF in the past (same drug)
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 |
|---|---|---|
| sms and emails reminders6 reminders encouraging influenza vaccination on top of the National annual communication campaign organized by the French Health System authorities | Other | Reminders Group |
| No remindersno reminders on top of the National annual communication campaign organized by the French Health System authorities | Other | No reminders group |
Primary outcome
Influenza vaccination coverage
Time frame: up to 5 months
The vaccination coverage will be evaluated by comparing the vaccination coverage rate between both groups
5 secondary outcomes
Influenza vaccination coverage in the non-intervention group post Covid 19 pandemia
Time frame: up to 5 months
Factors associated with influenza non-vaccination
Time frame: up to 5 months
Reasons for influenza vaccination and non-vaccination
Time frame: up to 5 months
Covid-19 vaccination coverage including primo vaccination, booster
Time frame: up to 5 months
Adherence to national recommendations on COVID vaccination in patients with immunosuppressive treatment
Time frame: up to 5 months
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 Oct 2022.
- Derived from this study: PubMed 39576675Nguyen Y, Baron G, Hamamouche N, Belkhir R, Miconnet S, Soubrier M, Hostachy C, Thevenot P, Basch A, Truchetet ME, Claudepierre P, Dernis E, Marotte H, Flipo RM, Brocq O, Morel J, Fautrel B, Salliot C, Saraux A, Leske C, Schaeverbeke T, Ravaud P, Mariette X, Ruyssen-Witrand A, Seror R; ART Study Group section sign. Do SMS/e-mail reminders increase influenza vaccination of rheumatoid arthritis patients under anti-TNF: a nested randomized controlled trial in the ART e-cohort. Rheumatology (Oxford). 2025 May 1;64(5):2496-2504. doi: 10.1093/rheumatology/keae599.
- French National Registry - ARTLink provided by the sponsor.
- 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.
Raphaele Seror principal investigator
Hôpital Bicêtre
Adeline Ruyssen-Witrand principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sms and emails reminders and No reminders in people with Rheumatoid Arthritis, run by Societe Francaise de Rhumatologie 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 3 inclusion and 1 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 Oct 2022. 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 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?
Influenza vaccination coverage (time frame: up to 5 months). 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 NCT05220423, which also lists 1 linked publication.
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 Oct 2022.