Rheumatoid ArthritisERIBIONCT03838939
Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism
A study testing Therapeutic education in people with Rheumatoid Arthritis and Spondyloarthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The hypothesis is that group interaction associated with individual interviews intensify the acquisition of safety skills compared to individual interviews alone in patients with CIR treated by subcutaneous biotherapies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis, Spondyloarthritis
- What is being tested?
- Therapeutic education
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2019to 10 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age > 18 years old with RA (ACR/EULAR criteria) or SA (ASAS criteria) initiating a first subcutaneous biotherapy.
- Patient able to complete a questionnaire
- Patient giving informed consent.
- Patient covered by social security
Who cannot join
- - Patient with disorder of higher mental function or psychiatric disorders.
- Patient previously treated by intravenous biotherapy.
- Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Association of Individual and Group Therapeutic Education Sessions on the Acquisition of Safety Skills by Patients With Chronic Inflammatory Rheumatism (CIR) Treated With Subcutaneous Biotherapy, Compared to Individual Therapeutic Education Sessions Alone
The hypothesis is that group interaction associated with individual interviews intensify the acquisition of safety skills compared to individual interviews alone in patients with CIR treated by subcutaneous biotherapies.
Read the detailed description
Selection and inclusion of patients will be done by principal investigator of Rheumatology Department. After verification of inclusion and non-inclusion criteria by principal investigator and signature of consent, patients will be randomized by 1: 1 randomization (centralized randomization by statistician into 2 groups at M0) :
- Experimental group (individual and group therapeutic education )
- M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management".
- M3 (group with 3 to 10 patients) Intensification Biotherapy Education: Workshops : "Subcutaneous injection education" and "biotherapy management".
- M6 (individual presential or by phone) Assessment of security skills and questionnaires.
- M12 (individual presential or by phone) Assessment of security skills and questionnaires.
- Control group (individual therapeutic education alone ) :
- M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management".
- M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".
- M6 (individual présential or by phone) Assessment of security skills and questionnaires.
- M12 (individual présential or by phone) Assessment of security skills and questionnaires. Group session proposed.
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis
- Being tested
- Therapeutic education
- Keywords
- chronic inflammatory rheumatism, biotherapies, therapeutic education, safety skills
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic educationOther
Individual and group therapeutic education sessions will consist of :
- acquisition by patient of self-care skills such as performing subcutaneous injection,
- acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ...
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | M3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : "Subcutaneous injection education" and "biotherapy management Receives: Other: Therapeutic education |
| Control group | Placebo comparator | M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management". Receives: Other: Therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Biosecure's score at 6 months after biological treatment initiation
Biosecure questionnaire assesses safety skills regarding infections, vaccinations, and situations of daily life (travel, surgery, pregnancy,…). It's composed of 29 questions about knowledge and 7 scenarios. The response methods are: yes / no / I don't know, with 55 items (score from 0 to 100 points), developed by Therapeutic Education Section of French Society of Rheumatology.
Measured: at 6 months
Secondary outcomes (8)
Change from Baseline Biosecure's score at 6 months after biological treatment initiation
Biosecure questionnaire assesses safety skills regarding infections, vaccinations, and situations of daily life (travel, surgery, pregnancy,…). It's composed of 29 questions about knowledge and 7 scenarios. The response methods are: yes / no / I don't know, with 55 items (score from 0 to 100 points), developed by Therapeutic Education Section French Society of Rheumatology.
Measured: at 6 months
Number of hospitalizations for infection during the year, collected from patient (tracking book) and in medical file, at the follow-up at M12
patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician
Measured: at 12 months
Number of biotherapy stops and number of visits to physician for infection, collected from patient at M6 and M12 (tracking book)
patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician
Measured: at 6 months and 12 months
Type of infections occurring, collected from patient at M6 and M12 (tracking book )
patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician
Measured: at 6 months and 12 months
Coping evaluated by analogical visual scale at M6 and M12
RAID questionnaire is calculated according to 7 numerical rating scales: pain, functional ability, fatigue, sleep, emotional well-being, physical well-being, and disease management. Each scale is evaluated by a number between 0 and 10. A final RAID score with high values characterize a disturbing state of the patient
Measured: at 6 months and 12 months
Psychological well-being evaluated by Analogical visual scale at M6 and M12 by RAID questionnaire.
RAID questionnaire is calculated according to 7 numerical rating scales: pain, functional ability, fatigue, sleep, emotional well-being, physical well-being, and disease management. Each scale is evaluated by a number between 0 and 10. A final RAID score with high values characterize a disturbing state of the patient.
Measured: at 6 months and 12 months
Fear about treatment evaluated by FAIR questionnaire at M6 and M12.
FAIR questionnaire (Fear Assessment in Inflammatory Rheumatic diseases) evaluate the levels of fear (side effects of treatment, disease progress,…) and psychological distress in patients, it be included in clinical trial protocols to measure the impact of specific interventions on psychological distress
Measured: at 6 months and 12 months
Patient satisfaction evaluated with Patient satisfaction questionnaire
Patient satisfaction questionnaire items are: overall satisfaction of education sessions, quality of content in line with expectations, teaching methods and tools used, course flow, quality of the exchange
Measured: at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start21 Jan 2019
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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, Clermont-FerrandThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- French Society of Rheumatology
- Responsible party
- Sponsor
- Investigators
- Françoise FAYET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838939
- Sponsor's protocol ID
- CHU-420
- Other IDs
- 2018-A00647-48
- Acronym
- ERIBIO
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2019
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gossec L, Fautrel B, Flipon E, Lecoq d'Andre F, Marguerie L, Nataf H, Pallot Prades B, Piperno M, Poilverd RM, Rat AC, Sadji F, Sordet C, Thevenot C, Beauvais C. Safety of biologics: elaboration and validation of a questionnaire assessing patients' self-care safety skills: the BioSecure questionnaire. An initiative of the French Rheumatology Society Therapeutic Education section. Joint Bone Spine. 2013 Oct;80(5):471-6. doi: 10.1016/j.jbspin.2012.11.009. Epub 2013 Aug 20.
PubMed 23972274Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22.
PubMed 23875718Homer D, Nightingale P, Jobanputra P. Providing patients with information about disease-modifying anti-rheumatic drugs: Individually or in groups? A pilot randomized controlled trial comparing adherence and satisfaction. Musculoskeletal Care. 2009 Jun;7(2):78-92. doi: 10.1002/msc.141.
PubMed 18792423Koev DJ, Tankova TI, Kozlovski PG. Effect of structured group education on glycemic control and hypoglycemia in insulin-treated patients. Diabetes Care. 2003 Jan;26(1):251. doi: 10.2337/diacare.26.1.251. No abstract available.
PubMed 12502698Fayet F, Beauvais C, Pereira B, Beranger M, Rodere M, Pallot-Prades B, Peyrard P, Pouplin S, Grandjean M, Chu Miow Lin D, Ardizzone M, Cherillat MS, Tournadre A, Fan A, Soubrier M. Comparison of group versus individual patient education for promoting safety skills of patients with autoimmune rheumatic diseases treated with biologics: a multicentre randomised controlled trial. Clin Rheumatol. 2025 Jan;44(1):487-494. doi: 10.1007/s10067-024-07218-6. Epub 2024 Nov 5.
PubMed 39499437
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Association of Individual and Group Therapeutic Education Sessions on the Acquisition of Safety Skills by Patients With Chronic Inflammatory Rheumatism (CIR) Treated With Subcutaneous Biotherapy, Compared to Individual Therapeutic Education Sessions Alone
- ClinicalTrials.gov ID
- NCT03838939
- Acronym / sponsor ID
- ERIBIO / CHU-420
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis
- Keywords
- chronic inflammatory rheumatism, biotherapies, therapeutic education, safety skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- French Society of Rheumatology
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 12 Feb 2019 (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.
The hypothesis is that group interaction associated with individual interviews intensify the acquisition of safety skills compared to individual interviews alone in patients with CIR treated by subcutaneous biotherapies.
Detailed description
Selection and inclusion of patients will be done by principal investigator of Rheumatology Department. After verification of inclusion and non-inclusion criteria by principal investigator and signature of consent, patients will be randomized by 1: 1 randomization (centralized randomization by statistician into 2 groups at M0) :
- Experimental group (individual and group therapeutic education )
- M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management".
- M3 (group with 3 to 10 patients) Intensification Biotherapy Education: Workshops : "Subcutaneous injection education" and "biotherapy management".
- M6 (individual presential or by phone) Assessment of security skills and questionnaires.
- M12 (individual presential or by phone) Assessment of security skills and questionnaires.
- Control group (individual therapeutic education alone ) :
- M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management".
- M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".
- M6 (individual présential or by phone) Assessment of security skills and questionnaires.
- M12 (individual présential or by phone) Assessment of security skills and questionnaires. Group session proposed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Other: Therapeutic educationM3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : "Subcutaneous injection education" and "biotherapy management |
| Control group | Placebo comparator | Other: Therapeutic educationM3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management". |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age > 18 years old with RA (ACR/EULAR criteria) or SA (ASAS criteria) initiating a first subcutaneous biotherapy.
- Patient able to complete a questionnaire
- Patient giving informed consent.
- Patient covered by social security
Key exclusion criteria (3 listed)
- - Patient with disorder of higher mental function or psychiatric disorders.
- Patient previously treated by intravenous biotherapy.
- Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice.
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 |
|---|---|---|
| Therapeutic educationIndividual and group therapeutic education sessions will consist of : * acquisition by patient of self-care skills such as performing subcutaneous injection, * acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ... | Other | Control group, interventional group |
Primary outcome
Change from Baseline Biosecure's score at 6 months after biological treatment initiation
Time frame: at 6 months
Biosecure questionnaire assesses safety skills regarding infections, vaccinations, and situations of daily life (travel, surgery, pregnancy,…). It's composed of 29 questions about knowledge and 7 scenarios. The response methods are: yes / no / I don't know, with 55 items (score from 0 to 100 points), developed by Therapeutic Education Section of French Society of Rheumatology.
8 secondary outcomes
Change from Baseline Biosecure's score at 6 months after biological treatment initiation
Time frame: at 6 months
Number of hospitalizations for infection during the year, collected from patient (tracking book) and in medical file, at the follow-up at M12
Time frame: at 12 months
Number of biotherapy stops and number of visits to physician for infection, collected from patient at M6 and M12 (tracking book)
Time frame: at 6 months and 12 months
Type of infections occurring, collected from patient at M6 and M12 (tracking book )
Time frame: at 6 months and 12 months
Coping evaluated by analogical visual scale at M6 and M12
Time frame: at 6 months and 12 months
Psychological well-being evaluated by Analogical visual scale at M6 and M12 by RAID questionnaire.
Time frame: at 6 months and 12 months
Fear about treatment evaluated by FAIR questionnaire at M6 and M12.
Time frame: at 6 months and 12 months
Patient satisfaction evaluated with Patient satisfaction questionnaire
Time frame: at 12 month
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 10 Aug 2026.
- Background: PubMed 23972274Gossec L, Fautrel B, Flipon E, Lecoq d'Andre F, Marguerie L, Nataf H, Pallot Prades B, Piperno M, Poilverd RM, Rat AC, Sadji F, Sordet C, Thevenot C, Beauvais C. Safety of biologics: elaboration and validation of a questionnaire assessing patients' self-care safety skills: the BioSecure questionnaire. An initiative of the French Rheumatology Society Therapeutic Education section. Joint Bone Spine. 2013 Oct;80(5):471-6. doi: 10.1016/j.jbspin.2012.11.009. Epub 2013 Aug 20.
- Background: PubMed 23875718Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22.
- Background: PubMed 18792423Homer D, Nightingale P, Jobanputra P. Providing patients with information about disease-modifying anti-rheumatic drugs: Individually or in groups? A pilot randomized controlled trial comparing adherence and satisfaction. Musculoskeletal Care. 2009 Jun;7(2):78-92. doi: 10.1002/msc.141.
- Background: PubMed 12502698Koev DJ, Tankova TI, Kozlovski PG. Effect of structured group education on glycemic control and hypoglycemia in insulin-treated patients. Diabetes Care. 2003 Jan;26(1):251. doi: 10.2337/diacare.26.1.251. No abstract available.
- Results publication: PubMed 39499437Fayet F, Beauvais C, Pereira B, Beranger M, Rodere M, Pallot-Prades B, Peyrard P, Pouplin S, Grandjean M, Chu Miow Lin D, Ardizzone M, Cherillat MS, Tournadre A, Fan A, Soubrier M. Comparison of group versus individual patient education for promoting safety skills of patients with autoimmune rheumatic diseases treated with biologics: a multicentre randomised controlled trial. Clin Rheumatol. 2025 Jan;44(1):487-494. doi: 10.1007/s10067-024-07218-6. Epub 2024 Nov 5.
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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.
Françoise FAYET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic education in people with Rheumatoid Arthritis and Spondyloarthritis, run by University Hospital, Clermont-Ferrand 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 3 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 10 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
Change from Baseline Biosecure's score at 6 months after biological treatment initiation (time frame: at 6 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 NCT03838939, which also lists 5 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 10 Aug 2026.