Rheumatoid ArthritisBIOSIMINFONCT04321291
Information and Acceptability of Biosimilars
A study testing Generic information leaflet and Individual information by nurse on biosimilars in people with Rheumatoid Arthritis and Spondyloarthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Patients with rheumatoid arthritis or spondyloarthritis, currently treated or about to be started with anti-TNF original drug adalimumab or etanercept will be included and randomized to either " information leaflet only " or " information leaflet + nurse information " arms, just before they see their rheumatologist… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis
- What is being tested?
- Generic information leaflet and Individual information by nurse on biosimilars
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2020to Nov 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and over (no upper age limit)
- All adult patients seen in rheumatology consultation at the Montpellier Hospital
- With inflammatory rheumatism (rheumatoid arthritis or spondyloarthritis).
- Treated (or in the process of being treated at the end of the consultation) by etanercept or adalimumab
- In whom the biomedical treatment already used should in principle be renewed without modification (patient deemed good responder and well tolerant of the treatment)
- Or where biomedical initiation has just been indicated during the consultation
- Member of a social security scheme
- Informed and written consent
Who cannot join
- Unable to understand information (not fluent in the French language, severe cognitive impairment, etc.)
- Known intolerance to one of the proposed biosimilar excipients
- Vulnerable persons: pregnant woman, minor patient, deprived of liberty, under guardianship or under curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU, Service Immuno-rhumatologie, Département de rhumatologie
Montpellier
About this study
Official title: Impact of a Nurse's Specific Information on the Acceptability of Biosimilars in Chronic Inflammatory Rheumatism
Patients with rheumatoid arthritis or spondyloarthritis, currently treated or about to be started with anti-TNF original drug adalimumab or etanercept will be included and randomized to either " information leaflet only " or " information leaflet + nurse information " arms, just before they see their rheumatologist for periodic assessment of disease and treatment.
Patients from the " information leaflet only " arm will be distributed individually a dedicated leaflet with written generic informations about the use of biosimilars in rheumatic diseases (individual and societal advantages, pharmaceutical development, scientific efficacy and safety results).
Read more
Patients from the " " information leaflet + nurse information " arm will be delivered the same leaflet, and additionally offered to have a dedicated individual interview with a specialist nurse, who will orally discuss informations about biosimilars based on a standardized talk, completed by answers to any questions by the patient.
The rheumatologist will then propose, unless inappropriate based on clinical evaluation of the patient, a change in the treatment of patients from the original drug to the corresponding biosimilar.
The primary outcome will be the observed proportions of patients actually receiving the biosimilar drug at the 6-months follow-up visit in the 2 compared arms.
Secondary outcomes will be average time spent by the nurse to adequatley inform the patient, the proportion of patients from the intervention arm who have actually asked for the nurse information interview, and the reasons for refusal of biosimilars, when appropriate.
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis
- Being tested
- Generic information leaflet, Individual information by nurse on biosimilars
- Keywords
- Rheumatoid arthritis, Spondyloarthritis, Biologics, Biosimilars information
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic information leafletOther
The information about the biosimiliars is realized only by the transmission of the information leaflet in addition to the information given by the investigator.
Individual information by nurse on biosimilarsOther
Delivery of the same information leaflet, completed if asked by the patient, by individual meeting with specialist nurse, including generic and standardized informations on specificities, advantages and current scientific knowledge about biosimilars in inflammatory rheumatic diseases. This is in addition to the information given by the investigator
| Study group | Role | What they receive |
|---|---|---|
| Nurse information | Experimental | The patient will receive a generic information leaflet plus an Individual information by nurse on biosimilars Receives: Other: Individual information by nurse on biosimilars |
| Information Leaflet | Other | The patient will receive a generic information leaflet only Receives: Other: Generic information leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed rate of prescribed biosimilars
The measure is the number of patient who accept the biosimilars
Measured: 18 months
Secondary outcomes (3)
Average time spent by nurse to inform patients
the measure is done by the completion of a questionnaire by the nurse who report the time spent with the patient
Measured: 18 months
Proportion of patients from the intervention arm having actually received specific information by nurse
Verify the number of patient who receive the information thanks to the nurse questionnaire
Measured: 18 months
Reasons for refusal of biosimilars
The measure is done by the completion of a questionnaire by the patient
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start2 Jul 2020
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric LUKAS, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321291
- Sponsor's protocol ID
- RECHMPL19_0084
- Acronym
- BIOSIMINFO
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2020
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Nurse's Specific Information on the Acceptability of Biosimilars in Chronic Inflammatory Rheumatism
- ClinicalTrials.gov ID
- NCT04321291
- Acronym / sponsor ID
- BIOSIMINFO / RECHMPL19_0084
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis
- Keywords
- Rheumatoid arthritis, Spondyloarthritis, Biologics, Biosimilars information
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 25 Mar 2020 (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.
Patients with rheumatoid arthritis or spondyloarthritis, currently treated or about to be started with anti-TNF original drug adalimumab or etanercept will be included and randomized to either " information leaflet only " or " information leaflet + nurse information " arms, just before they see their rheumatologist for periodic assessment of disease and treatment.
Patients from the " information leaflet only " arm will be distributed individually a dedicated leaflet with written generic informations about the use of biosimilars in rheumatic diseases (individual and societal advantages, pharmaceutical development, scientific efficacy and safety results).
Patients from the " " information leaflet + nurse information " arm will be delivered the same leaflet, and additionally offered to have a dedicated individual interview with a specialist nurse, who will orally discuss informations about biosimilars based on a standardized talk, completed by answers to any questions by the patient.
The rheumatologist will then propose, unless inappropriate based on clinical evaluation of the patient, a change in the treatment of patients from the original drug to the corresponding biosimilar.
The primary outcome will be the observed proportions of patients actually receiving the biosimilar drug at the 6-months follow-up visit in the 2 compared arms.
Secondary outcomes will be average time spent by the nurse to adequatley inform the patient, the proportion of patients from the intervention arm who have actually asked for the nurse information interview, and the reasons for refusal of biosimilars, when appropriate.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse information | Experimental | Other: Individual information by nurse on biosimilarsThe patient will receive a generic information leaflet plus an Individual information by nurse on biosimilars |
| Information Leaflet | Other | Other: Generic information leafletThe patient will receive a generic information leaflet only |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 and over (no upper age limit)
- All adult patients seen in rheumatology consultation at the Montpellier Hospital
- With inflammatory rheumatism (rheumatoid arthritis or spondyloarthritis).
- Treated (or in the process of being treated at the end of the consultation) by etanercept or adalimumab
- In whom the biomedical treatment already used should in principle be renewed without modification (patient deemed good responder and well tolerant of the treatment)
Key exclusion criteria (3 listed)
- Unable to understand information (not fluent in the French language, severe cognitive impairment, etc.)
- Known intolerance to one of the proposed biosimilar excipients
- Vulnerable persons: pregnant woman, minor patient, deprived of liberty, under guardianship or under curatorship
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 |
|---|---|---|
| Generic information leafletThe information about the biosimiliars is realized only by the transmission of the information leaflet in addition to the information given by the investigator. | Other | Information Leaflet |
| Individual information by nurse on biosimilarsDelivery of the same information leaflet, completed if asked by the patient, by individual meeting with specialist nurse, including generic and standardized informations on specificities, advantages and current scientific knowledge about biosimilars in inflammatory rheumatic diseases. This is in addition to the information given by the investigator | Other | Nurse information |
Primary outcome
Observed rate of prescribed biosimilars
Time frame: 18 months
The measure is the number of patient who accept the biosimilars
3 secondary outcomes
Average time spent by nurse to inform patients
Time frame: 18 months
Proportion of patients from the intervention arm having actually received specific information by nurse
Time frame: 18 months
Reasons for refusal of biosimilars
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- 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.
Cédric LUKAS principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generic information leaflet and Individual information by nurse on biosimilars in people with Rheumatoid Arthritis and Spondyloarthritis, 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 8 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: status not confirmed, as of the sponsor's last update on 6 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cédric LUKAS (467335651 ext. +33, c-lukas@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed rate of prescribed biosimilars (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2023.