Non-radiographic SpondyloarthritisALSASPNCT03360864
Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment
A study testing Education program in people with Non-radiographic Spondyloarthritis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
To describe, with a patient reported score (BIOSECURE), the influence of an approved therapeutic education program (TEP) in patients with joint inflammation requiring a biological treatment initiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-radiographic Spondyloarthritis
- What is being tested?
- Education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2020to 16 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-radiological spondyloarthritis diagnosis (ASAS criteria)
- Anti-TNFalpha biological treatment initiation required
- Adult patient (age>18years)
- Capacity to understand self-questionnaires and address questions
- Patient accepting to attend a therapeutic education program (TEP)
Who cannot join
- Previous Anti-TNFalpha biological treatment
- Previous attendance to a TEP concerning biological or spondyloarthritis
- Contraindication to Anti-TNFalpha treatment
- Associated and unbalanced diseases
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Christelle SORDET, MD, 3 88 12 81 16 ext. +33, christelle.sordet@chru-strasbourg.fr
About this study
Official title: Impact of a Therapeutic Education Program in Patients With Non-radiological Spondyloarthritis Treated With Anti-tumor Necrosis Factor (TNF)
To describe, with a patient reported score (BIOSECURE), the influence of an approved therapeutic education program (TEP) in patients with joint inflammation requiring a biological treatment initiation.
The hypothesis is that patients attending the TEP will display better cognitive and adaptation competences than patients with no TEP.
Patient's reported quality of life, disease related stress management, treatment adherence, socio-demographic factors, biological home administration modalities and if the biologic treatment is maintained at 12 months, will also be described.
- Conditions
- Non-radiographic Spondyloarthritis
- Being tested
- Education program
- Keywords
- Therapeutic education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education programOther
Patient will participate to a education program.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Education Program | Experimental | Patient randomized in this arm will attend a 1 day long validated Therapeutic Education Program.
This program will take place within 6 months after biologic treatment initiation. Receives: Other: Education program |
| No therapeutic Education Program | No intervention | Patient randomized in this arm will not attend a Therapeutic Education Program within 12 months after biologic treatment initiation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIOSECURE patient self-questionnaire
Patients will address questions and role play scenario evaluating cognitive and adaptive competences. The Biosecure score is between 0 and 100.
Measured: Change from Baseline Biosecure's score at 6 months and at 12 month after biological treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start16 Jan 2020
- Primary completion16 Jan 2022 (estimated)
- Study completion16 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-radiographic SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle SORDET, MD, Principal investigator, CHU de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360864
- Sponsor's protocol ID
- 6661
- Acronym
- ALSASP
- Status last verified
- Oct 2020
- First submitted
- 27 Nov 2017
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Therapeutic Education Program in Patients With Non-radiological Spondyloarthritis Treated With Anti-tumor Necrosis Factor (TNF)
- ClinicalTrials.gov ID
- NCT03360864
- Acronym / sponsor ID
- ALSASP / 6661
- Conditions
- Non-radiographic Spondyloarthritis
- Keywords
- Therapeutic education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 16 Jan 2022 (estimated)
- Study completion
- 16 Jan 2023 (estimated)
- First posted
- 4 Dec 2017 (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.
To describe, with a patient reported score (BIOSECURE), the influence of an approved therapeutic education program (TEP) in patients with joint inflammation requiring a biological treatment initiation.
The hypothesis is that patients attending the TEP will display better cognitive and adaptation competences than patients with no TEP.
Patient's reported quality of life, disease related stress management, treatment adherence, socio-demographic factors, biological home administration modalities and if the biologic treatment is maintained at 12 months, will also be described.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Education Program | Experimental | Other: Education programPatient randomized in this arm will attend a 1 day long validated Therapeutic Education Program. This program will take place within 6 months after biologic treatment initiation. |
| No therapeutic Education Program | No intervention | –Patient randomized in this arm will not attend a Therapeutic Education Program within 12 months after biologic treatment initiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-radiological spondyloarthritis diagnosis (ASAS criteria)
- Anti-TNFalpha biological treatment initiation required
- Adult patient (age>18years)
- Capacity to understand self-questionnaires and address questions
- Patient accepting to attend a therapeutic education program (TEP)
Key exclusion criteria (4 listed)
- Previous Anti-TNFalpha biological treatment
- Previous attendance to a TEP concerning biological or spondyloarthritis
- Contraindication to Anti-TNFalpha treatment
- Associated and unbalanced diseases
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 |
|---|---|---|
| Education programPatient will participate to a education program. | Other | Therapeutic Education Program |
Primary outcome
BIOSECURE patient self-questionnaire
Time frame: Change from Baseline Biosecure's score at 6 months and at 12 month after biological treatment initiation
Patients will address questions and role play scenario evaluating cognitive and adaptive competences. The Biosecure score is between 0 and 100.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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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.
Christelle SORDET, MD principal investigator
CHU de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education program in people with Non-radiographic Spondyloarthritis, run by University Hospital, Strasbourg, France 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 5 inclusion and 4 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 27 Oct 2020. 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 Christelle SORDET, MD (3 88 12 81 16 ext. +33, christelle.sordet@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIOSECURE patient self-questionnaire (time frame: Change from Baseline Biosecure's score at 6 months and at 12 month after biological treatment initiation). 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 27 Oct 2020.