Clinical trial NCT04925037: Explore the Associations of Behavioral Factors With Treatment Adherence in Axial Spondyloarthritis Patients Treated With Biotherapy.
Official title: Explore the Associations of Behavioral Factors With Treatment Adherence in Axial Spondyloarthritis Patients Treated With Biotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Axial Spondyloarthritis
Keywords: Adherence
Biologic treatment
Spondyloarthritis
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with axial spondyloarthritis according to ASAS criteria and treated with biotherapy.

Brief summary: The management of chronic inflammatory rheumatism, including spondyloarthritis (SpA), has been revolutionized in recent decades with the arrival of biological therapy. The success of the current therapeutic strategy is also based on therapeutic compliance. If therapeutic adherence in rheumatoid arthritis patient (RA) is only 66%, it seems even worse in SpA. Few studies report quantitatively the adherence of SpA patients, as well as the predictive or associated factors. The objective of this study is to assess the patient adherence to biologics in patients with axial SpA (SpAax), and to investigate factors influencing this adherence, in particular the association with vaccination coverage, dietary behavior, and digital health tools.

Detailed description: Multicentric cross-sectional survey of patients seen in the context of a rheumatology consultation or hospitalization.

On the occasion of a single visit in consultation or hospitalization, an anonymous self-questionnaire will be distributed to patients undergoing SpAax follow-up to assess their compliance with biologic drugs, their vaccination coverage, their diet, the presence of a fibromyalgia syndrome or inflammatory bowel disease, intestinal disorders, regular physical activity and sedentary lifestyle, the frequency and mode of use of mobile applications and/or connected objects related to health, the presence of catastrophic thoughts and the presence of anxiety and depressive disorders. Medical data relevant to routine care will be collected.(Age, sex, weight, height, tobacco and alcohol use, disease characteristics, SpA treatment, comorbidities)

Eligibility criteria: Inclusion Criteria:

* Patient \>18 years old with axial spondyloarthritis according to ASAS criteria and treated with biotherapy.
* French-speaking, without any understanding problems.

Exclusion Criteria:

* Patients under curatorship, guardianship or other legal protection
* Patients refusing to consent to participate in research
* Pregnant and breastfeeding women.

Primary outcomes:
measure: adherence to biotherapies
timeFrame: Day 1
Secondary outcomes:
measure: Proportion of patients who received influenza and pneumococcal vaccinations
timeFrame: Day 1
measure: Proportion of vaccinated patients with good adherence to biologic treatment.
timeFrame: Day 1
measure: Proportion of patients using digital health tools with good adherence to biologic treatment.
timeFrame: Day 1
measure: Proportion of patients on a diet and good adherence to biologic treatment.
timeFrame: Day 1
measure: Proportion of Inflammatory bowel disease (IBD) patients with good adherence to biologic treatment
timeFrame: Day 1
measure: Proportion of patients with regular physical activity and good adherence to biologic treatment.
timeFrame: Day 1
measure: Proportion of fibromyalgia patients with good adherence to biologic treatment
timeFrame: Day 1
measure: Proportions of patients with catastrophic thoughts and good adherence to biologic treatment.
timeFrame: Day 1
measure: Proportions of patients with anxiety and depressive disorders in patients with good adherence to biologic treatment
timeFrame: Day 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Limoges
country: France
facility: CHU Limoges
city: Montpellier
country: France
facility: CHU Montpellier
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
References: