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Axial SpondyloarthritisMAINTAIN IINCT04925037

Explore the Associations of Behavioral Factors With Treatment Adherence in Axial Spondyloarthritis Patients Treated With Biotherapy.

An observational study of Axial Spondyloarthritis, run by University Hospital, Clermont-Ferrand at 5 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 months and older
Conditions the study is for
Axial Spondyloarthritis
What is being tested?
self-questionnaire to patients undergoing SpAax follow-up
How many people
500 participants
Where
5 sitesFrance
Study dates
21 Jun 2021to 21 Jun 2022
Phase
Observational
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 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patient with axial spondyloarthritis according to ASAS criteria and treated with biotherapy.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

Lise Laclautre contact

04 73 75 11 95

promo_interne_drci@chu-clermontferrand.fr

5 sites in 1 country

France5 sites, 5 recruiting

  • CHU Bordeaux

    Bordeaux

    Marie-Elise TRUCHETET

    Recruiting

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63000

    Lise laclautre, 04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr

    Anne TOURNADRE

    Not yet recruiting

  • CHU Limoges

    Limoges

    Pascale BERGNE-SALLE

    Recruiting

  • CHU Montpellier

    Montpellier

    Cédric LUKAS

    Recruiting

  • Chu Toulouse

    Toulouse

    Adeline RUYSSEN-WITRAND

    Recruiting

Other trials in France

About this study

Official title: Explore the Associations of Behavioral Factors With Treatment Adherence in Axial Spondyloarthritis Patients Treated With Biotherapy

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.

Read the 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)

Being tested
self-questionnaire to patients undergoing SpAax follow-up
Keywords
Adherence, Biologic treatment, Spondyloarthritis
Medical subject headings
Axial Spondyloarthritis, Spondylarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • self-questionnaire to patients undergoing SpAax follow-upBehavioural

    On the occasion of a single visit in consultation or hospitalization, an anonymous self-questionnaire will be distributed to patients undergoing SpAax follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adherence to biotherapies

    Proportion of spondyloarthritis patients with good adherence to biotherapies. Adherence was assessed by Girerd's self-administered questionnaire score.

    Six questions self-questionnaire, Yes =1 and No = 0

    Patients are then classified as follows:

    • Score = 0: Good adherence to therapy
    • Score = 1 or 2: minimal adherence problem
    • Score > 3: Poor adherence to therapy

    Measured: Day 1

Secondary outcomes (9)

  1. Proportion of patients who received influenza and pneumococcal vaccinations

    The patient checks on the self-questionnaire if he is vaccinated or not against influenza and pneumococcus

    Measured: Day 1

  2. Proportion of vaccinated patients with good adherence to biologic treatment.

    Proportion of patients who indicated to be vaccinated and who has a GIRERD score =0

    Measured: Day 1

  3. Proportion of patients using digital health tools with good adherence to biologic treatment.

    Proportion of patients who checked yes for users of digital health tools with a GIRERD score =0

    Measured: Day 1

  4. Proportion of patients on a diet and good adherence to biologic treatment.

    Proportion of patients who reported being on a diet with a GIRERD score = 0

    Measured: Day 1

  5. Proportion of Inflammatory bowel disease (IBD) patients with good adherence to biologic treatment

    Proportion of patients with crohn's disease or ulcerative colitis indicated by the physician with a GIRERD score =0

    Measured: Day 1

  6. Proportion of patients with regular physical activity and good adherence to biologic treatment.

    Proportion of patients who are physically active every day (defined by the World Health Organisation as 150 minutes per week of moderate intensity activity, or 75 minutes of high intensity activity ) and have a GIRERD score =0

    Measured: Day 1

  7. Proportion of fibromyalgia patients with good adherence to biologic treatment

    Fibromyalgia diagnosis will be evaluated by the answers to the Fibromyalgia Rapid Screening Tool self-questionnaire. 6-question closed-ended questionnaire. (YES=1, NO=0). Score ≥ 5 = Fibromyalgia confirmed.

    Proportion of patient who have a score GIRERD = 0 and FiRST score ≥ 5

    Measured: Day 1

  8. Proportions of patients with catastrophic thoughts and good adherence to biologic treatment.

    the Patient Catastrophing Scale (PCS) is a broad self report measure of pain catastrophizing and consists of 13 items scored using a 5-point Likert scales from 0 (never) to 4 (always) points. The total score for the PCS equals 52. Responses are summed to create a total score, with higher scores indicating greater pain catastrophizing levels. A score of more than 24 indicates a high level of catastrophizing.

    Measured: Day 1

  9. Proportions of patients with anxiety and depressive disorders in patients with good adherence to biologic treatment

    Anxiety and depression disorders were assessed by the Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire is composed of two parts: one part includes 7 items for screening for depression; and a second one also includes 7 items for the screening for anxiety disorders. A score between 0 and 3 is assigned to each item. The score total per party varies between 0 and 21. Score ≥ 11 = Anxiety or depression confirmed.

    Proportion of patient who has HADS-anxiety and/or HADS-depression ≥ 11 and a GIRERD score = 0.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2021
  2. Study start21 Jun 2021
  3. Primary completion21 Jun 2022 (estimated)
  4. Study completion21 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925037
Sponsor's protocol ID
RNI 2021 TOURNADRE
Acronym
MAINTAIN II
Status last verified
Mar 2022
First submitted
8 Jun 2021
Last updated
4 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Axial Spondyloarthritis, run by University Hospital, Clermont-Ferrand at 5 sites 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 2 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 Lise Laclautre (04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adherence to biotherapies (time frame: Day 1). 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 NCT04925037.

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 4 Mar 2022.

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