NCT05413759 RhEumatoid Arthritis MEDIcation Adherence
| NCT ID | NCT05413759 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-06-28 |
| Primary Completion | 2026-12-28 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2022-06-28 with a primary completion date of 2026-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rheumatoid arthritis (RA) is a public health issue because of its frequency, its functional consequences, the risk of morbidity and mortality and the costs incurred. A collaborative multiprofessional intervention initiated during hospitalization and continued after hospital discharge (ambulatory care ) would improve medication adherence in RA and therefore the health status of patients. Main objective: To compare, 12 months after the index hospitalization or consultation, the impact of pharmaceutical care provided in multiprofessional collaboration (pharmacist-physician) on medication adherence to disease-modifying treatments of patients with RA compared to usual care without pharmaceutical care and specific multi-professional collaboration. Medication adherence to disease-modifying treatments will be assessed by the rate of coverage of disease-modifying treatments (or Medication Possession Ratio (MPR)). METHODOLOGY: Interventional, multicenter, controlled, randomized, open label study, comparing in parallel 2 groups of patients with rheumatoid arthritis initially hospitalized in a rheumatology department (pharmaceutical care provided in multiprofessional collaboration (pharmacist-physician), initiated in the hospital and continued after hospital discharge (ambulatory care) vs traditional follow-up.
Eligibility Criteria
Inclusion Criteria: * Patient with diagnosed rheumatoid arthritis (RA), * Patient, male or female, aged 18 or over, * Patient hospitalized or coming for a consultation in a rheumatology department, and returned home at hospital discharge * Patient having DMARDs for RA (continuation or initiation) comprising at least methotrexate and/or a tsDMARD (targeted synthetic DMARD, JAK inhibitor) and/or subcutaneous bDMARD (biologic DMARD), * Autonomous patient in the management of his drug treatment, * Patient understanding and speaking French, * Patient affiliated to the French general national health insurance or similar, * Patient having given his free, informed and signed consent. Exclusion Criteria: * Patient whose usual pharmacy already has or has had a patient included in the INTERVENTION group in the study, * Patient whose regular pharmacy is currently treating another patient. * Patient with obvious significant cognitive or psychiatric disorders incompatible with the study (according to the judgment of the investigator), * Patient whose management of his drug treatment at home is carried out exclusively by a carer, * Patient participating in another research that may interfere (investigator's judgement) with the results of the present study, * Adult patient protected under the terms of the law (Public Health Code), * Patient not fit to carry out the follow-up, according to the judgment of the investigator, * Pregnant or breastfeeding women.
Contact & Investigator
Roland CHAPURLAT, MD/PHD
PRINCIPAL INVESTIGATOR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT05413759 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05413759 currently recruiting?
Yes, NCT05413759 is actively recruiting participants. Contact the research team at roland.charpulat@chu-lyon.fr for enrollment information.
Where is the NCT05413759 trial being conducted?
This trial is being conducted at Pierre-Bénite, France, Lyon, France.
Who is sponsoring the NCT05413759 clinical trial?
NCT05413759 is sponsored by Hospices Civils de Lyon. The principal investigator is Roland CHAPURLAT, MD/PHD at Hospices Civils de Lyon. The trial plans to enroll 200 participants.
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