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A Trial of Academic Detailing to Promote Prescribing of Biosimilars 1 325 Produits biologiques Académique Virtuel

Actif, ne recrute pas
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07221890 est une étude interventionnel pour Maladies auto-immunes, Polyarthrite Rhumatoïde (PR), Maladie inflammatoire de l'intestin (MII), Psoriasis (PsO). Son statut actuel est : actif, ne recrute pas. L'étude a débuté le 6 novembre 2025 et vise à recruter 1 325 participants. Dirigée par l'Hôpital Brigham and Women's, l'étude devrait être terminée d'ici le 31 mars 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 8 décembre 2025.
Résumé succinct
The goal of this trial is to learn if an interactive evidence-based educational outreach visits to clinicians who prescribe biologics change prescribing of biosimilar medications. The main questions it aims to answer are:

  1. Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab?
  2. Do in-person or virtual visits work better?

Researchers will compare clinicians...

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Description détaillée
This is a parallel, cluster randomized controlled trial in which medical practices with clinicians who prescribed adalimumab (Humira) to patients in a Humana Medicare Prescription Drug Plan (PDP) will be randomized to have eligible clinicians within the practice invited to participate in the educational module about biosimilars (the intervention group). Practices with eligible physicians that are not offered the educ...Afficher plus
Titre officiel

A Trial of Academic Detailing to Promote Prescribing of Biosimilars

Pathologies
Maladies auto-immunesPolyarthrite Rhumatoïde (PR)Maladie inflammatoire de l'intestin (MII)Psoriasis (PsO)
Autres identifiants de l'étude
  • 2025P002143
Numéro NCT
NCT07221890
Date de début (réel)
2025-11-06
Dernière mise à jour publiée
2025-12-08
Date de fin (estimée)
2027-03-31
Inscription (estimée)
1 325
Type d'étude
Interventionnel
PHASE
N/A
Statut
Actif, ne recrute pas
Mots clés
biosimilar
biologic
academic detailing
clinician education
prescribing
Medicare Part D
Objectif principal
Recherche sur les services de santé
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalIntervention
Offered an academic detailing session either in-person or virtually (depending on assigned geographic region), plus standard-of-care outreach from the insurance plan.
Offered an academic detailing session
Clinicians will be offered an academic detailing session that will be delivered by a specially trained pharmacist, nurse, or physician (i.e., detailer). These academic detailers will be provided and trained by an independent non-profit organization. After a clinician agrees to participate in an academic detailing session, the detailer will schedule a 1-on-1 meeting lasting 15-20 minutes during which the detailer will...Afficher plus
Standard-of-care outreach from the insurance plan
Clinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars.
Comparateur actifControl
Not offered an academic detailing session. Standard-of-care outreach from the insurance plan.
Standard-of-care outreach from the insurance plan
Clinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Number of biosimilar adalimumab prescriptions per clinician
12 months
Number of originator adalimumab (Humira) prescriptions per clinician
12 months
Total spending (payer + patient) on adalimumab
12 months
Patient out-of-pocket spending on adalimumab
12 months
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Number of participants in the intervention arm who participated in an educational meeting with an academic detailer
6 months
Number of filled biosimilar prescriptions for other medications with biosimilar versions available, including ustekinumab, tocilizumab, and infliximab
12 months
Number of filled prescriptions for other brand-name disease-modifying medications that are FDA approved to treat 1 or more of the same indications as adalimumab, such as TNF-alpha inhibitors and interleukin inhibitors
12 months
Number of patients who fill 1 or more prescriptions for biosimilar adalimumab who subsequently switch back to originator biologic
12 months
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Sexes éligibles
Tous
  • Wrote 7 or more adalimumab prescriptions that were filled by patients enrolled in research-eligible Humana Medicare Part D plans in the calendar year 2025

  • Retired
  • Not able to identify active clinical practice in the US (50 states plus Washington DC)
Brigham and Women's Hospital logoHôpital Brigham and Women's
Humana Healthcare Research, Inc. logoHumana Healthcare Research, Inc.
Partie responsable de l'étude
Benjamin Rome, Investigateur principal, Assistant Professor of Medicine, Brigham and Women's Hospital
Aucune donnée de contact disponible
2 Centres de l'étude dans 1 pays

Kentucky

Humana Healthcare Research, Inc., Louisville, Kentucky, 40202, United States

Massachusetts

Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States