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De klinische studie NCT07221890 voor Auto-immuunziekten, Reumatoïde Artritis (RA), Inflammatoire darmziekte (IBD), Psoriasis (PsO) is actief, niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
A Trial of Academic Detailing to Promote Prescribing of Biosimilars 1.325 Biologics Academisch Virtueel
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De klinische studie NCT07221890 is een interventioneel studie bij Auto-immuunziekten, Reumatoïde Artritis (RA), Inflammatoire darmziekte (IBD), Psoriasis (PsO) met de status actief, niet rekruterend. Het doel is om 1.325 deelnemers te includeren vanaf 6 november 2025. De studie wordt geleid door Brigham and Women's Hospital en de voltooiing is gepland op 31 maart 2027. Laatste update op ClinicalTrials.gov: 8 december 2025.
Beknopte samenvatting
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:
- Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab?
- Do in-person or virtual visits work better?
Researchers will compare clinicians...
Toon meerUitgebreide beschrijving
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...Toon meer
Officiële titel
A Trial of Academic Detailing to Promote Prescribing of Biosimilars
Aandoeningen
Auto-immuunziektenReumatoïde Artritis (RA)Inflammatoire darmziekte (IBD)Psoriasis (PsO)Andere studie-ID's
- 2025P002143
NCT-ID
Startdatum (Werkelijk)
2025-11-06
Laatste update geplaatst
2025-12-08
Verwachte einddatum
2027-03-31
Inschrijving (Geschat)
1.325
Studietype
Interventioneel
FASE
N.v.t.
Status
Actief, niet rekruterend
Trefwoorden
biosimilar
biologic
academic detailing
clinician education
prescribing
Medicare Part D
biologic
academic detailing
clinician education
prescribing
Medicare Part D
Primaire doel
Onderzoek naar gezondheidsdiensten
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelIntervention 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...Toon meer 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. |
Actieve comparatorControl 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. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind, Volwassene, Oudere volwassene
Geslachten die in aanmerking komen voor de studie
Allen
- 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)
Verantwoordelijke instantie
Benjamin Rome, Hoofdonderzoeker, Assistant Professor of Medicine, Brigham and Women's Hospital
Geen contactgegevens beschikbaar
2 Studielocaties in 1 landen
Kentucky
Humana Healthcare Research, Inc., Louisville, Kentucky, 40202, United States
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States