Trial Radar AI
Clinical Trial NCT07221890 for Autoimmune Diseases, Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD), Psoriasis (PsO) is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

A Trial of Academic Detailing to Promote Prescribing of Biosimilars 1,325 Biologics Academic-Led Virtual

Active, not recruiting
Clinical Trial NCT07221890 is an interventional study for Autoimmune Diseases, Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD), Psoriasis (PsO) that is active, not recruiting. It started on November 6, 2025 with plans to enroll 1,325 participants. Led by Brigham and Women's Hospital, it is expected to complete by March 31, 2027. The latest data from ClinicalTrials.gov was last updated on December 8, 2025.
Brief Summary
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...

Show More
Detailed Description
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...Show More
Official Title

A Trial of Academic Detailing to Promote Prescribing of Biosimilars

Conditions
Autoimmune DiseasesRheumatoid Arthritis (RA)Inflammatory Bowel Disease (IBD)Psoriasis (PsO)
Other Study IDs
  • 2025P002143
NCT ID Number
NCT07221890
Start Date (Actual)
2025-11-06
Last Update Posted
2025-12-08
Completion Date (Estimated)
2027-03-31
Enrollment (Estimated)
1,325
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
biosimilar
biologic
academic detailing
clinician education
prescribing
Medicare Part D
Primary Purpose
Health Services Research
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention
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...Show More
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.
Active 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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
  • 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 logoBrigham and Women's Hospital
Humana Healthcare Research, Inc. logoHumana Healthcare Research, Inc.
Study Responsible Party
Benjamin Rome, Principal Investigator, Assistant Professor of Medicine, Brigham and Women's Hospital
No contact data.
2 Study Locations in 1 Countries

Kentucky

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

Massachusetts

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