Autoimmune DiseasesNCT07221890
A Trial of Academic Detailing to Promote Prescribing of Biosimilars
A study testing Offered an academic detailing session and Standard-of-care outreach from the insurance plan in people with Autoimmune Diseases and Rheumatoid Arthritis (RA), run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Diseases, Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD)
- What is being tested?
- Offered an academic detailing session and Standard-of-care outreach from the insurance plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,325 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Nov 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Retired
- Not able to identify active clinical practice in the US (50 states plus Washington DC)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Humana Healthcare Research, Inc.
Louisville, Kentucky, 40202
About this study
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?
Read more
Researchers will compare clinicians offered the educational outreach visit to those who are not offered the visit to see if there is a difference in prescribing of biosimilar versions of adalimumab instead of the original brand-name version.
Participants will be offered the chance to meet with a trained clinician who will provide educational information tailored to their knowledge and attitudes on the topic. They will also be provided an educational brochure and patient educational materials.
Read the 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 educational module will serve as the comparison group (the control group). The study will include practices in all 50 US states and Washington, DC, and practices will be stratified into approximately 50 geographic regions. Regions containing about half of the eligible clinicians will have the module offered to the intervention group in-person and the other half of regions will have the module offered virtually. Practices will be randomized 2:1 to be offered detailing (intervention) vs. not be offered detailing (control). Outcomes, including the use and cost of biologics and biosimilars, will be measured from routinely-collected prescribing data using the Humana Research Database.
- Conditions
- Autoimmune Diseases, Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD), Psoriasis (PsO)
- Being tested
- Offered an academic detailing session, Standard-of-care outreach from the insurance plan
- Keywords
- biosimilar, biologic, academic detailing, clinician education, prescribing, Medicare Part D
- Medical subject headings
- Autoimmune Diseases, Arthritis, Rheumatoid, Inflammatory Bowel Diseases, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offered an academic detailing sessionOther
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 provide educational information about biosimilars tailored to their knowledge and attitudes on the topic. During the session, the clinician will be provided printed and/or digital materials, including an educational brochure and patient education materials. Clinicians will also receive access to a summary evidence document containing all of the material with citations. Clinicians will also be offered the opportunity to claim continuing medical education (CME) credits for participating.
Standard-of-care outreach from the insurance planOther
Clinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Offered an academic detailing session either in-person or virtually (depending on assigned geographic region), plus standard-of-care outreach from the insurance plan. Receives: Other: Offered an academic detailing session; Other: Standard-of-care outreach from the insurance plan |
| Control | Active comparator | Not offered an academic detailing session. Standard-of-care outreach from the insurance plan. Receives: Other: Standard-of-care outreach from the insurance plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of biosimilar adalimumab prescriptions per clinician
Measured: 12 months
Number of originator adalimumab (Humira) prescriptions per clinician
Measured: 12 months
Total spending (payer + patient) on adalimumab
Measured: 12 months
Patient out-of-pocket spending on adalimumab
Measured: 12 months
Secondary outcomes (4)
Number of participants in the intervention arm who participated in an educational meeting with an academic detailer
Measured: 6 months
Number of filled biosimilar prescriptions for other medications with biosimilar versions available, including ustekinumab, tocilizumab, and infliximab
Measured: 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
Measured: 12 months
Number of patients who fill 1 or more prescriptions for biosimilar adalimumab who subsequently switch back to originator biologic
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start6 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Humana Healthcare Research, Inc.
- Responsible party
- Principal investigator, Benjamin Rome, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221890
- Sponsor's protocol ID
- 2025P002143
- Status last verified
- May 2026
- First submitted
- 24 Oct 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depends on data use agreement with Humana.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Academic Detailing to Promote Prescribing of Biosimilars
- ClinicalTrials.gov ID
- NCT07221890
- Acronym / sponsor ID
- 2025P002143
- Conditions
- Autoimmune Diseases, Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD), Psoriasis (PsO)
- Keywords
- biosimilar, biologic, academic detailing, clinician education, prescribing, Medicare Part D
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,325 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Humana Healthcare Research, Inc.
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 offered the educational outreach visit to those who are not offered the visit to see if there is a difference in prescribing of biosimilar versions of adalimumab instead of the original brand-name version.
Participants will be offered the chance to meet with a trained clinician who will provide educational information tailored to their knowledge and attitudes on the topic. They will also be provided an educational brochure and patient educational materials.
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 educational module will serve as the comparison group (the control group). The study will include practices in all 50 US states and Washington, DC, and practices will be stratified into approximately 50 geographic regions. Regions containing about half of the eligible clinicians will have the module offered to the intervention group in-person and the other half of regions will have the module offered virtually. Practices will be randomized 2:1 to be offered detailing (intervention) vs. not be offered detailing (control). Outcomes, including the use and cost of biologics and biosimilars, will be measured from routinely-collected prescribing data using the Humana Research Database.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Offered an academic detailing session, Other: Standard-of-care outreach from the insurance planOffered an academic detailing session either in-person or virtually (depending on assigned geographic region), plus standard-of-care outreach from the insurance plan. |
| Control | Active comparator | Other: Standard-of-care outreach from the insurance planNot offered an academic detailing session. Standard-of-care outreach from the insurance plan. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Retired
- Not able to identify active clinical practice in the US (50 states plus Washington DC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Offered an academic detailing sessionClinicians 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 provide educational information about biosimilars tailored to their knowledge and attitudes on the topic. During the session, the clinician will be provided printed and/or digital materials, including an educational brochure and patient education materials. Clinicians will also receive access to a summary evidence document containing all of the material with citations. Clinicians will also be offered the opportunity to claim continuing medical education (CME) credits for participating. | Other | Intervention |
| Standard-of-care outreach from the insurance planClinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars. | Other | Control, Intervention |
Primary outcome
Number of biosimilar adalimumab prescriptions per clinician
Time frame: 12 months
Number of originator adalimumab (Humira) prescriptions per clinician
Time frame: 12 months
Total spending (payer + patient) on adalimumab
Time frame: 12 months
Patient out-of-pocket spending on adalimumab
Time frame: 12 months
4 secondary outcomes
Number of participants in the intervention arm who participated in an educational meeting with an academic detailer
Time frame: 6 months
Number of filled biosimilar prescriptions for other medications with biosimilar versions available, including ustekinumab, tocilizumab, and infliximab
Time frame: 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
Time frame: 12 months
Number of patients who fill 1 or more prescriptions for biosimilar adalimumab who subsequently switch back to originator biologic
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Undecided. Depends on data use agreement with Humana.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offered an academic detailing session and Standard-of-care outreach from the insurance plan in people with Autoimmune Diseases and Rheumatoid Arthritis (RA), run by Brigham and Women's Hospital at 2 sites in United States.
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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of biosimilar adalimumab prescriptions per clinician (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026.