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New study examines pain and adherence in patients switching to concentrated adalimumab

NCT ID NCT05913817

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study involved 324 adults with conditions like Crohn's disease, arthritis, or psoriasis who switched from a standard to a higher-concentration form of adalimumab (AVT-02). Researchers measured injection site pain and how well patients stuck with their treatment over 180 days. The goal was to see if the new formulation causes less pain and improves quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

324 people

The number who actually took part.

Started

Jan 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

To ensure a representative study population, any eligible patient that meets the inclusion/exclusion criteria should be invited to participate in this non-interventional study.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient aged 18 years or older at the time of consent. 2. Patient has been diagnosed with CD, UC, RA, AS, PsA, HS, or PsO for at least 6 months. 3. Patient must be a current user of Humira® or another low-concentration adalimumab biosimilar, with treatment initiated at least 6 months prior to screening. 4. One of the following: 1. Treating physician is considering switching from Humira® to SIMLANDI™, 2. Treating physician is considering switching from an adalimumab biosimilar (not Humira®) to SIMLANDI™. 3. Treating physician has switched from Humira® or Humira® biosimilar to SIMLANDI™ within the past 3 months. 5. Patient must be willing to keep using the same type of injector when switching from their previous adalimumab treatment to SIMLANDI™: 1. Pre-filled to pre-filled switch, 2. Autoinjector to autoinjector switch. 6. Access to commercial SIMLANDI™. 7. Patient or patient's legal/authorized representative agrees to sign informed consent and participate in the study. Exclusion Criteria: 1. Patients previously treated with SIMLANDI™ or another high-concentration adalimumab biosimilar. 2. Patients that, in the opinion of the investigator, have any condition that may impair their ability to participate in the study. 3. Any current or history of any condition that, in the opinion of the investigator, participation in the study may increase the risk to the patient. 4. Patients for whom treatment with adalimumab may be contraindicated (e.g., patients with demyelinating disorders). 5. Patients with moderate to severe heart failure, as indicated by New York Heart Association (NYHA) class \>= 3. 6. Patients with severe infections such as sepsis, tuberculosis, or opportunistic infections. 7. Patients with history of recurrent infection or with underlying conditions which may predispose them to infections. 8. Patients with known hypersensitivity to SIMLANDI™ or its excipients. 9. Patients who are unable to secure reimbursement for SIMLANDI™. 10. Patient anticipates not being available for follow-up assessments as required for adequate management. 11. Active participation in or enrollment in an interventional trial. 12. Patient or patient's legal/authorized representative cannot or will not sign informed consent.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • JAMP Pharma Corporation

    Montreal, Quebec, J4B 5H3, Canada

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