New study examines pain and adherence in patients switching to concentrated adalimumab
NCT ID NCT05913817
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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324 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Aug 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide 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
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JAMP Pharma Corporation
Montreal, Quebec, J4B 5H3, Canada
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