The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Conc… (NCT05913817) | Clinical Trial Compass
CompletedNot Applicable
The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multiple Indications.
Canada324 participantsStarted 2023-01-09
Plain-language summary
The purpose of the Phase IV study is to investigate the effects of both Volume and Citrate on Injection Site Pain (ISP), adherence, patient satisfaction, Quality of Life, and Disease Assessment in the Canadian Adalimumab Market.
The phase IV study is an observational, pan-Canadian, multidisciplinary study aiming to enroll 600 patients across 50-70 sites across 3 different Therapeutic Areas (GI, Rheum, Derm).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient aged 18 years or older at the time of consent.
✓. Patient has been diagnosed with CD, UC, RA, AS, PsA, HS, or PsO for at least 6 months.
✓. Patient must be a current user of Humira® or another low-concentration adalimumab biosimilar, with treatment initiated at least 6 months prior to screening.
✓. One of the following:
✓. Treating physician is considering switching from Humira® to SIMLANDI™,
✓. Treating physician is considering switching from an adalimumab biosimilar (not Humira®) to SIMLANDI™.
✓. Treating physician has switched from Humira® or Humira® biosimilar to SIMLANDI™ within the past 3 months.
✓. Patient must be willing to keep using the same type of injector when switching from their previous adalimumab treatment to SIMLANDI™:
Exclusion criteria
✕. Patients previously treated with SIMLANDI™ or another high-concentration adalimumab biosimilar.
✕. Patients that, in the opinion of the investigator, have any condition that may impair their ability to participate in the study.
✕. 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.
✕
What they're measuring
1
Change from baseline in injection site pain after the first dose of high-concentration adalimumab (AVT-02) as measured by the Visual Analog Scale (VAS); 2 weeks after Humira Injection (can be 1 week for certain indications such as HS).