NCT05913817Completed
The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multiple Indications.
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 324 (actual)
- First submitted
- 2 Jun 2023
- Start date
- Jan 2023
- Primary completion date
- Jul 2025
- Lead sponsor
- Jamp Pharma Corporation
- Diseases
- Psoriasis, Crohn's disease, Ankylosing spondylitis, Ulcerative colitis, Psoriatic arthritis, Rheumatoid arthritis
- NCT number
- NCT05913817
What you commit to
- Study type: Observational
- Participants enrolled: 324
- From Jan 2023 to the primary completion date, Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously treated with SIMLANDI™ or another high-concentration adalimumab biosimilar.
- Patients for whom treatment with adalimumab may be contraindicated (e.g., patients with demyelinating disorders).
Other illness
- 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.
- Patients with moderate to severe heart failure, as indicated by New York Heart Association (NYHA) class \>= 3.
- Patients with severe infections such as sepsis, tuberculosis, or opportunistic infections.
- Patients with history of recurrent infection or with underlying conditions which may predispose them to infections.
- Patients with known hypersensitivity to SIMLANDI™ or its excipients.
Other
- Patients who are unable to secure reimbursement for SIMLANDI™.
- Patient anticipates not being available for follow-up assessments as required for adequate management.
- Active participation in or enrollment in an interventional trial.
- Patient or patient's legal/authorized representative cannot or will not sign informed consent.
Who the study is looking for
- 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™:
- Pre-filled to pre-filled switch,
- Autoinjector to autoinjector switch.
- Access to commercial SIMLANDI™.
- Patient or patient's legal/authorized representative agrees to sign informed consent and participate in the study.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| JAMP Pharma Corporation Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.