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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).
The current phase 4 study seeks to assess the real-world injection experience, utilization, satisfaction, effectiveness, safety, and tolerability of treatment with AVT-02 (SIMLANDI™) in patients when switching from low-concentration adalimumab Humira® or another adalimumab biosimilar to high-concentration adalimumab SIMLANDI™ for the management of certain gastroenterological (IBD, including CD or UC); rheumatological (including RA, AS, or PsA); or dermatological conditions (including HS or PsO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab Reference Product to AVT-02 | Patients switching from the high-volume, low concentration, citrate containing Adalimumab reference product to the low-volume, high-concentration, citrate-free AVT-02 Adalimumab Biosimilar. |
| |
| Other Adalimumab Biosimilar to AVT-02 | Patients switching from another high-volume, low concentration, citrate-containing or citrate-free Adalimumab biosimilar product to the low-volume, high-concentration, citrate-free AVT-02 Adalimumab Biosimilar. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVT02 (Alvotech Biosimilar to Adalimumab) | Biological | Phase IV Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline injection site pain will be defined as the VAS score recorded during the last dose of the low-concentration adalimumab prior to switching to AVT-02. | At 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in injection site pain after every injection of the high-concentration adalimumab (AVT-02) as measured by VAS during the 180 days of the study. | Baseline injection site pain will be defined as the VAS score recorded during the last dose of the low-concentration adalimumab prior to switching to AVT-02. | At Every AVT-02 Injection up to 180 Days. |
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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:
Patient must be willing to keep using the same type of injector when switching from their previous adalimumab treatment to SIMLANDI™:
Access to commercial SIMLANDI™.
Patient or patient's legal/authorized representative agrees to sign informed consent and participate in the study.
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JAMP Pharma Corporation | Montreal | Quebec | J4B 5H3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41963765 | Derived | Shahrokh DK, Vender RB, Lynde CW, Rao J, Afif W, Steinhart AH, Narula N, Sutton E, Thorne C, Bessette L. Evaluation of Injection Site Pain and Adherence in Patients Transitioning from a High to Low Volume Adalimumab Formulation (AVT02, Simlandi(R)) Across Multiple Indications (EASE PAIN). Rheumatol Ther. 2026 Jun;13(3):745-765. doi: 10.1007/s40744-026-00846-1. Epub 2026 Apr 10. |
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|
| Patient perception of change in injection site pain (5-point Likert) after the first dose of high-concentration adalimumab (AVT-02) compared to Humira® or another low-concentration adalimumab biosimilar. | A five-point Likert scale of patient perception of change in injection site pain after the first dose of high-concentration adalimumab (AVT-02). | Once a month up to 180 Days. |
| Distribution of missed doses of AVT-02. | Adherence to treatment when switching from Humira® or another adalimumab biosimilar to AVT-02. | At Every AVT-02 Injection up to 180 Days. |
| Change from baseline in overall satisfaction with the injection (7-point Likert) during the 180 days of the study after switching from Humira or another low-concentration adalimumab to AVT-02. | A seven-point Likert scale of patient satisfaction. | At Every AVT-02 Injection up to 180 Days. |
| Change from baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score during the 180 days of the study after switching from Humira or another low-concentration adalimumab to AVT-02. | A questionnaire assessing health-related quality of life covering five dimensions (mobility, ability to self-care, ability to undertake usual activities, pain/discomfort, and anxiety/depression) with five levels of severity for each dimension (no problems, slight problems, moderate problems, severe problems, and extreme problems). | At days 30, 60, 90, 120, 150, and 180. |
| Change from baseline in physician disease assessment during the 180 days of the study after switching from Humira or another low-concentration adalimumab to AVT-02 | Asses the Physician Global Assessment (PGA) at baseline and at Day 180. | At Baseline and at Day 180. |
| Change from baseline in patient-reported disease assessment during the 180 days of the study after switching from Humira or another low-concentration adalimumab to AVT-02 | Asses the Patient Global Assessment of Disease Activity (PtGA) at baseline and at Day 180. | At Baseline and at Day 180. |
| Change from baseline in health care utilization during the 180 days of the study. | A questionnaire assessing healthcare resource utilization related to the patient indication, including medical events and treatments experienced by the patient in the last month. | At days 30, 60, 90, 120, 150, and 180. |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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