NCT05913817

The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multiple Indications.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 324 (actual)
• Sponsor: Jamp Pharma Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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).

Detailed description

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).

Conditions

• Crohn Disease
• Ulcerative Colitis
• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Plaque Psoriasis
• Hidradenitis Suppurativa

Interventions

Type	Name	Description
BIOLOGICAL	AVT02 (Alvotech Biosimilar to Adalimumab)	Phase IV Study

Timeline

• Start date: 2023-01-09
• Primary completion: 2025-07-31
• Completion: 2025-08-25
• First posted: 2023-06-22
• Last updated: 2026-03-17

Locations

1 site across 1 country: Canada