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

Sponsor
Jamp Pharma Corporation
Study ID
NCT05913817
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Jan 9, 2023
Status verified
Mar 2026
Primary completion
Jul 31, 2025
Completion
Aug 25, 2025

Study Design

Enrollment
324 participants (actual)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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). [ Time Frame: At 2 Weeks ]

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