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

March 13, 2026 updated by: Jamp Pharma Corporation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, J4B 5H3
        • JAMP Pharma Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  1. Patient aged 18 years or older at the time of consent.
  2. Patient has been diagnosed with CD, UC, RA, AS, PsA, HS, or PsO for at least 6 months.
  3. Patient must be a current user of Humira® or another low-concentration adalimumab biosimilar, with treatment initiated at least 6 months prior to screening.

  4. One of the following:

    1. Treating physician is considering switching from Humira® to SIMLANDI™,
    2. Treating physician is considering switching from an adalimumab biosimilar (not Humira®) to SIMLANDI™.
    3. Treating physician has switched from Humira® or Humira® biosimilar to SIMLANDI™ within the past 3 months.

  5. Patient must be willing to keep using the same type of injector when switching from their previous adalimumab treatment to SIMLANDI™:

    1. Pre-filled to pre-filled switch,
    2. Autoinjector to autoinjector switch.
  6. Access to commercial SIMLANDI™.
  7. Patient or patient's legal/authorized representative agrees to sign informed consent and participate in the study.

Exclusion Criteria:

  1. Patients previously treated with SIMLANDI™ or another high-concentration adalimumab biosimilar.
  2. Patients that, in the opinion of the investigator, have any condition that may impair their ability to participate in the study.
  3. 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.
  4. Patients for whom treatment with adalimumab may be contraindicated (e.g., patients with demyelinating disorders).
  5. Patients with moderate to severe heart failure, as indicated by New York Heart Association (NYHA) class >= 3.
  6. Patients with severe infections such as sepsis, tuberculosis, or opportunistic infections.
  7. Patients with history of recurrent infection or with underlying conditions which may predispose them to infections.
  8. Patients with known hypersensitivity to SIMLANDI™ or its excipients.
  9. Patients who are unable to secure reimbursement for SIMLANDI™.
  10. Patient anticipates not being available for follow-up assessments as required for adequate management.
  11. Active participation in or enrollment in an interventional trial.
  12. Patient or patient's legal/authorized representative cannot or will not sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: AVT02 (Alvotech Biosimilar to Adalimumab)
Phase IV Study
Other Names:
  • Humira
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.
Biological: AVT02 (Alvotech Biosimilar to Adalimumab)
Phase IV Study
Other Names:
  • Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).
Time Frame: At 2 Weeks
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

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: At Every AVT-02 Injection up to 180 Days.
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.
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.
Time Frame: Once a month up to 180 Days.
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.
Time Frame: At Every AVT-02 Injection up to 180 Days.
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.
Time Frame: At Every AVT-02 Injection up to 180 Days.
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.
Time Frame: At days 30, 60, 90, 120, 150, and 180.
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
Time Frame: At Baseline and at Day 180.
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
Time Frame: At Baseline and at Day 180.
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.
Time Frame: At days 30, 60, 90, 120, 150, and 180.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jamp Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

August 25, 2025

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JAMP-AVT02-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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