EASE PAIN: 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 (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05913817
Collaborator
(none)
600
1
22.1
27.1

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Biological: AVT02 (Alvotech Biosimilar to Adalimumab)

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 Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multiple Indications.
Actual Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Sep 18, 2024
Anticipated Study Completion Date :
Nov 13, 2024

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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). [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.

    Secondary Outcome Measures

    1. 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. [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.

    2. 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. [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).

    3. Distribution of missed doses of AVT-02. [At Every AVT-02 Injection up to 180 Days.]

      Adherence to treatment when switching from Humira® or another adalimumab biosimilar to AVT-02.

    4. 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. [At Every AVT-02 Injection up to 180 Days.]

      A seven-point Likert scale of patient satisfaction.

    5. 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. [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).

    6. 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 [At Baseline and at Day 180.]

      Asses the Physician Global Assessment (PGA) at baseline and at Day 180.

    7. 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 [At Baseline and at Day 180.]

      Asses the Patient Global Assessment of Disease Activity (PtGA) at baseline and at Day 180.

    8. Change from baseline in health care utilization during the 180 days of the study. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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:

    5. Treating physician is considering switching from Humira® to SIMLANDI™,

    6. Treating physician is considering switching from an adalimumab biosimilar (not Humira®) to SIMLANDI™.

    7. Treating physician has switched from Humira® or Humira® biosimilar to SIMLANDI™ within the past 3 months.

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

    9. Pre-filled to pre-filled switch,

    10. Autoinjector to autoinjector switch.

    11. Access to commercial SIMLANDI™.

    12. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 JAMP Pharma Corporation Montréal Quebec Canada J4B 5H3

    Sponsors and Collaborators

    • Jamp Pharma Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jamp Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT05913817
    Other Study ID Numbers:
    • JAMP-AVT02-001
    First Posted:
    Jun 22, 2023
    Last Update Posted:
    Jun 22, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jamp Pharma Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 22, 2023