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

Last updated: February 19, 2025
Sponsor: Jamp Pharma Corporation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hidradenitis Suppurativa

Arthritis And Arthritic Pain

Psoriatic Arthritis

Treatment

AVT02 (Alvotech Biosimilar to Adalimumab)

Clinical Study ID

NCT05913817
JAMP-AVT02-001
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 6months.

  3. Patient must be a current user of Humira® or another low-concentration adalimumabbiosimilar, 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 (notHumira®) 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 fromtheir 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 consentand participate in the study.

Exclusion

Exclusion Criteria:

  1. Patients previously treated with SIMLANDI™ or another high-concentration adalimumabbiosimilar.

  2. Patients that, in the opinion of the investigator, have any condition that mayimpair 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., patientswith demyelinating disorders).

  5. Patients with moderate to severe heart failure, as indicated by New York HeartAssociation (NYHA) class >= 3.

  6. Patients with severe infections such as sepsis, tuberculosis, or opportunisticinfections.

  7. Patients with history of recurrent infection or with underlying conditions which maypredispose 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 foradequate management.

  11. Active participation in or enrollment in an interventional trial.

  12. Patient or patient's legal/authorized representative cannot or will not signinformed consent.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: AVT02 (Alvotech Biosimilar to Adalimumab)
Phase:
Study Start date:
January 09, 2023
Estimated Completion Date:
May 13, 2025

Study 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).

Connect with a study center

  • JAMP Pharma Corporation

    Montréal, Quebec J4B 5H3
    Canada

    Site Not Available

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