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

NCT ID: NCT05913817

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2025-05-13

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).

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

AVT02 (Alvotech Biosimilar to Adalimumab)

Intervention Type: BIOLOGICAL

Phase IV Study

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.

AVT02 (Alvotech Biosimilar to Adalimumab)

Intervention Type: BIOLOGICAL

Phase IV Study

Interventions

AVT02 (Alvotech Biosimilar to Adalimumab)

Phase IV Study

Intervention Type: BIOLOGICAL

Other Intervention Names

Humira

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jamp Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

JAMP Pharma Corporation

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

JAMP-AVT02-001

Identifier Type: -

Identifier Source: org_study_id