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

NCT05913817 | Completed DMC

• 1 other identifier: JAMP-AVT02-001
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 1

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).

Conditions

Crohn Disease; Ulcerative Colitis; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Plaque Psoriasis; Hidradenitis Suppurativa

Keywords

Injection Site Pain

Outcome Measures

Primary Outcomes (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).

  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 Outcomes (8)

• 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.

• 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.

• Distribution of missed doses of 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.

  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.

  At days 30, 60, 90, 120, 150, and 180.

Study Arms (2)

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)

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)

Interventions

AVT02 (Alvotech Biosimilar to Adalimumab) BIOLOGICAL

Phase IV Study

Also known as: Humira

Adalimumab Reference Product to AVT-02; Other Adalimumab Biosimilar to AVT-02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient aged 18 years or older at the time of consent.
• Patient has been diagnosed with CD, UC, RA, AS, PsA, HS, or PsO for at least 6 months.
• Patient must be a current user of Humira® or another low-concentration adalimumab biosimilar, with treatment initiated at least 6 months prior to screening.
• One of the following:
• Treating physician is considering switching from Humira® to SIMLANDI™,
• Treating physician is considering switching from an adalimumab biosimilar (not Humira®) to SIMLANDI™.
• Treating physician has switched from Humira® or Humira® biosimilar to SIMLANDI™ within the past 3 months.
• Patient must be willing to keep using the same type of injector when switching from their previous adalimumab treatment to SIMLANDI™:
• Pre-filled to pre-filled switch,
• Autoinjector to autoinjector switch.
• Access to commercial SIMLANDI™.
• Patient or patient's legal/authorized representative agrees to sign informed consent and participate in the study.

You may not qualify if:

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

Sponsors & Collaborators

• Jamp Pharma Corporation: lead

Study Sites (1)

JAMP Pharma Corporation

Montreal, Quebec, J4B 5H3, Canada

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Hidradenitis Suppurativa

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 22, 2023
• Study Start: January 9, 2023
• Primary Completion: July 31, 2025
• Study Completion: August 25, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)