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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05913817
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jamp Pharma Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis, Hidradenitis Suppurativa
Additional Details

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).

Arms & Interventions

Arms

: 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.

: 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.

Interventions

Biological: - AVT02 (Alvotech Biosimilar to Adalimumab)

Phase IV Study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

JAMP Pharma Corporation, Montréal, Quebec, Canada

Status

Recruiting

Address

JAMP Pharma Corporation

Montréal, Quebec, J4B 5H3

Site Contact

Danny Germain, M.Sc., MBA, RAC, CCPE

dgermain@jamppharma.com

438-462-7984

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