Phase
Condition
Hidradenitis Suppurativa
Arthritis And Arthritic Pain
Psoriatic Arthritis
Treatment
AVT02 (Alvotech Biosimilar to Adalimumab)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 6months.
Patient must be a current user of Humira® or another low-concentration adalimumabbiosimilar, 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 (notHumira®) 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 fromtheir 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 consentand participate in the study.
Exclusion
Exclusion Criteria:
Patients previously treated with SIMLANDI™ or another high-concentration adalimumabbiosimilar.
Patients that, in the opinion of the investigator, have any condition that mayimpair 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., patientswith demyelinating disorders).
Patients with moderate to severe heart failure, as indicated by New York HeartAssociation (NYHA) class >= 3.
Patients with severe infections such as sepsis, tuberculosis, or opportunisticinfections.
Patients with history of recurrent infection or with underlying conditions which maypredispose 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 foradequate management.
Active participation in or enrollment in an interventional trial.
Patient or patient's legal/authorized representative cannot or will not signinformed consent.
Study Design
Study Description
Connect with a study center
JAMP Pharma Corporation
Montréal, Quebec J4B 5H3
CanadaSite Not Available
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