ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and/or remission of their disease for at least 3 months and whose physician has independently decided, within the framework of a shared medical decision, to switch them to OMLYCLO®. The primary objective of this study is to evaluate the maintenance of this control and/or clinical remission 12 months after initiation of the biosimilar, and subsequently, patient satisfaction at 6 and 12 months.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Be an adult (aged 18 years or older at the time of inclusion) receiving specialist care and diagnosed with one of the following conditions: Severe asthma, Chronic Spontaneous Urticaria
* Have been treated for at least 6 months prior to inclusion with the reference omalizumab for the relevant condition (Severe asthma or Chronic Spontaneous Urticaria).
* Have been stable for at least 3 months according to the prescribing physician, with the disease controlled or in clinical remission based on the disease-specific activity score: Severe asthma: ≤ 1 course of oral corticosteroids per year related to disease worsening, without hospitalization, and ACQ \< 1.5 and FEV1 ≥ 80% of the patient's most recent values/ Chronic Spontaneous Urticaria : UCT ≥ 12
* For whom the specialist physician has decided to switch to OMLYCLO® (biosimilar developed and marketed by Celltrion) on the day of patient inclusion (shared medical decision independent of the study).
* Be able to start treatment within a maximum of 60 days following inclusion.
* Have an email address.
* Have a mobile phone number.
* Be able to understand and complete questionnaires in French.
* Not object to participating in the study.
* Be affiliated with a French Social Security scheme or be a beneficiary of such a scheme
Exclusion Criteria:
* Patients under guardianship or trusteeship, or otherwise deprived of liberty.
* Pregnant women or women of childbearing potential with a desire to become pregnant during treatment with OMLYCLO®.
* Patients who, at the time of inclusion, are participating in a clinical trial or another clinical study that prohibits simultaneous participation in other studies.
* Contraindication to the study products.
Primary outcome measure(s)
Maintenance of disease control and/or remission 12 months after initiation of biosimilar treatment. — 12 months Patients still controlled or in clinical remission 12 months after initiation of biosimilar treatment, according to the definitions used at base
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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