ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCelltrion HealthCare France
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
Adult dermatology or pulmonology patients presenting a diagnosis for any of the following pathologies: - CSU - Allergic Asthma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Omalizumab
Drugomalizumab biosimilar
Treatment groups
225 Participants
are divided into 2 treatment groupsGroup A: CSU group1 intervention
Group B: Allergic asthma group1 intervention
Trial outcomes
Primary outcomes
1
Maintenance of disease control and/or remission 12 months after initiation of biosimilar treatment.
Patients still controlled or in clinical remission 12 months after initiation of biosimilar treatment, according to the definitions used at base
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov