ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
Recruiting · NCT07425639 · Observational (researchers observe without assigning treatment) · Lead sponsor: Celltrion HealthCare France
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- CHU Montpellier - Montpellier, France