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RECRUITINGOBSERVATIONAL

ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar

ROLL'YN-OMA : Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Omlyclo®, un Omalizumab Biosimilaire

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Omalizumab

omalizumab biosimilar

Locations (1)

CHU Montpellier
Montpellier, France