OMNIAOMS
What it found
The trial ended early for another reason (see below).
Reason given: Sponsor's decision
This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Ozanimod
Sphingosine 1-phosphate receptor 5 modulator
What it measured
Main measures
verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration.
12 months
Blood or spinal fluid markersThinking and memoryTo evaluate the innate immune mediated inflammation in MS patients and to
Other measures (1)
To observe the effect of Ozanimod on innate and adaptive immune cells in terms of
Immune response
Who could take part
Relapsing MS · 18 to 45
Inclusion Criteria: * 1) Diagnosis of MS accordingly to 2017 revised McDonald criteria; 2) Patients candidate to receive Ozanimod therapy (disease characteristics, EDSS, age, lifestyle, disease progression, etc.); 3) Age between 18 and 45 years; 4) EDSS score from 0 to 4; 5) Signature and date of written ICF prior to entering the study; Exclusion Criteria: * The presence of any of the following will exclude a patient from study enrolment: 1. Ongoing immunomodulatory or immunosuppressive treatment; 2. Other autoimmune comorbidities (i.e. antiphospolipid syndrome); 3. Treatment with steroids in the last 30 days before enrollment; 4. Acute inflammatory status not MS related (i.e. bacterial or viral infections) in the previous 30 days; 5. Patients unable to read and understand the documents of the study. 6. Participation in any interventional clinical trials or compassionate use programs 7. Contraindications and "not-recommendations" reported in SmP
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a prospective interventional study with a 12-month follow-up of patients diagnosed with Multiple Sclerosis. Enrollment includes patients for whom Ozanimod will be prescribed based on regular clinical practice. It is proposed to integrate the measurements obtained using multiple instruments, with the aim of analyzing the immunological landscape, connectivity networks and anatomical traits of neurodegeneration. Patients will return for imaging and noninvasive electrophysiological studies 3, 6, and 12 months after initiation of therapy. On the same day, blood samples will be taken and immunological and biochemical tests will be performed.
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History
Started
Jan 2023
Main results due
Apr 2024
Finished
Apr 2024
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