Clinical trial NCT05777902: Multidimensional Integrated Assessment to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.
Official title: Multidimensional Integrated Assessment of Neurological and Immunological Patterns to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

The primary objective of the study is to use this multidimensional integrated approach to verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration.

The endpoint that relate to this objective is to evaluate the innate immune mediated inflammation in MS patients and to correlate it with the cognitive reserve and with serum NFL levels before and after Ozanimod treatment.

Patients must meet all the following inclusion criteria to be eligible for enrolment into the study:

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;

Eligibility criteria: 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

Primary outcomes:
measure: verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRCCS Fondazione Santa Lucia
state: RM
Study officials:
References: