Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT05123703
Eligibility Criteria:
Inclusion Criteria:
* Body weight ≥ 25 kilograms (kg)
* Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric Multiple Sclerosis (MS), Version 2012, or McDonald criteria 2017
* Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive
* For all countries except Germany, at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 months
Inclusion Criteria for Optional OLE Period:
-Participants in Group A (ocrelizumab in the double-blind period \[DBP\]) and Group B (fingolimod in the DBP) who, in the opinion of the investigator, may benefit from switching to ocrelizumab and who have completed the DBP with study treatment (ocrelizumab/fingolimod), may participate in the OLE period
Exclusion Criteria:
* Known presence or suspicion of other neurologic disorders that may mimic MS
* Significant uncontrolled somatic diseases, known active infection or any other significant condition that may preclude participant from participating in the study
* Participants with severe cardiac disease or significant findings on the screening Electrocardiograph (ECG)
Exclusion Criteria for Optional OLE Period:
-Participants who have discontinued the study during the DBP
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT05123703
Study Brief:
Protocol Section:
NCT05123703