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 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT03961204
Eligibility Criteria:
Inclusion Criteria:
* Participants with relapsing remitting multiple sclerosis (RRMS) randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received greater than or equal to (\>=) 1 course of in investigational medicinal product (IMP) Cladribine Tablets or placebo
* Participants with their first clinical demyelinating event randomised in ORACLE MS clinical trial who have received \>= 1 course of IMP Cladribine Tablets or placebo
* Participants who has sign informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol
Exclusion Criteria:
* Participants who has any uncontrolled disease state other than MS, that in the Investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
* For study participants at selected sites where MRI assessment will be conducted following exclusion criteria will apply to MRI assessments only:
* Female study participants who are pregnant
* Participants who are taking Cladribine Tablets as part of another study at the time of the start of this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03961204
Study Brief:
Protocol Section:
NCT03961204