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 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT02545868
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of RMS in accordance with the revised McDonald criteria
* Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)
* Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive
* For sexually active female participants of reproductive potential, use of reliable means of contraception
Exclusion Criteria:
* Contraindications for or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label
* Known presence of other neurologic disorders
* Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02545868
Study Brief:
Protocol Section:
NCT02545868