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 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT01621269
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects aged 18-65 years
* Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
* Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
* Interferon-beta (IFN-β) treatment for at least 18 months.
* Positive IFN-NAb titer at screening or within 6 months prior to screening
* Patients with disease activity despite treatment with IFN-ß measured by gadolinium-enhancing lesions on T1-weighted images on MRI using a triple-dose gadolinium protocol and/or new or newly enlarging T2 lesions (T2 lesions: compared to a reference MRI performed within the last 18 months)
Exclusion Criteria:
* patients with previous or current disease of immune system
* active infections
* cardiovascular risk patients
* Patients unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01621269
Study Brief:
Protocol Section:
NCT01621269