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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT02254304
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects between 18 to 65 years of age
* Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined in the protocol
* Subjects diagnosed with CIS or RMS according to the revised McDonald criteria (2010)
* Treatment-naive subjects or subjects treated with Rebif® multi-dose injected by RebiSmart™ for no longer than 6 weeks prior to Baseline visit
* Subjects that are able to self-inject with RebiSmart™ (in the opinion of the physician)
* Subjects with Expanded Disability Status Scale (EDSS) score less than (\<) 6 (inclusive) at Baseline
* Signed informed consent and subject data collection form
Exclusion Criteria:
* Subjects experiencing a relapse within 30 days before Baseline
* Participation in other studies within 30 days before Baseline
* Received any MS therapy within 6 months prior to study enrolment (for example, other disease-modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif® multi-dose injected by RebiSmart™
* Any visual or physical impairment that precludes the subject from self-injecting the treatment using the RebiSmart™
* Pregnancy and breast-feeding
* Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure, as per investigator opinion
* Current or past (within the last 2 years) history of alcohol or drug abuse
* Have any contra-indications to treatment with interferon beta-1a according to Summary of Product Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02254304
Study Brief:
Protocol Section:
NCT02254304