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:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-26 @ 3:21 PM
NCT ID:
NCT01080027
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a diagnosis of RRMS according to the Mc Donald criteria(2005)
* 18 to 60 years of age
* Expanded Disability Status Scale (EDSS) \< 6
* Naïve subjects or subjects treated with Rebif® New Formulation for no more than 6 weeks prior to enrollment
* Subjects who have given written informed consent to participate in the study
Exclusion Criteria:
* Primary progressive or secondary progressive MS
* Subjects previously administered IFN beta-1a (including Rebif®) or IFN beta-1b or glatiramer acetate or any other immunomodulatory or immunosuppressive agents or any other MS therapy in the past with the exception of Rebif® New Formulation for no more than 6 weeks prior to enrollment
* Subjects receiving oral or systemic corticosteroids or Adrenocorticotrophic hormone within 30 days of visit 1 (prior to enrolment)
* History of any chronic pain syndrome
* Known allergy to IFN or its excipients
* Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
* Inadequate liver function, defined by a alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN), or alkaline phosphatase \> 2 x ULN, or total bilirubin \> 2 x ULN if associated with any elevation of ALT or alkaline phosphatase
* Inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal
* Current or past (within the last 2 years) history of alcohol or drug abuse
* Contra-indications to IFN beta-1a
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01080027
Study Brief:
Protocol Section:
NCT01080027