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:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT00986960
Eligibility Criteria:
Inclusion Criteria:
* Patient diagnosed with MS according to McDonald criteria
* Age 18-65
* Have a RR disease course
* Have EDSS scores 0-5.5
* Have a disease duration \<20 years
* Sub-optimal response to Interferon beta-1a I.M. (Avonex®) while being on therapy for at least 6 months defined as:
* presence of a documented relapse within the last 12 months
* or the presence of at least one enhancing T1 Gd lesion on an MRI performed within previous 3 months
* Signed informed consent
* Normal kidney functioning (creatinine clearance \>59)
* None of the exclusion criteria
Exclusion Criteria:
* Presence of relapse or steroid treatment within 60 days prior to study enrollment
* Presence of neutralizing antibodies to IFNβ-1a I.M. prior to study enrollment
* Presence of optic neuritis within less than 6 months prior to study enrollment
* Diagnosis of osteoporosis (T score ≥2.5 SD)
* Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
* Abnormal blood tests, performed during the screening visit including: hepatitis B or hepatitis C, ALT or AST greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes
* History of depression while on IFNβ-1a I.M.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00986960
Study Brief:
Protocol Section:
NCT00986960