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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT01310166
Eligibility Criteria:
Inclusion Criteria:
* Subjects with relapsing forms of MS defined by 2005 revised McDonald criteria
* Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
Exclusion Criteria:
* Patients with a manifestation of MS other than relapsing remitting MS
* Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome
* History or presence of malignancy in the last 5 years
* Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients
* Diagnosis of macular edema during Screening Phase
* Patients with active systemic bacterial, viral or fungal infections
* Negative for varicella-zoster virus IgG antibodies at Screening
* Patients who have been treated with cladribine, cyclophosphamide or mitoxantrone at any time
* History of cardiovascular disorder
* Women of child-baring potential and inadequate contraception
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01310166
Study Brief:
Protocol Section:
NCT01310166