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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT00616733
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of clinically isolated syndrome or a relapsing form(s) of MS, based on Poser or McDonald criteria (may include patients with secondary progressive disease)
* Clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain MRI scan within the past 12 months
* Baseline EDSS score of 0 - 6.5
* Female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception
Exclusion Criteria:
* Primary progressive MS
* Any medical condition that predisposes to immunocompromise
* History of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection
* Concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)
* Treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation
* Treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation
* Treatment with interferon beta or glatiramer acetate within 2 months of study initiation
* Prior treatment with natalizumab or rituximab
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00616733
Study Brief:
Protocol Section:
NCT00616733