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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT01077466
Eligibility Criteria:
Inclusion Criteria:
* Age between 19 and 55 years
* Progressive disease course of multiple sclerosis (primary or secondary)
* Duration of progressive phase of at least 1 year
* Progression of \> 1 EDSS point during the last 2 years (\>½ EDSS point if EDSS \> 5,5)
* EDSS \</= 6.5
* Written and informed consent
Exclusion Criteria:
* Pregnancy, breast-feeding or lack of anti.conception for fertile women.
* Attack during the last month before inclusion.
* Treatment with methylprednisolone during 3 months before inclusion.
* Treatment with interferon-beta, glatirameracetate, immunoglobulin G or other immune-modulating treatment 3 months prior to inclusion.
* Treatment with mitoxantrone, cyclophosphamide, azathioprine or other strong immunosuppressive drug 6 months prior to inclusion.
* Prior experimental treatment with strong immunosuppressive drug which the treating physician means will influence the results of the trial.
* Diseases associated with immunodeficiency.
* Treatment with other anticoagulant than aspirin.
* Current malign disease.
* Diabetes Mellitus or other autoimmune disease.
* Renal insufficiency or creatinine \> 150 μmol/l.
* Travel in tropical areas 3 months prior to inclusion.
* Acute or chronic infectious diseases, which the treating physician finds relevant (e.g.hepatitis B virus, hepatitis C virus, HIV).
* Psychiatric disease or other circumstances that may limit the patients participation in the trial.
* Contraindication for MRI scan or gadolinium contrast .
* Known hypersensitivity to natalizumab.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT01077466
Study Brief:
Protocol Section:
NCT01077466