Description:

ODM derived from http://clinicaltrials.gov/ct2/show/NCT00220779?term=NCT00220779&rank=1

Link:
http://clinicaltrials.gov/ct2/show/NCT00220779?term=NCT00220779&rank=1
Keywords:
Versions (2)
  1. 2/16/12 2/16/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
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February 16, 2012

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License :
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00220779 Multiple sclerosis

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Details

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
18 Years to 55 Years
both
Symptoms consistent with Multiple Sclerosis up to 5 years
Diagnosis of multiple sclerosis according to McDonald criteria.
Diagnosis of relapsing-remitting (RR) multiple sclerosis (MS) (Defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery, periods between disease relapses characterized by lack of disease progression)
Kurtzke Extended Disability Status Scale (EDSS) < 5.0
Females or males, females of childbearing potential must use adequate contraception
Clinically stable for at least 30 days prior to entry
At least 9 hyperintense T2 lesions on MRI or 1 Gd-enhancing lesion according to McDonald/Barkhof dissemination-in-space criteria at entry
Written informed consent obtained prior to the initiation of any study related procedures
Exclusion criteria
Females who are pregnant, breast feeding, or if, of childbearing potential, unwilling to practice adequate contraception throughout the study
Prior therapy with azathioprine or any immunosuppressant agents within 6 months prior to study entry
Prior steroid, methylprednisolone or adrenocorticotropic hormone (ACTH) therapy within 30 days prior to study entry
Therapy with interferons (Betaseron(R), Avonex(R), Rebif(R)), glatiramer acetate (Copaxone(R)) or IGIV within 3 months prior to study entry or during the study
Use of an investigational compound within 6 months prior to study entry
Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease (CCS III or IV), or malignant hypertension
History of renal insufficiency or serum creatinine levels greater than 2.5 mg/dL (221 umol/L)
Known selective IgA deficiency or known antibodies to IgA
Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g., protein-losing enteropathies, nephrotic syndrome)
Medical Concepts
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