Age
Item
between the ages of 18 and 50 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis Worsening Symptomatic | New or Worsening Symptom | Fever Absent | Communicable Disease Absent
Item
acute symptomatic exacerbation of ms present for great than 24 hours and less than or equal to 7 days at entry with new or worsening symptoms, and with signs referable to the symptoms; in the absence of a fever or active infection.
boolean
C0026769 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C3898139 (UMLS CUI [2])
C0015967 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Multiple Sclerosis, Acute Relapsing
Item
diagnosis of a relapsing form of multiple sclerosis before randomization as determined by poser or mcdonald criteria.
boolean
C0393664 (UMLS CUI [1])
EDSS
Item
expanded disability status scale (edss) score between 2 and 6.5, inclusive at entry.
boolean
C0451246 (UMLS CUI [1])
Optic Neuritis | Cerebellar Diseases | Brain Stem Dysfunction | Myelitis | brain dysfunction Focal | Dysfunction Sensory Focal
Item
episodes include study neurologist or neuro-ophthalmologist diagnosed: acute optic neuritis, cerebellar, brainstem dysfunction, myelitis, focal cerebral, and/or definitive focal sensory dysfunction.
boolean
C0029134 (UMLS CUI [1])
C0007760 (UMLS CUI [2])
C0006121 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C0026975 (UMLS CUI [4])
C0262405 (UMLS CUI [5,1])
C0205234 (UMLS CUI [5,2])
C3887504 (UMLS CUI [6,1])
C0445254 (UMLS CUI [6,2])
C0205234 (UMLS CUI [6,3])
Signs and Symptoms New | Worsening Sensory | Intestines Signs and Symptoms | Bladder Signs and Symptoms | Optic Neuritis
Item
new objective clinical finding other than a sensory exacerbation, or bowel/bladder signs alone. sensory deficits alone will not qualify except for optic neuritis.
boolean
C0037088 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0332271 (UMLS CUI [2,1])
C0445254 (UMLS CUI [2,2])
C0021853 (UMLS CUI [3,1])
C0037088 (UMLS CUI [3,2])
C0005682 (UMLS CUI [4,1])
C0037088 (UMLS CUI [4,2])
C0029134 (UMLS CUI [5])
Immunomodulation | Interferons | glatiramer acetate | Pregnancy Immunomodulation To be stopped
Item
subjects may continue on their current immunomodulating therapy (such as interferons or glatiramer acetate) throughout the course of the study. women who become pregnant after the 5-day treatment of steroids should discontinue immunomodulatory treatment.
boolean
C1963758 (UMLS CUI [1])
C0021747 (UMLS CUI [2])
C0289884 (UMLS CUI [3])
C0032961 (UMLS CUI [4,1])
C1963758 (UMLS CUI [4,2])
C1272691 (UMLS CUI [4,3])
Informed Consent | Screening test | Evaluation
Item
understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
boolean
C0021430 (UMLS CUI [1])
C0871311 (UMLS CUI [2])
C1261322 (UMLS CUI [3])
Systemic Corticosteroid Therapy
Item
any patients treated with systemic corticosteroid use within one month of the index episode at screening.
boolean
C4053960 (UMLS CUI [1])
Therapeutic immunosuppression | Mitoxantrone | Azathioprine | Immunoglobulins, Intravenous | Plasmapheresis
Item
prior use of immunosuppressive treatments within 90 days of index episode (mitoxantrone, azathioprine, ivig) or plasmapheresis.
boolean
C0021079 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0004482 (UMLS CUI [3])
C0085297 (UMLS CUI [4])
C0032134 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
any patient who is pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Multiple Sclerosis Test Functional | Timed 25-Foot Walk Functional Test Unable | Time to Complete 9-Hole Peg Test Unable | Paced auditory serial addition test Unable
Item
unable to perform the multiple sclerosis functional composite consisting of: timed 25-foot walk, 9-hole peg test, and paced auditory serial addition test (3 second).
boolean
C0026769 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
C3897356 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C3898195 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0589060 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
Peripheral Neuropathy | Cranial nerve diseases
Item
peripheral or cranial neuropathy as sole problem of acute episode.
boolean
C0031117 (UMLS CUI [1])
C0010266 (UMLS CUI [2])
Heart Disease Significant | Gastrointestinal Disease Significant | Liver disease Significant | Lung disease Significant | Kidney Disease Significant | Immune Deficiency Disease | Medical condition Excludes Steroid therapy
Item
history of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude corticosteroid therapy.
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0024115 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0750502 (UMLS CUI [5,2])
C1855771 (UMLS CUI [6])
C3843040 (UMLS CUI [7,1])
C0332196 (UMLS CUI [7,2])
C0149783 (UMLS CUI [7,3])
Multiple Sclerosis, Primary Progressive
Item
primary progressive multiple sclerosis (ppms).
boolean
C0751964 (UMLS CUI [1])
Study Subject Participation Status
Item
previous participation in this study.
boolean
C2348568 (UMLS CUI [1])