Multiple Sclerosis
Item
Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001)
boolean
C0026769 (UMLS CUI [1])
Age
Item
between the ages of 18 and 50, inclusive
boolean
C0001779 (UMLS CUI [1])
Baseline EDSS Score
Item
baseline edss score between 0.0 and 5.0, inclusive.
boolean
C3830336 (UMLS CUI [1])
MS relapse
Item
At least one MS-relapse within 12 month prior to randomization. Time since relapse should be measured from the time of relapse onset.
boolean
C0856120 (UMLS CUI [1])
Cranial mri scan
Item
cranial mri scan demonstrating lesion(s) consistent with MS.
boolean
C0412674 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
written informed consent
Item
Subject has given written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
progressive relapsing MS
Item
Subject has a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS defined by Lublin and Reingold (Lublin and Reingold, 1996). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 month.
boolean
C0751964 (UMLS CUI [1,1])
C0751965 (UMLS CUI [1,2])
C0393666 (UMLS CUI [1,3])
MS relapse
Item
MS relapse has occurred,in the opinion of the investigator, within 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse.
boolean
C0856120 (UMLS CUI [1])
Communicable Disease
Item
Subject has had a clinically significant infectious illness within 30 days prior to randomization.
boolean
C0009450 (UMLS CUI [1])
abnormal laboratory results contraindicative for the administration of a recombinant humanized antibody
Item
history of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent for 116 weeks.
boolean
C1254595 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C2985546 (UMLS CUI [1,3])
drug hypersensitivity
Item
history of severe allergic or anaphylactic reactions or known drug hypersensitivity.
boolean
C0013182 (UMLS CUI [1])
unable to perform the timed 25-foot walk, 9hpt, and pasat 3.
Item
Unable to perform the timed 25-foot walk, 9hpt, and pasat 3.
boolean
C3897356 (UMLS CUI [1])
C0451335 (UMLS CUI [2])
C0589060 (UMLS CUI [3])
abnormal blood tests
Item
abnormal blood tests performed at the screening visit.
boolean
C0854146 (UMLS CUI [1])
Interferon beta or glatiramer acetate
Item
Subject has history of treatment with either interferon-ß or glatiramer acetate for a total of 6 or more month.
boolean
C0015980 (UMLS CUI [1,1])
C0289884 (UMLS CUI [1,2])
Prior treatment
Item
Subject has had prior treatment with any of the following medications: total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination, natalizumab or any other therapeutic monoclonal antibody.
boolean
C1514463 (UMLS CUI [1,1])
C0024230 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0092801 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0042196 (UMLS CUI [3,2])
C0039194 (UMLS CUI [3,3])
C1514463 (UMLS CUI [4,1])
C1172734 (UMLS CUI [4,2])
C1514463 (UMLS CUI [5,1])
C0003250 (UMLS CUI [5,2])
Prior treatment with Mitoxantrone or Cyclophosphamide
Item
Subject has had any treatment with any of the following medications within 1 year prior to randomization: Mitoxantrone or Cyclophosphamide
boolean
C1514463 (UMLS CUI [1,1])
C0026259 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0010583 (UMLS CUI [2,2])
Prior treatment
Item
Subject has had treatment with any of the following medications or procedures within 6 month prior to randomization: cyclosporine, azathioprine, methotrexate, glatiramer acetate, interferonß-1b or INFß-1a, intravenous immunoglobulin (IVIG), plasmapheresis or cytapheresis.
boolean
C1514463 (UMLS CUI [1,1])
C0010592 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0004482 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0025677 (UMLS CUI [3,2])
C1514463 (UMLS CUI [4,1])
C0289884 (UMLS CUI [4,2])
C1514463 (UMLS CUI [5,1])
C0244713 (UMLS CUI [5,2])
C1514463 (UMLS CUI [6,1])
C0763140 (UMLS CUI [6,2])
C1514463 (UMLS CUI [7,1])
C0085297 (UMLS CUI [7,2])
C1514463 (UMLS CUI [8,1])
C0032134 (UMLS CUI [8,2])
C1514463 (UMLS CUI [9,1])
C0079186 (UMLS CUI [9,2])
Prior treatment with steroids
Item
Subject has had treatment with any of the following medications within 50 days prior to randomization: intravenous corticosteroid treatment or oral corticosteroid treatment
boolean
C1514463 (UMLS CUI [1,1])
C0563322 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0574135 (UMLS CUI [2,2])
Substance Use Disorders
Item
Subject has had a history of alcohol or drug abuse within 2 years prior to randomization.
boolean
C0038586 (UMLS CUI [1])
Female of childbearing potential
Item
Subject is a female who is not postmenopausal for at least one year, surgically sterile, or willing to practice effective contraception during the study. The rhythm method is not to be used as the sole method of contraception.
boolean
C1960468 (UMLS CUI [1])
Pregnancy
Item
A nursing mother, pregnant woman, or woman planning to become pregnant while on study.
boolean
C0032961 (UMLS CUI [1])
Previous participation in this study
Item
Subject has had previous participation in this study.
boolean
C2348568 (UMLS CUI [1])
Previous participation in natalizumab studies
Item
Subject has had participation in previous natalizumab studies (unless subject was on placebo.).*
boolean
C2348568 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
Item
* If a subject was on placebo in a previous natalizumab study, please enter that study number and the subject ID from that study here.
text
C1172734 (UMLS CUI [1,1])
C0032042 (UMLS CUI [1,2])
Code List
* If a subject was on placebo in a previous natalizumab study, please enter that study number and the subject ID from that study here.
CL Item
Study No: (Study No:)
CL Item
Subject ID: (Subject ID:)
Compliance
Item
Subject is unwilling or is unable to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject´s ability to comply with the study protocol.
boolean
C1321605 (UMLS CUI [1])
Exclusion criteria
Item
Subject is determined unsuitable for enrollment into this study for any other reason in the opinion of the Investigator and/or the Sponsor.
boolean
C0680251 (UMLS CUI [1])