Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
Age
Item
Be between 18 and 60 years of age
boolean
Relapsing multiple sclerosis
Item
Have definite relapsing multiple sclerosis. Have had one or more relapses within the prior 12 months
boolean
Neurological state
Item
Must be in a clinically stable or improving neurological state during the four weeks prior to Study Day 1
boolean
EDSS
Item
EDSS score from 0 to 5.5, inclusive
boolean
No pregnancy, no breast feeding
Item
If female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and be neither pregnant nor breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum hCG pregnancy test within 7 days of Study Day 1 and a negative urine pregnancy test on Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterilized
boolean
Item Group
Exclusion criteria
Progressive MS
Item
Have secondary progressive MS or primary progressive MS
boolean
Prior use of any interferon or glatiramer acetate
Item
Prior use of any interferon or glatiramer acetate
boolean
Steroid treatment
Item
Have had treatment with oral or systemic corticosteroids or ACTH within 4 weeks of Study Day 1 and within 7 days prior to the Day 1 MRI
boolean
Psychiatric disorder
Item
Have a psychiatric disorder that is unstable or would preclude safe participation in the study
boolean
Leukopenia
Item
Have significant leukopenia (white blood cell count < 0.5 times the lower limit of normal of the central laboratory) within 7 days of Study Day 1
boolean
Liver disease
Item
Have elevated liver function tests (AST, ALT, alkaline phosphatase > 2.0 times the upper limit of normal (ULN) of the central laboratory, or total bilirubin > 1.5 times the ULN of the central laboratory) within 7 days of Study Day 1 or a history of hepatitis (including infectious or drug-induced)
boolean
Prior cytokine or anti-cytokine therapy
Item
Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 1
boolean
Prior use of immunomodulatory or immunosuppressive therapy
Item
Prior use of immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone) within the 12 months prior to Study Day 1
boolean
Prior use of cladribine or have received total lymphoid irradiation
Item
Prior use of cladribine or have received total lymphoid irradiation
boolean
Allergy or hypersensitivity
Item
Have allergy or hypersensitivity to human serum albumin, mannitol, glatiramer acetate, natural or recombinant interferon-β, or any other components of the study drugs or gadolinium DTPA
boolean
Investigational drugs
Item
Have taken intravenous immunoglobulin or any other investigational drug or taken part in any experimental procedure in the 6 months prior to Study Day 1
boolean
Systemic disease
Item
Presence of systemic disease that might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, HIV, HTLV-1)
boolean
Plasma exchange
Item
Have had plasma exchange in 3 months prior to Study Day 1
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
Relapsing multiple sclerosis
Item
Relapsing-remitting multiple sclerosis
string
C0751967 (UMLS CUI)
10063399 (MedDRA Version 13.1)
426373005 (SNOMED CT 2010_0731)
EDSS
Item
EDSS - Expanded disability status scale
string
C0451246 (UMLS CUI)
273554001 (SNOMED CT 2010_0731)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Breast feeding
Item
Breast feeding
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Serum HCG
Item
Serum HCG Measurement
string
C2348195 (UMLS CUI)
2118-8 (LOINC)
10036572 (MedDRA 13.1)
Progressive multiple sclerosis
Item
Progressive multiple sclerosis
string
C0393665 (UMLS CUI)
10053395 (MedDRA Version 13.1)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Psychiatric disorder
Item
Psychiatric disorders
string
C0004936 (UMLS CUI)
10037175 (MedDRA Version 13.1)
74732009 (SNOMED CT 2010_0731)
E13867 (CTCAE Version 4.03)
WBC
Item
White blood cell count
string
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC)
AST
Item
Aspartate Transaminase (AST) = Glutamate oxaloacetate transaminase (GOT)
string
26091008 (SNOMED CT 2010_0731)
C0004002 (UMLS CUI)
10003543 (MedDRA Version 13.1)
1920-8 (LOINC)
ALT
Item
Alanine Transaminase (ALT) = glutamate pyruvate transaminase (GPT)
string
56935002 (SNOMED CT 2010_0731)
C0001899 (UMLS CUI)
10001844 (MedDRA Version 13.1)
1742-6 (LOINC)
Radiotherapy
Item
Radiotherapy
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
Allergic reaction, due to correct medicinal substance properly administered
Item
Hypersensitivity to medication
string
C0274302 (UMLS CUI)
57302007 (SNOMED CT 2010_0731)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial