ID

4876

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
Uploaded on

April 13, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00220779 Multiple sclerosis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

18 Years to 55 Years
Description

Age

Data type

boolean

Symptoms consistent with Multiple Sclerosis up to 5 years
Description

Symptoms of Multiple Sclerosis

Data type

boolean

Diagnosis of multiple sclerosis according to McDonald criteria.
Description

Diagnosis of Multiple Sclerosis

Data type

boolean

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)
Description

relapsing-remitting multiple sclerosis

Data type

boolean

Kurtzke Extended Disability Status Scale (EDSS) < 5.0
Description

Kurtzke Extended Disability Status Scale

Data type

boolean

Females or males, females of childbearing potential must use adequate contraception
Description

Contraception

Data type

boolean

Clinically stable for at least 30 days prior to entry
Description

Stable Disease

Data type

boolean

At least 9 hyperintense T2 lesions on MRI or 1 Gd-enhancing lesion according to McDonald/Barkhof dissemination-in-space criteria at entry
Description

Hyperintense lesions in the basal ganglia on MRI

Data type

boolean

Written informed consent obtained prior to the initiation of any study related procedures
Description

informed consent

Data type

boolean

Exclusion criteria
Description

Exclusion criteria

Females who are pregnant, breast feeding, or if, of childbearing potential, unwilling to practice adequate contraception throughout the study
Description

pregnant, breast feeding or without adequate contraception

Data type

boolean

Prior therapy with azathioprine or any immunosuppressant agents within 6 months prior to study entry
Description

Immunomodulatory or immunosuppressive therapy

Data type

boolean

Prior steroid, methylprednisolone or adrenocorticotropic hormone (ACTH) therapy within 30 days prior to study entry
Description

steroid therapy

Data type

boolean

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
Description

Therapy with interferons (Betaseron(R), Avonex(R), Rebif(R)), glatiramer acetate (Copaxone(R)) or IGIV

Data type

boolean

Use of an investigational compound within 6 months prior to study entry
Description

Use of an investigational compound

Data type

boolean

Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease (CCS III or IV), or malignant hypertension
Description

heart diseases

Data type

boolean

History of renal insufficiency or serum creatinine levels greater than 2.5 mg/dL (221 umol/L)
Description

renal insufficiency

Data type

boolean

Known selective IgA deficiency or known antibodies to IgA
Description

IgA deficiency

Data type

boolean

Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g., protein-losing enteropathies, nephrotic syndrome)
Description

regulation of protein catabolic process

Data type

boolean

Medical Concepts
Description

Medical Concepts

age
Description

age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
diagnosis
Description

diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Multiple Sclerosis
Description

Multiple Sclerosis

Data type

string

Alias
UMLS CUI
C0026769
SNOMED CT 2010_0731
24700007
MedDRA 13.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
Symptoms
Description

Symptoms

Data type

string

Alias
UMLS CUI
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
Multiple Sclerosis, Relapsing-Remitting
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

string

Alias
UMLS CUI
C0751967
SNOMED CT 2010_0731
426373005
MedDRA 13.1
10063399
Stable Disease
Description

Stable Disease

Data type

string

Alias
UMLS CUI
C0677946
Contraception
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Hyperintense lesions in the basal ganglia on MRI
Description

Hyperintense lesions in the basal ganglia on MRI

Data type

string

Alias
UMLS CUI
C1865351
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Mother currently breast-feeding
Description

Mother currently breast-feeding

Data type

string

Alias
UMLS CUI
C0585066
SNOMED CT 2010_0731
169750002
Immunomodulatory or immunosuppressive therapy
Description

Immunomodulatory or immunosuppressive therapy

Data type

string

Alias
UMLS CUI
C1963758
SNOMED CT 2010_0731
86553008
MedDRA 13.1
10067473
Therapeutic Corticosteroid
Description

corticosteroids

Data type

string

Alias
UMLS CUI
C0001617
SNOMED CT 2010_0731
79440004
steroids
Description

steroids

Data type

string

Alias
UMLS CUI
C0038317
SNOMED CT 2010_0731
116566001
Interferons
Description

Interferons

Data type

string

Alias
UMLS CUI
C0021747
SNOMED CT 2010_0731
49327004
LOINC Version 232
MTHU021353
Immunoglobulins, Intravenous
Description

Immunoglobulins, Intravenous

Data type

string

Alias
UMLS CUI
C0085297
SNOMED CT 2010_0731
350344000
HL7 V3 02-34
87
glatiramer acetate
Description

glatiramer acetate

Data type

string

Alias
UMLS CUI
C0289884
SNOMED CT 2010_0731
108755008
Cardiac disorder
Description

Heart Diseases

Data type

string

Alias
UMLS CUI
C0018799
SNOMED CT 2010_0731
56265001
MedDRA 13.1
10061024
ICD-10-CM Version 2010
I51.9
ICD-9-CM Version 2011
429.9
Renal Insufficiency
Description

renal insufficiency

Data type

string

Alias
UMLS CUI
C1565489
MedDRA 13.1
10022467
Immunoglobulin A deficiency
Description

Immunoglobulin A deficiency

Data type

string

Alias
UMLS CUI
C0162538
SNOMED CT 2010_0731
29260007
MedDRA 13.1
10021260
regulation of protein catabolic process
Description

regulation of protein catabolic process

Data type

string

Alias
UMLS CUI
C1158003
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
18 Years to 55 Years
boolean
Symptoms of Multiple Sclerosis
Item
Symptoms consistent with Multiple Sclerosis up to 5 years
boolean
Diagnosis of Multiple Sclerosis
Item
Diagnosis of multiple sclerosis according to McDonald criteria.
boolean
relapsing-remitting multiple sclerosis
Item
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)
boolean
Kurtzke Extended Disability Status Scale
Item
Kurtzke Extended Disability Status Scale (EDSS) < 5.0
boolean
Contraception
Item
Females or males, females of childbearing potential must use adequate contraception
boolean
Stable Disease
Item
Clinically stable for at least 30 days prior to entry
boolean
Hyperintense lesions in the basal ganglia on MRI
Item
At least 9 hyperintense T2 lesions on MRI or 1 Gd-enhancing lesion according to McDonald/Barkhof dissemination-in-space criteria at entry
boolean
informed consent
Item
Written informed consent obtained prior to the initiation of any study related procedures
boolean
Item Group
Exclusion criteria
pregnant, breast feeding or without adequate contraception
Item
Females who are pregnant, breast feeding, or if, of childbearing potential, unwilling to practice adequate contraception throughout the study
boolean
Immunomodulatory or immunosuppressive therapy
Item
Prior therapy with azathioprine or any immunosuppressant agents within 6 months prior to study entry
boolean
steroid therapy
Item
Prior steroid, methylprednisolone or adrenocorticotropic hormone (ACTH) therapy within 30 days prior to study entry
boolean
Therapy with interferons (Betaseron(R), Avonex(R), Rebif(R)), glatiramer acetate (Copaxone(R)) or IGIV
Item
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
boolean
Use of an investigational compound
Item
Use of an investigational compound within 6 months prior to study entry
boolean
heart diseases
Item
Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease (CCS III or IV), or malignant hypertension
boolean
renal insufficiency
Item
History of renal insufficiency or serum creatinine levels greater than 2.5 mg/dL (221 umol/L)
boolean
IgA deficiency
Item
Known selective IgA deficiency or known antibodies to IgA
boolean
regulation of protein catabolic process
Item
Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g., protein-losing enteropathies, nephrotic syndrome)
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)
MTHU008876 (LOINC Version 232)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Multiple Sclerosis
Item
Multiple Sclerosis
string
C0026769 (UMLS CUI)
24700007 (SNOMED CT 2010_0731)
10028245 (MedDRA 13.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
Symptoms
Item
Symptoms
string
C1457887 (UMLS CUI)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
Multiple Sclerosis, Relapsing-Remitting
Item
Multiple Sclerosis, Relapsing-Remitting
string
C0751967 (UMLS CUI)
426373005 (SNOMED CT 2010_0731)
10063399 (MedDRA 13.1)
Stable Disease
Item
Stable Disease
string
C0677946 (UMLS CUI)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Hyperintense lesions in the basal ganglia on MRI
Item
Hyperintense lesions in the basal ganglia on MRI
string
C1865351 (UMLS CUI)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Mother currently breast-feeding
Item
Mother currently breast-feeding
string
C0585066 (UMLS CUI)
169750002 (SNOMED CT 2010_0731)
Immunomodulatory or immunosuppressive therapy
Item
Immunomodulatory or immunosuppressive therapy
string
C1963758 (UMLS CUI)
86553008 (SNOMED CT 2010_0731)
10067473 (MedDRA 13.1)
corticosteroids
Item
Therapeutic Corticosteroid
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
steroids
Item
steroids
string
C0038317 (UMLS CUI)
116566001 (SNOMED CT 2010_0731)
Interferons
Item
Interferons
string
C0021747 (UMLS CUI)
49327004 (SNOMED CT 2010_0731)
MTHU021353 (LOINC Version 232)
Immunoglobulins, Intravenous
Item
Immunoglobulins, Intravenous
string
C0085297 (UMLS CUI)
350344000 (SNOMED CT 2010_0731)
87 (HL7 V3 02-34)
glatiramer acetate
Item
glatiramer acetate
string
C0289884 (UMLS CUI)
108755008 (SNOMED CT 2010_0731)
Heart Diseases
Item
Cardiac disorder
string
C0018799 (UMLS CUI)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
renal insufficiency
Item
Renal Insufficiency
string
C1565489 (UMLS CUI)
10022467 (MedDRA 13.1)
Immunoglobulin A deficiency
Item
Immunoglobulin A deficiency
string
C0162538 (UMLS CUI)
29260007 (SNOMED CT 2010_0731)
10021260 (MedDRA 13.1)
regulation of protein catabolic process
Item
regulation of protein catabolic process
string
C1158003 (UMLS CUI)
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