ID

4581

Description

Rebif(R) Versus Copaxone(R) in the Treatment of Relapsing Remitting Multiple Sclerosis Inclusion Criteria: - Be between 18 and 60 years of age - Have definite relapsing multiple sclerosis - Have had one or more relapses within the prior 12 months - Must be in a clinically stable or improving neurological state during the four weeks prior to Study Day 1 - EDSS score from 0 to 5.5, inclusive - 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 - Be willing and able to comply with the protocol for the duration of the study - Voluntarily provide written informed consent and, for USA sites only, a subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care. Exclusion Criteria: - Have secondary progressive MS or primary progressive MS - Prior use of any interferon or glatiramer acetate - 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. - Have a psychiatric disorder that is unstable or would preclude safe participation in the study - 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 - 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) - Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 1 - 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 - Prior use of cladribine or have received total lymphoid irradiation - 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 - 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 - 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) - Have had plasma exchange in 3 months prior to Study Day 1

Keywords

  1. 12/11/13 12/11/13 - Martin Dugas
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  3. 9/20/21 9/20/21 -
Uploaded on

December 11, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00078338 Multiple Sclerosis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Description

Inclusion criteria

Be between 18 and 60 years of age
Description

Age

Data type

boolean

Have definite relapsing multiple sclerosis. Have had one or more relapses within the prior 12 months
Description

Relapsing multiple sclerosis

Data type

boolean

Must be in a clinically stable or improving neurological state during the four weeks prior to Study Day 1
Description

Neurological state

Data type

boolean

EDSS score from 0 to 5.5, inclusive
Description

EDSS

Data type

boolean

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
Description

No pregnancy, no breast feeding

Data type

boolean

Exclusion criteria
Description

Exclusion criteria

Have secondary progressive MS or primary progressive MS
Description

Progressive MS

Data type

boolean

Prior use of any interferon or glatiramer acetate
Description

Prior use of any interferon or glatiramer acetate

Data type

boolean

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
Description

Steroid treatment

Data type

boolean

Have a psychiatric disorder that is unstable or would preclude safe participation in the study
Description

Psychiatric disorder

Data type

boolean

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
Description

Leukopenia

Data type

boolean

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)
Description

Liver disease

Data type

boolean

Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 1
Description

Prior cytokine or anti-cytokine therapy

Data type

boolean

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
Description

Prior use of immunomodulatory or immunosuppressive therapy

Data type

boolean

Prior use of cladribine or have received total lymphoid irradiation
Description

Prior use of cladribine or have received total lymphoid irradiation

Data type

boolean

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
Description

Allergy or hypersensitivity

Data type

boolean

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
Description

Investigational drugs

Data type

boolean

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)
Description

Systemic disease

Data type

boolean

Have had plasma exchange in 3 months prior to Study Day 1
Description

Plasma exchange

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
Relapsing-remitting multiple sclerosis
Description

Relapsing multiple sclerosis

Data type

string

Alias
UMLS CUI
C0751967
MedDRA Version 13.1
10063399
SNOMED CT 2010_0731
426373005
EDSS - Expanded disability status scale
Description

EDSS

Data type

string

Alias
UMLS CUI
C0451246
SNOMED CT 2010_0731
273554001
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding
Description

Breast feeding

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Serum HCG Measurement
Description

Serum HCG

Data type

string

Alias
UMLS CUI
C2348195
LOINC
2118-8
MedDRA 13.1
10036572
Progressive multiple sclerosis
Description

Progressive multiple sclerosis

Data type

string

Alias
UMLS CUI
C1095979
MedDRA Version 13.1
10053395
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Psychiatric disorders
Description

Psychiatric disorder

Data type

string

Alias
UMLS CUI
C0004936
MedDRA Version 13.1
10037175
SNOMED CT 2010_0731
74732009
CTCAE Version 4.03
E13867
White blood cell count
Description

WBC

Data type

string

Alias
SNOMED CT 2010_0731
767002
LOINC
6690-2
Aspartate Transaminase (AST) = Glutamate oxaloacetate transaminase (GOT)
Description

AST

Data type

string

Alias
SNOMED CT 2010_0731
26091008
UMLS CUI
C0004002
MedDRA Version 13.1
10003543
LOINC
1920-8
Alanine Transaminase (ALT) = glutamate pyruvate transaminase (GPT)
Description

ALT

Data type

string

Alias
SNOMED CT 2010_0731
56935002
UMLS CUI
C0001899
MedDRA Version 13.1
10001844
LOINC
1742-6
Radiotherapy
Description

Radiotherapy

Data type

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
Hypersensitivity to medication
Description

Allergic reaction, due to correct medicinal substance properly administered

Data type

string

Alias
UMLS CUI
C0274302
SNOMED CT 2010_0731
57302007
Therapeutic procedure
Description

Therapeutic procedure

Data type

string

Alias
UMLS CUI
C0087111

Similar models

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
C1095979 (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)

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