ID

4581

Beschreibung

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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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

Stichworte

  1. 11.12.13 11.12.13 - Martin Dugas
  2. 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
  3. 20.09.21 20.09.21 -
Hochgeladen am

11. Dezember 2013

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00078338 Multiple Sclerosis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschreibung

Einschlusskriterien

Age
Beschreibung

Age

Datentyp

boolean

Relapsing multiple sclerosis
Beschreibung

Relapsing multiple sclerosis

Datentyp

boolean

Neurological state
Beschreibung

Neurological state

Datentyp

boolean

EDSS
Beschreibung

EDSS

Datentyp

boolean

No pregnancy, no breast feeding
Beschreibung

No pregnancy, no breast feeding

Datentyp

boolean

Ausschlusskriterien
Beschreibung

Ausschlusskriterien

Progressive MS
Beschreibung

Progressive MS

Datentyp

boolean

Prior use of any interferon or glatiramer acetate
Beschreibung

Prior use of any interferon or glatiramer acetate

Datentyp

boolean

Steroid treatment
Beschreibung

Steroid treatment

Datentyp

boolean

Psychiatric disorder
Beschreibung

Psychiatric disorder

Datentyp

boolean

Leukopenia
Beschreibung

Leukopenia

Datentyp

boolean

Liver disease
Beschreibung

Liver disease

Datentyp

boolean

Prior cytokine or anti-cytokine therapy
Beschreibung

Prior cytokine or anti-cytokine therapy

Datentyp

boolean

Prior use of immunomodulatory or immunosuppressive therapy
Beschreibung

Prior use of immunomodulatory or immunosuppressive therapy

Datentyp

boolean

Prior use of cladribine or have received total lymphoid irradiation
Beschreibung

Prior use of cladribine or have received total lymphoid irradiation

Datentyp

boolean

Allergy or hypersensitivity
Beschreibung

Allergy or hypersensitivity

Datentyp

boolean

Investigational drugs
Beschreibung

Investigational drugs

Datentyp

boolean

Systemic disease
Beschreibung

Systemic disease

Datentyp

boolean

Plasma exchange
Beschreibung

Plasma exchange

Datentyp

boolean

Medizinische Konzepte
Beschreibung

Medizinische Konzepte

Age
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Beschreibung

Diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Relapsing multiple sclerosis
Beschreibung

Relapsing multiple sclerosis

Datentyp

string

Alias
UMLS CUI
C0751967
MedDRA Version 13.1
10063399
SNOMED CT 2010_0731
426373005
EDSS
Beschreibung

EDSS

Datentyp

string

Alias
UMLS CUI
C0451246
SNOMED CT 2010_0731
273554001
pregnant
Beschreibung

pregnant

Datentyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding
Beschreibung

Breast feeding

Datentyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Serum HCG
Beschreibung

Serum HCG

Datentyp

string

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

Progressive multiple sclerosis

Datentyp

string

Alias
UMLS CUI
C1095979
MedDRA Version 13.1
10053395
Pharmaceutical Preparations
Beschreibung

Pharmaceutical Preparations

Datentyp

string

Alias
UMLS CUI
C0013227
Psychiatric disorder
Beschreibung

Psychiatric disorder

Datentyp

string

Alias
UMLS CUI
C0004936
MedDRA Version 13.1
10037175
SNOMED CT 2010_0731
74732009
CTCAE Version 4.03
E13867
WBC
Beschreibung

WBC

Datentyp

string

Alias
SNOMED CT 2010_0731
767002
LOINC
6690-2
AST
Beschreibung

AST

Datentyp

string

Alias
SNOMED CT 2010_0731
26091008
UMLS CUI
C0004002
MedDRA Version 13.1
10003543
LOINC
1920-8
ALT
Beschreibung

ALT

Datentyp

string

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

Radiotherapy

Datentyp

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
Allergic reaction, due to correct medicinal substance properly administered
Beschreibung

Allergic reaction, due to correct medicinal substance properly administered

Datentyp

string

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

Therapeutic procedure

Datentyp

string

Alias
UMLS CUI
C0087111

Ähnliche Modelle

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Einschlusskriterien
Age
Item
boolean
Relapsing multiple sclerosis
Item
boolean
Neurological state
Item
boolean
EDSS
Item
boolean
No pregnancy, no breast feeding
Item
boolean
Item Group
Ausschlusskriterien
Progressive MS
Item
boolean
Prior use of any interferon or glatiramer acetate
Item
boolean
Steroid treatment
Item
boolean
Psychiatric disorder
Item
boolean
Leukopenia
Item
boolean
Liver disease
Item
boolean
Prior cytokine or anti-cytokine therapy
Item
boolean
Prior use of immunomodulatory or immunosuppressive therapy
Item
boolean
Prior use of cladribine or have received total lymphoid irradiation
Item
boolean
Allergy or hypersensitivity
Item
boolean
Investigational drugs
Item
boolean
Systemic disease
Item
boolean
Plasma exchange
Item
boolean
Item Group
Medizinische Konzepte
Age
Item
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
Relapsing multiple sclerosis
Item
string
C0751967 (UMLS CUI)
10063399 (MedDRA Version 13.1)
426373005 (SNOMED CT 2010_0731)
EDSS
Item
string
C0451246 (UMLS CUI)
273554001 (SNOMED CT 2010_0731)
pregnant
Item
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Breast feeding
Item
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Serum HCG
Item
string
C2348195 (UMLS CUI)
2118-8 (LOINC)
10036572 (MedDRA 13.1)
Progressive multiple sclerosis
Item
string
C1095979 (UMLS CUI)
10053395 (MedDRA Version 13.1)
Pharmaceutical Preparations
Item
string
C0013227 (UMLS CUI)
Psychiatric disorder
Item
string
C0004936 (UMLS CUI)
10037175 (MedDRA Version 13.1)
74732009 (SNOMED CT 2010_0731)
E13867 (CTCAE Version 4.03)
WBC
Item
string
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC)
AST
Item
string
26091008 (SNOMED CT 2010_0731)
C0004002 (UMLS CUI)
10003543 (MedDRA Version 13.1)
1920-8 (LOINC)
ALT
Item
string
56935002 (SNOMED CT 2010_0731)
C0001899 (UMLS CUI)
10001844 (MedDRA Version 13.1)
1742-6 (LOINC)
Radiotherapy
Item
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
Allergic reaction, due to correct medicinal substance properly administered
Item
string
C0274302 (UMLS CUI)
57302007 (SNOMED CT 2010_0731)
Therapeutic procedure
Item
string
C0087111 (UMLS CUI)

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