ID
42206
Descrizione
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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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
versioni (3)
- 11/12/13 11/12/13 - Martin Dugas
- 13/04/21 13/04/21 - Dr. rer. medic Philipp Neuhaus
- 20/09/21 20/09/21 -
Caricato su
13 aprile 2021
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00078338 Multiple Sclerosis
Eligibility
- StudyEvent: Eligibility
Descrizione
Ausschlusskriterien
Descrizione
Progressive MS
Tipo di dati
boolean
Descrizione
Prior use of any interferon or glatiramer acetate
Tipo di dati
boolean
Descrizione
Steroid treatment
Tipo di dati
boolean
Descrizione
Psychiatric disorder
Tipo di dati
boolean
Descrizione
Leukopenia
Tipo di dati
boolean
Descrizione
Liver disease
Tipo di dati
boolean
Descrizione
Prior cytokine or anti-cytokine therapy
Tipo di dati
boolean
Descrizione
Prior use of immunomodulatory or immunosuppressive therapy
Tipo di dati
boolean
Descrizione
Prior use of cladribine or have received total lymphoid irradiation
Tipo di dati
boolean
Descrizione
Allergy or hypersensitivity
Tipo di dati
boolean
Descrizione
Investigational drugs
Tipo di dati
boolean
Descrizione
Systemic disease
Tipo di dati
boolean
Descrizione
Plasma exchange
Tipo di dati
boolean
Descrizione
Medizinische Konzepte
Descrizione
Age
Tipo di dati
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Descrizione
Diagnosis
Tipo di dati
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Descrizione
Relapsing multiple sclerosis
Tipo di dati
string
Alias
- UMLS CUI
- C0751967
- MedDRA Version 13.1
- 10063399
- SNOMED CT 2010_0731
- 426373005
Descrizione
EDSS
Tipo di dati
string
Alias
- UMLS CUI
- C0451246
- SNOMED CT 2010_0731
- 273554001
Descrizione
pregnant
Tipo di dati
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Descrizione
Breast feeding
Tipo di dati
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Descrizione
Serum HCG
Tipo di dati
string
Alias
- UMLS CUI
- C2348195
- LOINC
- 2118-8
- MedDRA 13.1
- 10036572
Descrizione
Progressive multiple sclerosis
Tipo di dati
string
Alias
- UMLS CUI
- C1095979
- MedDRA Version 13.1
- 10053395
Descrizione
Pharmaceutical Preparations
Tipo di dati
string
Alias
- UMLS CUI
- C0013227
Descrizione
Psychiatric disorder
Tipo di dati
string
Alias
- UMLS CUI
- C0004936
- MedDRA Version 13.1
- 10037175
- SNOMED CT 2010_0731
- 74732009
- CTCAE Version 4.03
- E13867
Descrizione
WBC
Tipo di dati
string
Alias
- SNOMED CT 2010_0731
- 767002
- LOINC
- 6690-2
Descrizione
AST
Tipo di dati
string
Alias
- SNOMED CT 2010_0731
- 26091008
- UMLS CUI
- C0004002
- MedDRA Version 13.1
- 10003543
- LOINC
- 1920-8
Descrizione
ALT
Tipo di dati
string
Alias
- SNOMED CT 2010_0731
- 56935002
- UMLS CUI
- C0001899
- MedDRA Version 13.1
- 10001844
- LOINC
- 1742-6
Descrizione
Radiotherapy
Tipo di dati
string
Alias
- UMLS CUI
- C1522449
- SNOMED CT 2010_0731
- 302505005
Descrizione
Allergic reaction, due to correct medicinal substance properly administered
Tipo di dati
string
Alias
- UMLS CUI
- C0274302
- SNOMED CT 2010_0731
- 57302007
Descrizione
Therapeutic procedure
Tipo di dati
string
Alias
- UMLS CUI
- C0087111
Similar models
Eligibility
- StudyEvent: Eligibility
102518004 (SNOMED CT 2010_0731)
439401001 (SNOMED CT 2010_0731)
10063399 (MedDRA Version 13.1)
426373005 (SNOMED CT 2010_0731)
273554001 (SNOMED CT 2010_0731)
10036586 (MedDRA 13.1)
10006247 (MedDRA 13.1)
10053395 (MedDRA Version 13.1)
10037175 (MedDRA Version 13.1)
74732009 (SNOMED CT 2010_0731)
E13867 (CTCAE Version 4.03)
302505005 (SNOMED CT 2010_0731)
57302007 (SNOMED CT 2010_0731)