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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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