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to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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