ID
12084
Beschreibung
Study documentation part: Visits 1 (Screening), Study week -4 to 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.
Stichworte
Versionen (3)
- 17.09.15 17.09.15 - Julian Varghese
- 22.09.15 22.09.15 - Julian Varghese
- 24.05.16 24.05.16 -
Hochgeladen am
17. September 2015
DOI
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Lizenz
Creative Commons BY-NC 3.0 Legacy
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Relapsing Remitting Multiple Sclerosis NCT02461069 - Visit 1 (Screening)
Eligibility
Beschreibung
Exclusion criteria
Beschreibung
hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0058218
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C3556178
Beschreibung
MS relapse
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0856120
Beschreibung
tuberculosis or active tuberculosis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0041296
Beschreibung
severe impairment of liver function or persisting elevations except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232741
- UMLS CUI [2]
- C0201836
- UMLS CUI [3]
- C0201836
- UMLS CUI [4]
- C0201899
- UMLS CUI [5]
- C0201916
- UMLS CUI [6]
- C0017551
Beschreibung
serum creatinine
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0518014
- UMLS CUI [2]
- C0019046
- UMLS CUI [3]
- C0023508
- UMLS CUI [4]
- C0027950
- UMLS CUI [5]
- C0005821
Beschreibung
Women of childbearing potential not utilizing highly effective contraception
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
Beschreibung
Mental condition
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3840291
Beschreibung
Patient Non-Compliance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0376405
Beschreibung
Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Systemic disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0007222
- UMLS CUI [2]
- C0027765
- UMLS CUI [3]
- C0014130
- UMLS CUI [4]
- C0442893
Beschreibung
Crohn´s disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0010346
Beschreibung
Immunologic Deficiency Syndromes | Malignant Neoplasms | Lymphoproliferative Disorders | Carcinoma, Basosquamous | Lymphatic Irradiation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021051
- UMLS CUI [2]
- C0006826
- UMLS CUI [3]
- C0024314
- UMLS CUI [4]
- C0007118
- UMLS CUI [5]
- C0024230
Beschreibung
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019699
- UMLS CUI [2]
- C0856706
- UMLS CUI [3]
- C1112419
Beschreibung
Acute or chronic infection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0275518
- UMLS CUI [2]
- C0151317
Beschreibung
History of drug or alcohol abuse
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0237123
Beschreibung
Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001655
- UMLS CUI [2]
- C0001617
Beschreibung
Cytokine therapy | Immunoglobulins, Intravenous
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0199974
- UMLS CUI [2]
- C0085297
Beschreibung
Prior use of alemtuzumab or cladribine
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0383429
- UMLS CUI [2]
- C0092801
Beschreibung
Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1699926
- UMLS CUI [2]
- C1172734
Beschreibung
Mitoxantrone | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | mycophenolate mofetil
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0026259
- UMLS CUI [2]
- C0004482
- UMLS CUI [3]
- C0010583
- UMLS CUI [4]
- C0010592
- UMLS CUI [5]
- C0025677
- UMLS CUI [6]
- C0209368
Beschreibung
teriflunomide | leflunomide
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1718383
- UMLS CUI [2]
- C0063041
Beschreibung
Investigational New Drugs
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013230
Beschreibung
Patient currently pregnant | Breast Feeding
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0549206
- UMLS CUI [2]
- C0006147
Beschreibung
Signature Screening Visit 1
Ähnliche Modelle
Eligibility
C0749659 (UMLS CUI [1,2])
C0058218 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3556178 (UMLS CUI [2,2])
C0201836 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201916 (UMLS CUI [5])
C0017551 (UMLS CUI [6])
C0019046 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0027950 (UMLS CUI [4])
C0005821 (UMLS CUI [5])
C0700589 (UMLS CUI [2])
C0027765 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0442893 (UMLS CUI [4])
C0006826 (UMLS CUI [2])
C0024314 (UMLS CUI [3])
C0007118 (UMLS CUI [4])
C0024230 (UMLS CUI [5])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
C0151317 (UMLS CUI [2])
C0001617 (UMLS CUI [2])
C0085297 (UMLS CUI [2])
C0092801 (UMLS CUI [2])
C1172734 (UMLS CUI [2])
C0004482 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0025677 (UMLS CUI [5])
C0209368 (UMLS CUI [6])
C0063041 (UMLS CUI [2])
C0006147 (UMLS CUI [2])