ID
15280
Description
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. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.
Mots-clés
Versions (3)
- 17/09/2015 17/09/2015 - Julian Varghese
- 22/09/2015 22/09/2015 - Julian Varghese
- 24/05/2016 24/05/2016 -
Téléchargé le
24 mai 2016
DOI
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Licence
Creative Commons BY-NC 3.0 Legacy
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Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069
Eligibility
Description
Exclusion criteria
Description
hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0058218
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C3556178
Description
MS relapse
Type de données
boolean
Alias
- UMLS CUI [1]
- C0856120
Description
tuberculosis or active tuberculosis
Type de données
boolean
Alias
- UMLS CUI [1]
- C0041296
Description
severe impairment of liver function or persisting elevations except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).
Type de données
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
Description
serum creatinine
Type de données
boolean
Alias
- UMLS CUI [1]
- C0201976
Description
Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0518014
- UMLS CUI [2]
- C0019046
- UMLS CUI [3]
- C0023508
- UMLS CUI [4]
- C0027950
- UMLS CUI [5]
- C0005821
Description
Women of childbearing potential not utilizing highly effective contraception
Type de données
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
Description
Mental condition
Type de données
boolean
Alias
- UMLS CUI [1]
- C3840291
Description
Patient Non-Compliance
Type de données
boolean
Alias
- UMLS CUI [1]
- C0376405
Description
Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Systemic disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C0007222
- UMLS CUI [2]
- C0027765
- UMLS CUI [3]
- C0014130
- UMLS CUI [4]
- C0442893
Description
Crohn´s disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C0010346
Description
Immunologic Deficiency Syndromes | Malignant Neoplasms | Lymphoproliferative Disorders | Carcinoma, Basosquamous | Lymphatic Irradiation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021051
- UMLS CUI [2]
- C0006826
- UMLS CUI [3]
- C0024314
- UMLS CUI [4]
- C0007118
- UMLS CUI [5]
- C0024230
Description
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Type de données
boolean
Alias
- UMLS CUI [1]
- C0019699
- UMLS CUI [2]
- C0856706
- UMLS CUI [3]
- C1112419
Description
Acute or chronic infection
Type de données
boolean
Alias
- UMLS CUI [1]
- C0275518
- UMLS CUI [2]
- C0151317
Description
History of drug or alcohol abuse
Type de données
boolean
Alias
- UMLS CUI [1]
- C0237123
Description
Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001655
- UMLS CUI [2]
- C0001617
Description
Cytokine therapy | Immunoglobulins, Intravenous
Type de données
boolean
Alias
- UMLS CUI [1]
- C0199974
- UMLS CUI [2]
- C0085297
Description
Prior use of alemtuzumab or cladribine
Type de données
boolean
Alias
- UMLS CUI [1]
- C0383429
- UMLS CUI [2]
- C0092801
Description
Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).
Type de données
boolean
Alias
- UMLS CUI [1]
- C1699926
- UMLS CUI [2]
- C1172734
Description
Mitoxantrone | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | mycophenolate mofetil
Type de données
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
Description
teriflunomide | leflunomide
Type de données
boolean
Alias
- UMLS CUI [1]
- C1718383
- UMLS CUI [2]
- C0063041
Description
Investigational New Drugs
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013230
Description
Patient currently pregnant | Breast Feeding
Type de données
boolean
Alias
- UMLS CUI [1]
- C0549206
- UMLS CUI [2]
- C0006147
Description
Signature Screening Visit 1
Similar models
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])