ID

30936

Descrição

12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00616733

Link

https://clinicaltrials.gov/show/NCT00616733

Palavras-chave

Versões (2)
  1. 04/07/2018 04/07/2018 -
  2. 04/07/2018 04/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de julho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00616733

Inglês

Eligibility Multiple Sclerosis NCT00616733

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of clinically isolated syndrome or a relapsing form(s) of ms, based on poser or mcdonald criteria (may include patients with secondary progressive disease)
Descrição

Clinically isolated syndrome | Multiple Sclerosis, Acute Relapsing | Multiple Sclerosis, Secondary Progressive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2921627
UMLS CUI [2]
C0393664
UMLS CUI [3]
C0751965
clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain mri scan within the past 12 months
Descrição

Relapse Clinical | Gadolinium-Enhancing Lesion MRI scan brain

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C1333400
UMLS CUI [2,2]
C0412675
baseline edss score of 0 - 6.5
Descrição

EDSS

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451246
female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception
Descrição

Gender Sexually active Barrier Contraception Double | Exception Female Sterilization | Exception Postmenopausal state

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0004764
UMLS CUI [1,4]
C0205173
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015787
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0232970
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary progressive ms
Descrição

Multiple Sclerosis, Primary Progressive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751964
any medical condition that predisposes to immunocompromise
Descrição

Medical condition predisposing Immunocompromised patient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0231203
UMLS CUI [1,3]
C0085393
history of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection
Descrição

Malignant Neoplasms | Tuberculosis | Invasive Fungal Infections | Herpes zoster disease | Opportunistic Infections | Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0041296
UMLS CUI [3]
C1262313
UMLS CUI [4]
C0019360
UMLS CUI [5]
C0029118
UMLS CUI [6]
C0009450
concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)
Descrição

Autoimmune Disease | Rheumatoid Arthritis | Lupus Erythematosus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0409974
treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation
Descrição

Cyclophosphamide | Mitoxantrone

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0010583
UMLS CUI [2]
C0026259
treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation
Descrição

Cyclosporine | Azathioprine | Methotrexate | Immunosuppressive Agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2]
C0004482
UMLS CUI [3]
C0025677
UMLS CUI [4]
C0021081
treatment with interferon beta or glatiramer acetate within 2 months of study initiation
Descrição

Interferon-beta | Glatiramer acetate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0015980
UMLS CUI [2]
C0289884
prior treatment with natalizumab or rituximab
Descrição

natalizumab | rituximab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1172734
UMLS CUI [2]
C0393022
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Similar models

Eligibility Multiple Sclerosis NCT00616733

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Clinically isolated syndrome | Multiple Sclerosis, Acute Relapsing | Multiple Sclerosis, Secondary Progressive
Item
diagnosis of clinically isolated syndrome or a relapsing form(s) of ms, based on poser or mcdonald criteria (may include patients with secondary progressive disease)
boolean
C2921627 (UMLS CUI [1])
C0393664 (UMLS CUI [2])
C0751965 (UMLS CUI [3])
Relapse Clinical | Gadolinium-Enhancing Lesion MRI scan brain
Item
clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain mri scan within the past 12 months
boolean
C0035020 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1333400 (UMLS CUI [2,1])
C0412675 (UMLS CUI [2,2])
EDSS
Item
baseline edss score of 0 - 6.5
boolean
C0451246 (UMLS CUI [1])
Gender Sexually active Barrier Contraception Double | Exception Female Sterilization | Exception Postmenopausal state
Item
female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0004764 (UMLS CUI [1,3])
C0205173 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0015787 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0232970 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Multiple Sclerosis, Primary Progressive
Item
primary progressive ms
boolean
C0751964 (UMLS CUI [1])
Medical condition predisposing Immunocompromised patient
Item
any medical condition that predisposes to immunocompromise
boolean
C3843040 (UMLS CUI [1,1])
C0231203 (UMLS CUI [1,2])
C0085393 (UMLS CUI [1,3])
Malignant Neoplasms | Tuberculosis | Invasive Fungal Infections | Herpes zoster disease | Opportunistic Infections | Communicable Disease
Item
history of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection
boolean
C0006826 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
C1262313 (UMLS CUI [3])
C0019360 (UMLS CUI [4])
C0029118 (UMLS CUI [5])
C0009450 (UMLS CUI [6])
Autoimmune Disease | Rheumatoid Arthritis | Lupus Erythematosus
Item
concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)
boolean
C0004364 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
Cyclophosphamide | Mitoxantrone
Item
treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation
boolean
C0010583 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
Cyclosporine | Azathioprine | Methotrexate | Immunosuppressive Agents
Item
treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation
boolean
C0010592 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
Interferon-beta | Glatiramer acetate
Item
treatment with interferon beta or glatiramer acetate within 2 months of study initiation
boolean
C0015980 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
natalizumab | rituximab
Item
prior treatment with natalizumab or rituximab
boolean
C1172734 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
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