ID

22394

Beschreibung

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One; ODM derived from: https://clinicaltrials.gov/show/NCT00530348

Link

https://clinicaltrials.gov/show/NCT00530348

Stichworte

Versionen (1)
  1. 01.06.17 01.06.17 -
Hochgeladen am

1. Juni 2017

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00530348

Englisch

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00530348

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
given written/signed informed consent
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
age 18 to 50 years old (inclusive) as of the date the informed consent form (icf) was signed
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of ms per updated mcdonald criteria, and cranial magnetic resonance imaging (mri) scan demonstrating white matter lesions attributable to ms within 5 years of screening
Beschreibung

multiple sclerosis, diagnosis criteria, mri brain

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0679228
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C2675929
onset of ms symptoms (as determined by a neurologist, either at screening or retrospectively) within 5 years of the date the icf was signed
Beschreibung

onset of symptoms, multiple sclerosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277793
UMLS CUI [1,2]
C0026769
expanded disability status scale (edss) score 0.0 to 3.0 (inclusive) at screening
Beschreibung

edss

Datentyp

boolean

Alias
UMLS CUI [1]
C0451246
greater than or equal to (>=) 2 ms attacks (first episode or relapse) occurring in the 24 months prior to the date the icf was signed, with >=1 attack in the 12 months prior to the date the icf was signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other genzyme-approved health-care provider and the objective signs could be identified retrospectively
Beschreibung

ms attacks, quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
received prior therapy for ms other than corticosteroids, for example, alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, and mitoxantrone
Beschreibung

prior therapy alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, mitoxantrone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0383429
UMLS CUI [1,3]
C0021747
UMLS CUI [1,4]
C0085297
UMLS CUI [1,5]
C0289884
UMLS CUI [1,6]
C1172734
UMLS CUI [1,7]
C0026259
UMLS CUI [2]
C0149783
exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine a, methotrexate, or any other immunosuppressive agent other than systemic corticosteroid treatment
Beschreibung

exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine a, methotrexate, or any other immunosuppressive agent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0004482
UMLS CUI [1,3]
C0092801
UMLS CUI [1,4]
C0010583
UMLS CUI [1,5]
C0010592
UMLS CUI [1,6]
C0025677
UMLS CUI [1,7]
C0021081
UMLS CUI [2]
C0149783
any progressive form of ms
Beschreibung

progressive ms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0751964
UMLS CUI [1,2]
C0751965
history of malignancy (except basal skin cell carcinoma)
Beschreibung

history of malignancy, basal skin cell carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2735088
UMLS CUI [2]
C0007117
cd4 + , cd8 + count, b cell, or absolute neutrophil count less than (<) lower limit of normal (lln) at screening
Beschreibung

cd4 + , cd8 + count, b cell, or absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C1277776
UMLS CUI [2]
C1277777
UMLS CUI [3]
C1303089
UMLS CUI [4]
C0948762
known bleeding disorder (for example, dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, or clotting factor deficiency)
Beschreibung

bleeding disorder, dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, clotting factor deficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C1260903
UMLS CUI [3]
C0008533
UMLS CUI [4]
C0019069
UMLS CUI [5]
C0042974
UMLS CUI [6]
C0012739
UMLS CUI [7]
C0553681
UMLS CUI [8]
C0272315
significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
Beschreibung

autoimmune disease, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, connective tissue disorders, vasculitis, inflammatory bowel disease, psoriasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C3274706
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0024141
UMLS CUI [5]
C0009782
UMLS CUI [6]
C0042384
UMLS CUI [7]
C0021390
UMLS CUI [8]
C0033860
presence of anti-thyroid stimulating hormone (tsh) receptor (tshr) antibodies (that is, above the lln)
Beschreibung

TSH receptor antibodies

Datentyp

boolean

Alias
UMLS CUI [1]
C0201514
active infection or at high risk for infection
Beschreibung

active infection or at high risk for infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0009450
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Ähnliche Modelle

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00530348

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
given written/signed informed consent
boolean
C0021430 (UMLS CUI [1])
age
Item
age 18 to 50 years old (inclusive) as of the date the informed consent form (icf) was signed
boolean
C0001779 (UMLS CUI [1])
multiple sclerosis, diagnosis criteria, mri brain
Item
diagnosis of ms per updated mcdonald criteria, and cranial magnetic resonance imaging (mri) scan demonstrating white matter lesions attributable to ms within 5 years of screening
boolean
C0026769 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C2675929 (UMLS CUI [2,2])
onset of symptoms, multiple sclerosis
Item
onset of ms symptoms (as determined by a neurologist, either at screening or retrospectively) within 5 years of the date the icf was signed
boolean
C0277793 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
edss
Item
expanded disability status scale (edss) score 0.0 to 3.0 (inclusive) at screening
boolean
C0451246 (UMLS CUI [1])
ms attacks, quantity
Item
greater than or equal to (>=) 2 ms attacks (first episode or relapse) occurring in the 24 months prior to the date the icf was signed, with >=1 attack in the 12 months prior to the date the icf was signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other genzyme-approved health-care provider and the objective signs could be identified retrospectively
boolean
C0856120 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
prior therapy alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, mitoxantrone
Item
received prior therapy for ms other than corticosteroids, for example, alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, and mitoxantrone
boolean
C1514463 (UMLS CUI [1,1])
C0383429 (UMLS CUI [1,2])
C0021747 (UMLS CUI [1,3])
C0085297 (UMLS CUI [1,4])
C0289884 (UMLS CUI [1,5])
C1172734 (UMLS CUI [1,6])
C0026259 (UMLS CUI [1,7])
C0149783 (UMLS CUI [2])
exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine a, methotrexate, or any other immunosuppressive agent
Item
exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine a, methotrexate, or any other immunosuppressive agent other than systemic corticosteroid treatment
boolean
C0332157 (UMLS CUI [1,1])
C0004482 (UMLS CUI [1,2])
C0092801 (UMLS CUI [1,3])
C0010583 (UMLS CUI [1,4])
C0010592 (UMLS CUI [1,5])
C0025677 (UMLS CUI [1,6])
C0021081 (UMLS CUI [1,7])
C0149783 (UMLS CUI [2])
progressive ms
Item
any progressive form of ms
boolean
C0751964 (UMLS CUI [1,1])
C0751965 (UMLS CUI [1,2])
history of malignancy, basal skin cell carcinoma
Item
history of malignancy (except basal skin cell carcinoma)
boolean
C2735088 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
cd4 + , cd8 + count, b cell, or absolute neutrophil count
Item
cd4 + , cd8 + count, b cell, or absolute neutrophil count less than (<) lower limit of normal (lln) at screening
boolean
C1277776 (UMLS CUI [1])
C1277777 (UMLS CUI [2])
C1303089 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
bleeding disorder, dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, clotting factor deficiency
Item
known bleeding disorder (for example, dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, or clotting factor deficiency)
boolean
C0005779 (UMLS CUI [1])
C1260903 (UMLS CUI [2])
C0008533 (UMLS CUI [3])
C0019069 (UMLS CUI [4])
C0042974 (UMLS CUI [5])
C0012739 (UMLS CUI [6])
C0553681 (UMLS CUI [7])
C0272315 (UMLS CUI [8])
autoimmune disease, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, connective tissue disorders, vasculitis, inflammatory bowel disease, psoriasis
Item
significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
boolean
C0004364 (UMLS CUI [1])
C3274706 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0009782 (UMLS CUI [5])
C0042384 (UMLS CUI [6])
C0021390 (UMLS CUI [7])
C0033860 (UMLS CUI [8])
TSH receptor antibodies
Item
presence of anti-thyroid stimulating hormone (tsh) receptor (tshr) antibodies (that is, above the lln)
boolean
C0201514 (UMLS CUI [1])
active infection or at high risk for infection
Item
active infection or at high risk for infection
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0332167 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
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