ID

21971

Description

Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00324506

Link

https://clinicaltrials.gov/show/NCT00324506

Keywords

Versions (2)
  1. 5/11/17 5/11/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

May 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00324506

English

Eligibility Multiple Sclerosis NCT00324506

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient diagnosed with clinically definite ms according to mcdonald criteria #1-#4
Description

Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0026769
age 18-55
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have a rr disease course
Description

Disease Relapsing-remitting course

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3808177
have edss scores less than or equal to 5.0
Description

Kurtzke multiple sclerosis rating scale

Data type

boolean

Alias
UMLS CUI [1]
C0451246
have a disease duration of one day to 20 years
Description

disease length

Data type

boolean

Alias
UMLS CUI [1]
C0872146
have at least one medically documented clinical relapse within the 12 months prior to randomization (for eligibility, a pre-study relapse will be defined as neurologic symptoms and signs documented by review of the history with the subject or in the medical record, of sufficient severity and duration to be determined by the investigator as consistent with an acute ms relapse; the relapse does not need to have been treated to qualify) and/or have progression of ≥1.0 points in edss in the previous year
Description

Relapse Quantity | Relapse Neurologic Manifestations | Relapse Consistent with Acute Relapsing Multiple Sclerosis | Relapse Progression Kurtzke multiple sclerosis rating scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0027854
UMLS CUI [3,1]
C0035020
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C0393664
UMLS CUI [4,1]
C0035020
UMLS CUI [4,2]
C0242656
UMLS CUI [4,3]
C0451246
have ≥1 gd-enhancing brain lesion on a monthly run-in baseline mri and ≥2 t2 brain lesions consistent with ms on the screening scan
Description

Brain Gadolinium-Enhancing Lesion Quantity MRI | Lesion of brain Quantity MRI T2 weighted | Lesion of brain Consistent with Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0006104
UMLS CUI [1,2]
C1333400
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0024485
UMLS CUI [2,1]
C0221505
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C2238849
UMLS CUI [3,1]
C0221505
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C0026769
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
none of the exclusion criteria
Description

Exclusion Criteria omitted

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0750563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment 3 months prior to study entry with standard disease-modifying therapy (interferon-beta and glatiramer acetate, ivig and plasmaphoresis).
Description

Standard therapy Disease Modification | Interferon-beta | glatiramer acetate | Immunoglobulins, Intravenous | Plasmapheresis

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0392747
UMLS CUI [2]
C0015980
UMLS CUI [3]
C0289884
UMLS CUI [4]
C0085297
UMLS CUI [5]
C0032134
previous treatment 12 months prior to study entry with immunosuppressant agents, e.g., mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine or total body irradiation or any other concomitant immunomodulatory therapies (e.g., azathioprine, methotrexate,, cellcept®, natalizumab, and other immunomodulators/monoclonal agents).
Description

Immunosuppressive Agents | Mitoxantrone | Cyclophosphamide | Cladribine | fludarabine | Cyclosporine | Whole-Body Irradiation | Immunomodulation | Azathioprine | Methotrexate | Cellcept | natalizumab | Immunomodulators | Monoclonal antibody preparation

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0026259
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0092801
UMLS CUI [5]
C0059985
UMLS CUI [6]
C0010592
UMLS CUI [7]
C0043162
UMLS CUI [8]
C1963758
UMLS CUI [9]
C0004482
UMLS CUI [10]
C0025677
UMLS CUI [11]
C0592558
UMLS CUI [12]
C1172734
UMLS CUI [13]
C1527392
UMLS CUI [14]
C1298636
patients who received steroid treatment 30 days prior to the mri scan date
Description

Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0149783
women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
abnormal blood tests, performed during the screening visit (see adverse events section)
Description

Blood test abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0854146
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Similar models

Eligibility Multiple Sclerosis NCT00324506

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
patient diagnosed with clinically definite ms according to mcdonald criteria #1-#4
boolean
C0026769 (UMLS CUI [1])
Age
Item
age 18-55
boolean
C0001779 (UMLS CUI [1])
Disease Relapsing-remitting course
Item
have a rr disease course
boolean
C0012634 (UMLS CUI [1,1])
C3808177 (UMLS CUI [1,2])
Kurtzke multiple sclerosis rating scale
Item
have edss scores less than or equal to 5.0
boolean
C0451246 (UMLS CUI [1])
disease length
Item
have a disease duration of one day to 20 years
boolean
C0872146 (UMLS CUI [1])
Relapse Quantity | Relapse Neurologic Manifestations | Relapse Consistent with Acute Relapsing Multiple Sclerosis | Relapse Progression Kurtzke multiple sclerosis rating scale
Item
have at least one medically documented clinical relapse within the 12 months prior to randomization (for eligibility, a pre-study relapse will be defined as neurologic symptoms and signs documented by review of the history with the subject or in the medical record, of sufficient severity and duration to be determined by the investigator as consistent with an acute ms relapse; the relapse does not need to have been treated to qualify) and/or have progression of ≥1.0 points in edss in the previous year
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0035020 (UMLS CUI [2,1])
C0027854 (UMLS CUI [2,2])
C0035020 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0393664 (UMLS CUI [3,3])
C0035020 (UMLS CUI [4,1])
C0242656 (UMLS CUI [4,2])
C0451246 (UMLS CUI [4,3])
Brain Gadolinium-Enhancing Lesion Quantity MRI | Lesion of brain Quantity MRI T2 weighted | Lesion of brain Consistent with Multiple Sclerosis
Item
have ≥1 gd-enhancing brain lesion on a monthly run-in baseline mri and ≥2 t2 brain lesions consistent with ms on the screening scan
boolean
C0006104 (UMLS CUI [1,1])
C1333400 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
C0221505 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C2238849 (UMLS CUI [2,3])
C0221505 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0026769 (UMLS CUI [3,3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria omitted
Item
none of the exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0750563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Standard therapy Disease Modification | Interferon-beta | glatiramer acetate | Immunoglobulins, Intravenous | Plasmapheresis
Item
previous treatment 3 months prior to study entry with standard disease-modifying therapy (interferon-beta and glatiramer acetate, ivig and plasmaphoresis).
boolean
C2936643 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0015980 (UMLS CUI [2])
C0289884 (UMLS CUI [3])
C0085297 (UMLS CUI [4])
C0032134 (UMLS CUI [5])
Immunosuppressive Agents | Mitoxantrone | Cyclophosphamide | Cladribine | fludarabine | Cyclosporine | Whole-Body Irradiation | Immunomodulation | Azathioprine | Methotrexate | Cellcept | natalizumab | Immunomodulators | Monoclonal antibody preparation
Item
previous treatment 12 months prior to study entry with immunosuppressant agents, e.g., mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine or total body irradiation or any other concomitant immunomodulatory therapies (e.g., azathioprine, methotrexate,, cellcept®, natalizumab, and other immunomodulators/monoclonal agents).
boolean
C0021081 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0092801 (UMLS CUI [4])
C0059985 (UMLS CUI [5])
C0010592 (UMLS CUI [6])
C0043162 (UMLS CUI [7])
C1963758 (UMLS CUI [8])
C0004482 (UMLS CUI [9])
C0025677 (UMLS CUI [10])
C0592558 (UMLS CUI [11])
C1172734 (UMLS CUI [12])
C1527392 (UMLS CUI [13])
C1298636 (UMLS CUI [14])
Steroid therapy
Item
patients who received steroid treatment 30 days prior to the mri scan date
boolean
C0149783 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling
Item
women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Blood test abnormal
Item
abnormal blood tests, performed during the screening visit (see adverse events section)
boolean
C0854146 (UMLS CUI [1])
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