ID

12839

Description

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00004814

Link

https://clinicaltrials.gov/show/NCT00004814

Keywords

Versions (1)
  1. 12/29/15 12/29/15 -
Uploaded on

December 29, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00004814

English

Eligibility Multiple Sclerosis NCT00004814

1 forms  
Criteria
Description

Criteria

clinically or laboratory-supported definite multiple sclerosis
Description

clinically or laboratory-supported definite multiple sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0026769
neurologically stable for at least 30 days prior to entry expanded disability status scale score no greater than 5
Description

neurologically stable for at least 30 days prior to entry expanded disability status scale score no greater than 5

Data type

boolean

Alias
UMLS CUI [1]
C0746866
UMLS CUI [2]
C3830336
at least 2 documented relapses within 2 years prior to entry onset of first relapse at least 1 year prior to randomization
Description

at least 2 documented relapses within 2 years prior to entry onset of first relapse at least 1 year prior to randomization

Data type

boolean

Alias
UMLS CUI [1]
C0277556
biologic therapy: no prior copolymer 1
Description

biologic therapy: no prior copolymer 1

Data type

boolean

Alias
UMLS CUI [1]
C0005527
immunosuppressive therapy: no prior cytotoxic immunosuppressives, i.e.: azathioprine cyclophosphamide cyclosporine at least 30 days since corticosteroids
Description

immunosuppressive therapy: no prior cytotoxic immunosuppressives, i.e.: azathioprine cyclophosphamide cyclosporine at least 30 days since corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0004482
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0010592
radiotherapy: no prior lymphoid irradiation
Description

radiotherapy: no prior lymphoid irradiation

Data type

boolean

Alias
UMLS CUI [1]
C0024230
not hiv or htlv-i seropositive no insulin-dependent diabetes mellitus no lyme disease no requirement for aspirin or chronic nonsteroidal anti-inflammatory drugs no pregnant or nursing women adequate contraception required of fertile women
Description

not hiv or htlv-i seropositive no insulin-dependent diabetes mellitus no lyme disease no requirement for aspirin or chronic nonsteroidal anti-inflammatory drugs no pregnant or nursing women adequate contraception required of fertile women

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0020094
UMLS CUI [3]
C0011854
UMLS CUI [4]
C0024198
UMLS CUI [5]
C0003211
UMLS CUI [6]
C0032961
UMLS CUI [7]
C0006147
UMLS CUI [8]
C1999124
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Similar models

Eligibility Multiple Sclerosis NCT00004814

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
multiple sclerosis
Item
clinically or laboratory-supported definite multiple sclerosis
boolean
C0026769 (UMLS CUI [1])
neurological status
Item
neurologically stable for at least 30 days prior to entry expanded disability status scale score no greater than 5
boolean
C0746866 (UMLS CUI [1])
C3830336 (UMLS CUI [2])
relapses
Item
at least 2 documented relapses within 2 years prior to entry onset of first relapse at least 1 year prior to randomization
boolean
C0277556 (UMLS CUI [1])
biologic therapy
Item
biologic therapy: no prior copolymer 1
boolean
C0005527 (UMLS CUI [1])
immunosuppressive therapy
Item
immunosuppressive therapy: no prior cytotoxic immunosuppressives, i.e.: azathioprine cyclophosphamide cyclosporine at least 30 days since corticosteroids
boolean
C0021079 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
radiotherapy
Item
radiotherapy: no prior lymphoid irradiation
boolean
C0024230 (UMLS CUI [1])
patient characteristics
Item
not hiv or htlv-i seropositive no insulin-dependent diabetes mellitus no lyme disease no requirement for aspirin or chronic nonsteroidal anti-inflammatory drugs no pregnant or nursing women adequate contraception required of fertile women
boolean
C0019682 (UMLS CUI [1])
C0020094 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
C0024198 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
C0032961 (UMLS CUI [6])
C0006147 (UMLS CUI [7])
C1999124 (UMLS CUI [8])
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