ID

22916

Beschrijving

A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00242268

Link

https://clinicaltrials.gov/show/NCT00242268

Trefwoorden

Versies (1)
  1. 16-06-17 16-06-17 -
Geüploaded op

16 juni 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Relapsing Remitting Multiple Sclerosis NCT00242268

Engels

Eligibility Relapsing Remitting Multiple Sclerosis NCT00242268

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or non-pregnant females age 18-55 who have clinically and laboratory definite relapsing-remitting ms using the macdonald criteria.
Beschrijving

Age | Pregnancy Absent | Multiple Sclerosis, Relapsing-Remitting

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0751967
2. subjects must be taking some form of interferon therapy (rebif, avonex or betaseron) for a duration of 12 months with documented breakthrough disease as defined:
Beschrijving

Interferon therapy | Rebif | Avonex | Betaseron | Breakthrough Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0279030
UMLS CUI [2]
C0752980
UMLS CUI [3]
C0594372
UMLS CUI [4]
C0284968
UMLS CUI [5,1]
C0444503
UMLS CUI [5,2]
C0012634
or = 1 documented clinical relapse in past 12 months while on interferon therapy. for eligibility, a pre-study relapse is 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.
Beschrijving

Interferon therapy | Relapse Quantity | Neurological signs and symptoms Consistent with Multiple sclerosis relapse

Datatype

boolean

Alias
UMLS CUI [1]
C0279030
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0852414
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C0856120
the relapse does not need to have been treated to qualify. the timing of the relapse is defined based on the onset of symptoms.
Beschrijving

Relapse | Relapse untreated

Datatype

boolean

Alias
UMLS CUI [1]
C0035020
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0332155
> or = 1 documented gd-enhancing lesion on cranial or spinal mri. the presence of a gd-enhancing lesion must be documented either by a report in the medical record or review of the films by the investigator.
Beschrijving

Gadolinium-Enhancing Lesion Quantity MRI of head | Gadolinium-Enhancing Lesion Quantity MRI of Spinal Cord

Datatype

boolean

Alias
UMLS CUI [1,1]
C1333400
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0412674
UMLS CUI [2,1]
C1333400
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C2454646
3. the kurtzke edss score must be between 0- 5.0.
Beschrijving

Kurtzke multiple sclerosis rating scale

Datatype

boolean

Alias
UMLS CUI [1]
C0451246
4. all subjects must give written consent prior to evaluation and testing.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects with primary or secondary progressive ms.
Beschrijving

Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive

Datatype

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
2. female patients may not be pregnant, attempting pregnancy or breastfeeding.
Beschrijving

Pregnancy | Pregnancy, Planned | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
3. female subjects must use an acceptable form of contraception during the study as defined by the investigators. the rhythm method is not to be used as the sole method of contraception.
Beschrijving

Gender Contraceptive methods | Rhythm method of contraception

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0035513
4. subjects unwilling or unable to give informed consent.
Beschrijving

Informed Consent Unwilling | Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
5. subjects that are nab+ (titers > or = 20).
Beschrijving

Neutralizing Antibodies Positive Titer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475463
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0475208
6. abnormal baseline blood test exceeding any of the limits defined below:
Beschrijving

Blood test abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0854146
1. alt or ast > 2x upper limit of normal (uln)
Beschrijving

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
2. cpk > 2x upper limit of normal (uln)
Beschrijving

Creatine phosphokinase serum increased

Datatype

boolean

Alias
UMLS CUI [1]
C0241005
3. total wbc < 3,000/mm3
Beschrijving

Total white blood count

Datatype

boolean

Alias
UMLS CUI [1]
C1271681
7. no chronic infections (including hiv and hepatitis b/c) may be present.
Beschrijving

Chronic infectious disease | Chronic infection with HIV | Hepatitis B, Chronic | Hepatitis C, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0853112
UMLS CUI [3]
C0524909
UMLS CUI [4]
C0524910
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Similar models

Eligibility Relapsing Remitting Multiple Sclerosis NCT00242268

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Pregnancy Absent | Multiple Sclerosis, Relapsing-Remitting
Item
1. male or non-pregnant females age 18-55 who have clinically and laboratory definite relapsing-remitting ms using the macdonald criteria.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0751967 (UMLS CUI [3])
Interferon therapy | Rebif | Avonex | Betaseron | Breakthrough Disease
Item
2. subjects must be taking some form of interferon therapy (rebif, avonex or betaseron) for a duration of 12 months with documented breakthrough disease as defined:
boolean
C0279030 (UMLS CUI [1])
C0752980 (UMLS CUI [2])
C0594372 (UMLS CUI [3])
C0284968 (UMLS CUI [4])
C0444503 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
Interferon therapy | Relapse Quantity | Neurological signs and symptoms Consistent with Multiple sclerosis relapse
Item
or = 1 documented clinical relapse in past 12 months while on interferon therapy. for eligibility, a pre-study relapse is 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.
boolean
C0279030 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0852414 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0856120 (UMLS CUI [3,3])
Relapse | Relapse untreated
Item
the relapse does not need to have been treated to qualify. the timing of the relapse is defined based on the onset of symptoms.
boolean
C0035020 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Gadolinium-Enhancing Lesion Quantity MRI of head | Gadolinium-Enhancing Lesion Quantity MRI of Spinal Cord
Item
> or = 1 documented gd-enhancing lesion on cranial or spinal mri. the presence of a gd-enhancing lesion must be documented either by a report in the medical record or review of the films by the investigator.
boolean
C1333400 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0412674 (UMLS CUI [1,3])
C1333400 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C2454646 (UMLS CUI [2,3])
Kurtzke multiple sclerosis rating scale
Item
3. the kurtzke edss score must be between 0- 5.0.
boolean
C0451246 (UMLS CUI [1])
Informed Consent
Item
4. all subjects must give written consent prior to evaluation and testing.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive
Item
1. subjects with primary or secondary progressive ms.
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
2. female patients may not be pregnant, attempting pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Gender Contraceptive methods | Rhythm method of contraception
Item
3. female subjects must use an acceptable form of contraception during the study as defined by the investigators. the rhythm method is not to be used as the sole method of contraception.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0035513 (UMLS CUI [2])
Informed Consent Unwilling | Informed Consent Unable
Item
4. subjects unwilling or unable to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Neutralizing Antibodies Positive Titer
Item
5. subjects that are nab+ (titers > or = 20).
boolean
C0475463 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0475208 (UMLS CUI [1,3])
Blood test abnormal
Item
6. abnormal baseline blood test exceeding any of the limits defined below:
boolean
C0854146 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
1. alt or ast > 2x upper limit of normal (uln)
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Creatine phosphokinase serum increased
Item
2. cpk > 2x upper limit of normal (uln)
boolean
C0241005 (UMLS CUI [1])
Total white blood count
Item
3. total wbc < 3,000/mm3
boolean
C1271681 (UMLS CUI [1])
Chronic infectious disease | Chronic infection with HIV | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
7. no chronic infections (including hiv and hepatitis b/c) may be present.
boolean
C0151317 (UMLS CUI [1])
C0853112 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
C0524910 (UMLS CUI [4])
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