ID

22916

Description

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

Keywords

Versions (1)
  1. 6/16/17 6/16/17 -
Uploaded on

June 16, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Relapsing Remitting Multiple Sclerosis NCT00242268

English

Eligibility Relapsing Remitting Multiple Sclerosis NCT00242268

1 forms  
Inclusion Criteria
Description

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.
Description

Age | Pregnancy Absent | Multiple Sclerosis, Relapsing-Remitting

Data type

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:
Description

Interferon therapy | Rebif | Avonex | Betaseron | Breakthrough Disease

Data type

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.
Description

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

Data type

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.
Description

Relapse | Relapse untreated

Data type

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.
Description

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

Data type

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.
Description

Kurtzke multiple sclerosis rating scale

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive

Data type

boolean

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

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

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.
Description

Gender Contraceptive methods | Rhythm method of contraception

Data type

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.
Description

Informed Consent Unwilling | Informed Consent Unable

Data type

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).
Description

Neutralizing Antibodies Positive Titer

Data type

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:
Description

Blood test abnormal

Data type

boolean

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

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

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

Creatine phosphokinase serum increased

Data type

boolean

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

Total white blood count

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0853112
UMLS CUI [3]
C0524909
UMLS CUI [4]
C0524910
Back to the top of the page

Similar models

Eligibility Relapsing Remitting Multiple Sclerosis NCT00242268

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial