ID

18285

Description

Efficacy and Safety of BG00012 in MS; ODM derived from: https://clinicaltrials.gov/show/NCT00168701

Link

https://clinicaltrials.gov/show/NCT00168701

Keywords

Versions (1)
  1. 10/27/16 10/27/16 -
Uploaded on

October 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00168701

English

Eligibility Multiple Sclerosis NCT00168701

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. must be 18 to 55 years old, inclusive, at the time of informed consent.
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
2. must have a confirmed diagnosis of relapsing-remitting ms according to mcdonald criteria #1-4 (mcdonald et al, 2001; appendix 2).
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

Alias
UMLS CUI [1]
C0751967
3. must have a baseline edss between 0.0 and 5.0, inclusive.
Description

EDSS

Data type

boolean

Alias
UMLS CUI [1]
C0451246
5. must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial mri demonstrating lesion(s) consistent with ms or show evidence of gd-enhancing lesions of the brain on an mri performed within the 6 weeks.
Description

Relapse Quantity | Cranium Magnetic Resonance Imaging | Lesion Consistent with Multiple Sclerosis | Gadolinium-Enhancing Lesion Brain Evidence of | Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1279062
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C0026769
UMLS CUI [4,1]
C1333400
UMLS CUI [4,2]
C0006104
UMLS CUI [4,3]
C0332120
UMLS CUI [5]
C0024485
6. male and female subjects must be willing to take appropriate measures to prevent pregnancy.
Description

Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. primary progressive, secondary progressive, or progressive relapsing ms (as defined by lublin and reingold, 1996 [appendix 3]).
Description

Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing

Data type

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
UMLS CUI [3]
C0393666
2. history of malignancy.
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
3. history of severe allergic or anaphylactic reactions or known drug hypersensitivity.
Description

severe allergic reaction | anaphylaxis Severe | Drug Allergy

Data type

boolean

Alias
UMLS CUI [1]
C2220378
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0013182
4. history of abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than ms), and/or other major disease.
Description

Laboratory Results Abnormal | Indication Disease Significant | Heart Diseases | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Gastrointestinal Diseases | Dermatologic disorders | Mental disorders | Kidney Diseases | nervous system disorder | Multiple Sclerosis | Disease Major

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0750502
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0014130
UMLS CUI [5]
C0018939
UMLS CUI [6]
C0023895
UMLS CUI [7]
C0021053
UMLS CUI [8]
C0025517
UMLS CUI [9]
C0042075
UMLS CUI [10]
C0024115
UMLS CUI [11]
C0017178
UMLS CUI [12]
C0037274
UMLS CUI [13]
C0004936
UMLS CUI [14]
C0022658
UMLS CUI [15]
C0027765
UMLS CUI [16]
C0026769
UMLS CUI [17,1]
C0012634
UMLS CUI [17,2]
C0205164
5. history of human immunodeficiency virus (hiv).
Description

HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019682
6. history of drug or alcohol abuse (as defined by the investigator) within the 2 years prior to randomization.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
7. an ms relapse that has occurred within the 50 days prior to randomization and/or the subject has not stabilized from a previous relapse prior to randomization.
Description

Multiple sclerosis relapse | Study Subject Stabilized

Data type

boolean

Alias
UMLS CUI [1]
C0856120
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0184512
8. body weight >100 kg.
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
9. positive for hepatitis c antibody and/or positive for hepatitis b surface antigen (hbsag) at screening.
Description

Hepatitis C antibody positive | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0281863
UMLS CUI [2]
C0149709
10. any of the following abnormal blood tests at screening.
Description

Blood test abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0854146
11. any previous treatment with fumaderm®, fag-201, or bg00012.
Description

Fumaderm | FAG 201 | BG 00012

Data type

boolean

Alias
UMLS CUI [1]
C0633802
UMLS CUI [2]
C1684381
UMLS CUI [3]
C1681886
12. a medication history that precludes entry into the study.
Description

Pharmaceutical Preparations Exclude Enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C1516879
13. female subjects who are currently pregnant or breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Multiple Sclerosis NCT00168701

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
1. must be 18 to 55 years old, inclusive, at the time of informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Multiple Sclerosis, Relapsing-Remitting
Item
2. must have a confirmed diagnosis of relapsing-remitting ms according to mcdonald criteria #1-4 (mcdonald et al, 2001; appendix 2).
boolean
C0751967 (UMLS CUI [1])
EDSS
Item
3. must have a baseline edss between 0.0 and 5.0, inclusive.
boolean
C0451246 (UMLS CUI [1])
Relapse Quantity | Cranium Magnetic Resonance Imaging | Lesion Consistent with Multiple Sclerosis | Gadolinium-Enhancing Lesion Brain Evidence of | Magnetic Resonance Imaging
Item
5. must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial mri demonstrating lesion(s) consistent with ms or show evidence of gd-enhancing lesions of the brain on an mri performed within the 6 weeks.
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1279062 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0026769 (UMLS CUI [3,3])
C1333400 (UMLS CUI [4,1])
C0006104 (UMLS CUI [4,2])
C0332120 (UMLS CUI [4,3])
C0024485 (UMLS CUI [5])
Gender Contraceptive methods
Item
6. male and female subjects must be willing to take appropriate measures to prevent pregnancy.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
1. primary progressive, secondary progressive, or progressive relapsing ms (as defined by lublin and reingold, 1996 [appendix 3]).
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Malignant Neoplasms
Item
2. history of malignancy.
boolean
C0006826 (UMLS CUI [1])
severe allergic reaction | anaphylaxis Severe | Drug Allergy
Item
3. history of severe allergic or anaphylactic reactions or known drug hypersensitivity.
boolean
C2220378 (UMLS CUI [1])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3])
Laboratory Results Abnormal | Indication Disease Significant | Heart Diseases | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Gastrointestinal Diseases | Dermatologic disorders | Mental disorders | Kidney Diseases | nervous system disorder | Multiple Sclerosis | Disease Major
Item
4. history of abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than ms), and/or other major disease.
boolean
C1254595 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0018799 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0021053 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
C0042075 (UMLS CUI [9])
C0024115 (UMLS CUI [10])
C0017178 (UMLS CUI [11])
C0037274 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
C0022658 (UMLS CUI [14])
C0027765 (UMLS CUI [15])
C0026769 (UMLS CUI [16])
C0012634 (UMLS CUI [17,1])
C0205164 (UMLS CUI [17,2])
HIV
Item
5. history of human immunodeficiency virus (hiv).
boolean
C0019682 (UMLS CUI [1])
Substance Use Disorders
Item
6. history of drug or alcohol abuse (as defined by the investigator) within the 2 years prior to randomization.
boolean
C0038586 (UMLS CUI [1])
Multiple sclerosis relapse | Study Subject Stabilized
Item
7. an ms relapse that has occurred within the 50 days prior to randomization and/or the subject has not stabilized from a previous relapse prior to randomization.
boolean
C0856120 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0184512 (UMLS CUI [2,2])
Body Weight
Item
8. body weight >100 kg.
boolean
C0005910 (UMLS CUI [1])
Hepatitis C antibody positive | Hepatitis B surface antigen positive
Item
9. positive for hepatitis c antibody and/or positive for hepatitis b surface antigen (hbsag) at screening.
boolean
C0281863 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Blood test abnormal
Item
10. any of the following abnormal blood tests at screening.
boolean
C0854146 (UMLS CUI [1])
Fumaderm | FAG 201 | BG 00012
Item
11. any previous treatment with fumaderm®, fag-201, or bg00012.
boolean
C0633802 (UMLS CUI [1])
C1684381 (UMLS CUI [2])
C1681886 (UMLS CUI [3])
Pharmaceutical Preparations Exclude Enrollment
Item
12. a medication history that precludes entry into the study.
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
13. female subjects who are currently pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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