ID

37015

Description

Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis (MS) After Failure on Other Therapies; ODM derived from: https://clinicaltrials.gov/show/NCT02241785

Link

https://clinicaltrials.gov/show/NCT02241785

Keywords

Versions (1)
  1. 6/30/19 6/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 30, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Relapsing Multiple Sclerosis NCT02241785

English

Eligibility Relapsing Multiple Sclerosis NCT02241785

1 forms  
Criteria
Description

Criteria

subjects of childbearing potential must practice effective contraception from day -1 and be willing and able to continue contraception for duration of the study.
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
must have documented diagnosis of relapsing ms (mcdonald 2010 criteria [polman 2011]) at screening.
Description

Multiple sclerosis relapse

Data type

boolean

Alias
UMLS CUI [1]
C0856120
must have been treated with gilenya or bracet for at least the 12 months prior to screening with no interruption of treatment greater than 1 month. more than 1 prior disease-modifying therapy is allowed, as long as minimum treatment duration was cumulatively 12 months. prior treatment with natalizumab is allowed; however, there must be a minimum 1 year since last natalizumab infusion and the screening visit of this study, and if discontinuation of natalizumab in the past was not due to intolerance, anti-natalizumab antibodies, or efficacy loss.
Description

Gilenya | BRACET | Biological Response Modifier Therapy Quantity | Natalizumab Previous

Data type

boolean

Alias
UMLS CUI [1]
C2938762
UMLS CUI [2]
C0909411
UMLS CUI [3,1]
C0005527
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C1172734
UMLS CUI [4,2]
C0205156
must have had disease activity in the 6 months prior to screening while on gilenya or bracet (as defined by at least 1 gd+ lesion or at least 2 new t2 lesions (compared with an mri done within 12 months of screening) or clinical relapse, or edss progression of 1 point)
Description

Gadolinium-Enhancing Lesion Quantity | Lesion T2 Quantity | Relapse | EDSS Elevated

Data type

boolean

Alias
UMLS CUI [1,1]
C1333400
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C3472340
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0035020
UMLS CUI [4,1]
C0451246
UMLS CUI [4,2]
C3163633
must have an edss score from 0 to 5.5 inclusive at screening.
Description

EDSS

Data type

boolean

Alias
UMLS CUI [1]
C0451246
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
history or positive test result at screening for human immunodeficiency virus (hiv).
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
prior treatment with natalizumab (either commercially or through a clinical study) within 1 year of day -1.
Description

natalizumab

Data type

boolean

Alias
UMLS CUI [1]
C1172734
contraindications to treatment with natalizumab as described in the prescribing information for each of the participating countries.
Description

Medical contraindication Natalizumab

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1172734
known allergy to natalizumab or any of its ingredients, or known to be anti-natalizumab antibody positive.
Description

Hypersensitivity Natalizumab | Hypersensitivity Natalizumab Ingredient | Natalizumab Ab Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1172734
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1172734
UMLS CUI [2,3]
C1550600
UMLS CUI [3,1]
C1977362
UMLS CUI [3,2]
C1514241
diagnosis of primary progressive ms, secondary progressive ms, and/or progressive-relapsing ms.
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
an ms relapse that has occurred within the 30 days prior to day -1 and/or the subject has not stabilized from a previous relapse prior to day -1.
Description

Multiple sclerosis relapse | Relapse Previous | Stabilization Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0856120
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C1293130
UMLS CUI [3,2]
C0332268
known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
Description

Malignant Neoplasms | Exception Complete excision Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015250
UMLS CUI [2,3]
C0007117
history of severe opportunistic infections (including pml) or any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the investigator
Description

Opportunistic Infections Severe | Leukoencephalopathy, Progressive Multifocal | Heart Disease | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Nervous system disorder | Dermatologic disorders | Mental disorders | Kidney Diseases | Disease Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0029118
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0023524
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]
C0027765
UMLS CUI [12]
C0037274
UMLS CUI [13]
C0004936
UMLS CUI [14]
C0022658
UMLS CUI [15,1]
C0012634
UMLS CUI [15,2]
C0205164
females breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception; women who have a positive pregnancy test result at day -1.
Description

Breast Feeding | Pregnancy | Pregnancy, Planned | Postmenopausal state Absent | Female Sterilization Absent | Gender Contraceptive methods Unwilling | Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0232970
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0015787
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0700589
UMLS CUI [6,3]
C0558080
UMLS CUI [7]
C0240802
prior history of immunosuppressant use (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab) in the last 12 months prior to screening. prior history of alemtuzumab use at any point in the past.
Description

Immunosuppressive Agents | Mitoxantrone | Azathioprine | Methotrexate | Cyclophosphamide | MYCOPHENOLATE | Cladribine | rituximab | alemtuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0026259
UMLS CUI [3]
C0004482
UMLS CUI [4]
C0025677
UMLS CUI [5]
C0010583
UMLS CUI [6]
C0883242
UMLS CUI [7]
C0092801
UMLS CUI [8]
C0393022
UMLS CUI [9]
C0383429
note: other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Relapsing Multiple Sclerosis NCT02241785

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Childbearing Potential Contraceptive methods
Item
subjects of childbearing potential must practice effective contraception from day -1 and be willing and able to continue contraception for duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Multiple sclerosis relapse
Item
must have documented diagnosis of relapsing ms (mcdonald 2010 criteria [polman 2011]) at screening.
boolean
C0856120 (UMLS CUI [1])
Gilenya | BRACET | Biological Response Modifier Therapy Quantity | Natalizumab Previous
Item
must have been treated with gilenya or bracet for at least the 12 months prior to screening with no interruption of treatment greater than 1 month. more than 1 prior disease-modifying therapy is allowed, as long as minimum treatment duration was cumulatively 12 months. prior treatment with natalizumab is allowed; however, there must be a minimum 1 year since last natalizumab infusion and the screening visit of this study, and if discontinuation of natalizumab in the past was not due to intolerance, anti-natalizumab antibodies, or efficacy loss.
boolean
C2938762 (UMLS CUI [1])
C0909411 (UMLS CUI [2])
C0005527 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1172734 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
Gadolinium-Enhancing Lesion Quantity | Lesion T2 Quantity | Relapse | EDSS Elevated
Item
must have had disease activity in the 6 months prior to screening while on gilenya or bracet (as defined by at least 1 gd+ lesion or at least 2 new t2 lesions (compared with an mri done within 12 months of screening) or clinical relapse, or edss progression of 1 point)
boolean
C1333400 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C3472340 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0035020 (UMLS CUI [3])
C0451246 (UMLS CUI [4,1])
C3163633 (UMLS CUI [4,2])
EDSS
Item
must have an edss score from 0 to 5.5 inclusive at screening.
boolean
C0451246 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
HIV Seropositivity
Item
history or positive test result at screening for human immunodeficiency virus (hiv).
boolean
C0019699 (UMLS CUI [1])
natalizumab
Item
prior treatment with natalizumab (either commercially or through a clinical study) within 1 year of day -1.
boolean
C1172734 (UMLS CUI [1])
Medical contraindication Natalizumab
Item
contraindications to treatment with natalizumab as described in the prescribing information for each of the participating countries.
boolean
C1301624 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
Hypersensitivity Natalizumab | Hypersensitivity Natalizumab Ingredient | Natalizumab Ab Positive
Item
known allergy to natalizumab or any of its ingredients, or known to be anti-natalizumab antibody positive.
boolean
C0020517 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1172734 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
C1977362 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
diagnosis of primary progressive ms, secondary progressive ms, and/or progressive-relapsing ms.
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Multiple sclerosis relapse | Relapse Previous | Stabilization Lacking
Item
an ms relapse that has occurred within the 30 days prior to day -1 and/or the subject has not stabilized from a previous relapse prior to day -1.
boolean
C0856120 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1293130 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Malignant Neoplasms | Exception Complete excision Basal cell carcinoma
Item
known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015250 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
Opportunistic Infections Severe | Leukoencephalopathy, Progressive Multifocal | Heart Disease | Endocrine System Diseases | Hematological Disease | Liver diseases | Immune System Diseases | Metabolic Diseases | Urologic Diseases | Lung diseases | Nervous system disorder | Dermatologic disorders | Mental disorders | Kidney Diseases | Disease Major
Item
history of severe opportunistic infections (including pml) or any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the investigator
boolean
C0029118 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023524 (UMLS CUI [2])
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])
C0027765 (UMLS CUI [11])
C0037274 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
C0022658 (UMLS CUI [14])
C0012634 (UMLS CUI [15,1])
C0205164 (UMLS CUI [15,2])
Breast Feeding | Pregnancy | Pregnancy, Planned | Postmenopausal state Absent | Female Sterilization Absent | Gender Contraceptive methods Unwilling | Pregnancy test positive
Item
females breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception; women who have a positive pregnancy test result at day -1.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0232970 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0015787 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0079399 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
C0240802 (UMLS CUI [7])
Immunosuppressive Agents | Mitoxantrone | Azathioprine | Methotrexate | Cyclophosphamide | MYCOPHENOLATE | Cladribine | rituximab | alemtuzumab
Item
prior history of immunosuppressant use (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab) in the last 12 months prior to screening. prior history of alemtuzumab use at any point in the past.
boolean
C0021081 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0004482 (UMLS CUI [3])
C0025677 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
C0883242 (UMLS CUI [6])
C0092801 (UMLS CUI [7])
C0393022 (UMLS CUI [8])
C0383429 (UMLS CUI [9])
Eligibility Criteria Study Protocol
Item
note: other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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