ID

43747

Description

A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01433250

Link

https://clinicaltrials.gov/show/NCT01433250

Keywords

Versions (2)
  1. 3/6/16 3/6/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT01433250

English

Eligibility Multiple Sclerosis NCT01433250

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. was exposed to ain457 or placebo in study cain457b2201 and completed the cain457b2201 study, up to at and including visit 10 (week 24).
Description

ain457; placebo

Data type

boolean

Alias
UMLS CUI [1]
C3179548
UMLS CUI [2]
C1696465
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have been treated with:
Description

therapy

Data type

boolean

Alias
UMLS CUI [1]
C0087111
immunosuppressive medications such as azathioprine or methotrexate within 1 month prior to enrollment, if lymphocyte count normal.
Description

Immunosuppressive Agents; azathioprine; methotrexate

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0004482
UMLS CUI [3]
C0025677
immunoglobulins and/or monoclonal antibodies (with the exception of ain457) within 2 month prior to enrollment, or if the immunosuppressive effects are likely to persist at enrollment (such as presence of b cell depletion after rituximab treatment).
Description

immunoglobulins; monoclonal antibodies; b lymphocyte depletion therapy; rituximab

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0003250
UMLS CUI [3]
C1171324
UMLS CUI [4]
C0393022
2. have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone or other immunosuppressive treatments with long-lasting (over 6 months) or permanent effects.
Description

Lymphatic Irradiation; alemtuzumab; cladribine; cyclophosphamide; mitoxantrone

Data type

boolean

Alias
UMLS CUI [1]
C0024230
UMLS CUI [2]
C0383429
UMLS CUI [3]
C0092801
UMLS CUI [4]
C0010583
UMLS CUI [5]
C0026259
3. have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment.
Description

Vaccines, Attenuated; measles vaccines ; Varicella-zoster vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0042211
UMLS CUI [2]
C0770689
UMLS CUI [3]
C1319755
4. a diagnosis of chronic disease of the immune system other than ms, or of an immunodeficiency syndrome.
Description

Chronic disease of immune system; immunodeficiency syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1290894
UMLS CUI [2]
C0021051
5. current severe depression.
Description

severe depression

Data type

boolean

Alias
UMLS CUI [1]
C0588008
6. pregnant or nursing (lactating) women.
Description

pregnancy; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin).
Description

malignancy; squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0553723
8. a new diagnosis of diabetes
Description

diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011849
9. positive testing for tuberculosis (quantiferon or chest x-ray).
Description

tuberculosis test

Data type

boolean

Alias
UMLS CUI [1]
C2242734
10. subjects with clinically significant cardiac abnormalities
Description

cardiac abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C0018798
11. unable or unwilling to undergo multiple venipunctures
Description

venipunctures

Data type

boolean

Alias
UMLS CUI [1]
C0600406
12. unable to undergo mri scans due to newly acquired claustrophobia or metallic implants incompatible with mri.
Description

mri; claustrophobia ; metallic implant

Data type

boolean

Alias
UMLS CUI [1]
C0024485
UMLS CUI [2]
C0008909
UMLS CUI [3]
C3693688
other protocol-defined inclusion/exclusion criteria may apply
Description

inclusion; exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0680251
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Similar models

Eligibility Multiple Sclerosis NCT01433250

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ain457; placebo
Item
1. was exposed to ain457 or placebo in study cain457b2201 and completed the cain457b2201 study, up to at and including visit 10 (week 24).
boolean
C3179548 (UMLS CUI [1])
C1696465 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
therapy
Item
1. have been treated with:
boolean
C0087111 (UMLS CUI [1])
Immunosuppressive Agents; azathioprine; methotrexate
Item
immunosuppressive medications such as azathioprine or methotrexate within 1 month prior to enrollment, if lymphocyte count normal.
boolean
C0021081 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
immunoglobulins; monoclonal antibodies; b lymphocyte depletion therapy; rituximab
Item
immunoglobulins and/or monoclonal antibodies (with the exception of ain457) within 2 month prior to enrollment, or if the immunosuppressive effects are likely to persist at enrollment (such as presence of b cell depletion after rituximab treatment).
boolean
C0021027 (UMLS CUI [1])
C0003250 (UMLS CUI [2])
C1171324 (UMLS CUI [3])
C0393022 (UMLS CUI [4])
Lymphatic Irradiation; alemtuzumab; cladribine; cyclophosphamide; mitoxantrone
Item
2. have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone or other immunosuppressive treatments with long-lasting (over 6 months) or permanent effects.
boolean
C0024230 (UMLS CUI [1])
C0383429 (UMLS CUI [2])
C0092801 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
C0026259 (UMLS CUI [5])
Vaccines, Attenuated; measles vaccines ; Varicella-zoster vaccine
Item
3. have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment.
boolean
C0042211 (UMLS CUI [1])
C0770689 (UMLS CUI [2])
C1319755 (UMLS CUI [3])
Chronic disease of immune system; immunodeficiency syndrome
Item
4. a diagnosis of chronic disease of the immune system other than ms, or of an immunodeficiency syndrome.
boolean
C1290894 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
severe depression
Item
5. current severe depression.
boolean
C0588008 (UMLS CUI [1])
pregnancy; lactating
Item
6. pregnant or nursing (lactating) women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
malignancy; squamous cell carcinoma of skin
Item
7. malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin).
boolean
C0006826 (UMLS CUI [1])
C0553723 (UMLS CUI [2])
diabetes
Item
8. a new diagnosis of diabetes
boolean
C0011849 (UMLS CUI [1])
tuberculosis test
Item
9. positive testing for tuberculosis (quantiferon or chest x-ray).
boolean
C2242734 (UMLS CUI [1])
cardiac abnormalities
Item
10. subjects with clinically significant cardiac abnormalities
boolean
C0018798 (UMLS CUI [1])
venipunctures
Item
11. unable or unwilling to undergo multiple venipunctures
boolean
C0600406 (UMLS CUI [1])
mri; claustrophobia ; metallic implant
Item
12. unable to undergo mri scans due to newly acquired claustrophobia or metallic implants incompatible with mri.
boolean
C0024485 (UMLS CUI [1])
C0008909 (UMLS CUI [2])
C3693688 (UMLS CUI [3])
inclusion; exclusion criteria
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
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