ID

42654

Descrição

Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS); ODM derived from: https://clinicaltrials.gov/show/NCT02258217

Link

https://clinicaltrials.gov/show/NCT02258217

Palavras-chave

Versões (2)
  1. 29/06/2019 29/06/2019 -
  2. 17/09/2021 17/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

17 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Relapsing Remitting Multiple Sclerosis NCT02258217

Inglês

Eligibility Relapsing Remitting Multiple Sclerosis NCT02258217

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects who have volunteered and consented to participate in the study.
Descrição

Study Subject Participation Status Consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1511481
2. subjects who have no contraindication to taking high dose, oral prednisone or acthar.
Descrição

Medical contraindication Absent | Prednisone Oral Product High dose | Acthar Oral High dose

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3216040
UMLS CUI [2,2]
C0444956
UMLS CUI [3,1]
C0718234
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0444956
3. male or female subjects age 18 or greater years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
4. subjects with relapsing remitting multiple sclerosis (rrms) based on 2010 mcdonald criteria.
Descrição

Multiple Sclerosis, Relapsing-Remitting

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751967
5. subjects without an active infection (note: if a patient is found to have an uncomplicated uti and agrees to start on appropriate antibiotic treatment, they can continue in the study).
Descrição

Communicable Disease Absent | Antibiotics Urinary tract infection Uncomplicated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0003232
UMLS CUI [2,2]
C0042029
UMLS CUI [2,3]
C0443334
6. subjects who are experiencing a protocol defined ms relapse within two weeks of relapse onset.
Descrição

Multiple sclerosis relapse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0856120
7. subjects who are able and willing to sign a consent form.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects who are less than 18 years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. subjects with any contraindication to taking acthar.
Descrição

Medical contraindication Acthar

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0718234
3. subjects with an active infection other than an uncomplicated urinary tract infection (uti) (subjects determined to have a uti who agree to be treated with appropriate antibiotics will not be excluded).
Descrição

Communicable Disease | Exception Urinary tract infection Uncomplicated | Exception Antibiotics Urinary tract infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0042029
UMLS CUI [2,3]
C0443334
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0003232
UMLS CUI [3,3]
C0042029
4. subjects with an immune deficiency.
Descrição

Immunodeficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021051
5. subjects with a history of any of the following conditions: gastrointestinal ulcers, diabetes mellitus, gestational diabetes, malignant hypertension or steroid induced psychosis.
Descrição

Gastrointestinal ulcer | Diabetes Mellitus | Gestational Diabetes | Malignant Hypertension | PSYCHOSIS STEROID INDUCED

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0237938
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0085207
UMLS CUI [4]
C0020540
UMLS CUI [5]
C0748068
6. subjects who are pregnant or breastfeeding.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. subjects who are unable or unwilling to sign consent form.
Descrição

Informed Consent Unable | Informed Consent Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
8. patient is unable or unwilling to participate in phone and clinic follow up.
Descrição

Phone follow-up Unable | Phone follow-up Unwilling | Follow-up Unable | Follow-up Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0039457
UMLS CUI [1,2]
C1522577
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0039457
UMLS CUI [2,2]
C1522577
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C1522577
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C1522577
UMLS CUI [4,2]
C0558080
9. other factors that in the opinion of the principal investigator would exclude the subject from participation in the study.
Descrição

Factor Study Subject Participation Status Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
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Similar models

Eligibility Relapsing Remitting Multiple Sclerosis NCT02258217

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status Consent
Item
1. subjects who have volunteered and consented to participate in the study.
boolean
C2348568 (UMLS CUI [1,1])
C1511481 (UMLS CUI [1,2])
Medical contraindication Absent | Prednisone Oral Product High dose | Acthar Oral High dose
Item
2. subjects who have no contraindication to taking high dose, oral prednisone or acthar.
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3216040 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C0718234 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0444956 (UMLS CUI [3,3])
Age
Item
3. male or female subjects age 18 or greater years of age.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting
Item
4. subjects with relapsing remitting multiple sclerosis (rrms) based on 2010 mcdonald criteria.
boolean
C0751967 (UMLS CUI [1])
Communicable Disease Absent | Antibiotics Urinary tract infection Uncomplicated
Item
5. subjects without an active infection (note: if a patient is found to have an uncomplicated uti and agrees to start on appropriate antibiotic treatment, they can continue in the study).
boolean
C0009450 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003232 (UMLS CUI [2,1])
C0042029 (UMLS CUI [2,2])
C0443334 (UMLS CUI [2,3])
Multiple sclerosis relapse
Item
6. subjects who are experiencing a protocol defined ms relapse within two weeks of relapse onset.
boolean
C0856120 (UMLS CUI [1])
Informed Consent
Item
7. subjects who are able and willing to sign a consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. subjects who are less than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Medical contraindication Acthar
Item
2. subjects with any contraindication to taking acthar.
boolean
C1301624 (UMLS CUI [1,1])
C0718234 (UMLS CUI [1,2])
Communicable Disease | Exception Urinary tract infection Uncomplicated | Exception Antibiotics Urinary tract infection
Item
3. subjects with an active infection other than an uncomplicated urinary tract infection (uti) (subjects determined to have a uti who agree to be treated with appropriate antibiotics will not be excluded).
boolean
C0009450 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0042029 (UMLS CUI [2,2])
C0443334 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0003232 (UMLS CUI [3,2])
C0042029 (UMLS CUI [3,3])
Immunodeficiency
Item
4. subjects with an immune deficiency.
boolean
C0021051 (UMLS CUI [1])
Gastrointestinal ulcer | Diabetes Mellitus | Gestational Diabetes | Malignant Hypertension | PSYCHOSIS STEROID INDUCED
Item
5. subjects with a history of any of the following conditions: gastrointestinal ulcers, diabetes mellitus, gestational diabetes, malignant hypertension or steroid induced psychosis.
boolean
C0237938 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0085207 (UMLS CUI [3])
C0020540 (UMLS CUI [4])
C0748068 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
6. subjects who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Informed Consent Unable | Informed Consent Unwilling
Item
7. subjects who are unable or unwilling to sign consent form.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Phone follow-up Unable | Phone follow-up Unwilling | Follow-up Unable | Follow-up Unwilling
Item
8. patient is unable or unwilling to participate in phone and clinic follow up.
boolean
C0039457 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0039457 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1522577 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C1522577 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Factor Study Subject Participation Status Excluded
Item
9. other factors that in the opinion of the principal investigator would exclude the subject from participation in the study.
boolean
C1521761 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
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