ID

30953

Descrição

Clinical 15 Months Study Comparing Monthly Pulse ACTH (Acthar Gel) Therapy With Monthly Methylprednisolone (MP, Solumedrol) for Multiple Sclerosis (MS) Patients Who Are on Regular Beta-interferons (Avonex, Betaseron or Rebif); ODM derived from: https://clinicaltrials.gov/show/NCT01049451

Link

https://clinicaltrials.gov/show/NCT01049451

Palavras-chave

Versões (1)
  1. 07/07/2018 07/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de julho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT01049451

Inglês

Eligibility Multiple Sclerosis NCT01049451

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. clinically definite multiple sclerosis defined by mcdonald criteria.
Descrição

Multiple Sclerosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026769
2. between 18-65 years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
3. subject must able to understand and sign the irb- approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol, including self-administration of study drug (if assigned to the acth arm).
Descrição

Informed Consent | Protocol Compliance | Self Administration Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
UMLS CUI [3,1]
C0036589
UMLS CUI [3,2]
C0013230
4. subjects who are women of childbearing potential, must have a negative serum pregnancy test at the screening visit, and must be willing to practice a reliable birth-control method.
Descrição

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
5. subjects must have at least one ms relapse within last year and/or at least one new t2 or gadolinium-enhanced lesion on mri while on stable interferon therapy.
Descrição

Multiple sclerosis relapse Quantity | Lesion New Quantity MRI | Gadolinium-Enhancing Lesion Quantity MRI | Interferon therapy Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0024485
UMLS CUI [3,1]
C1333400
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0024485
UMLS CUI [4,1]
C0279030
UMLS CUI [4,2]
C0205360
6. edss (expanded disability status scale) score of 3.0 - 6.5
Descrição

EDSS

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451246
7. currently on one of the approved beta-interferon drugs (avonex, betaseron, or rebif) for a minimum of 6 months.
Descrição

Interferon-beta Pharmaceutical Preparations | Avonex | Betaseron | Rebif

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0015980
UMLS CUI [1,2]
C0013227
UMLS CUI [2]
C0594372
UMLS CUI [3]
C0284968
UMLS CUI [4]
C0752980
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women who are either pregnant or breastfeeding, and women of child-bearing potential (defined as not surgically sterile or at least two years post menopausal) who are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
Descrição

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Female Sterilization Absent | Postmenopausal state Absent | Tubal Ligation | Contraceptive implant | Contraceptives, Oral | Contraceptive patch | Contraceptive injection | Transdermal contraception | Contraception, Barrier | Sexual activity Restricted Partner had vasectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0015787
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0232970
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C0520483
UMLS CUI [7]
C1657106
UMLS CUI [8]
C0009905
UMLS CUI [9]
C2985284
UMLS CUI [10]
C1656586
UMLS CUI [11]
C1456475
UMLS CUI [12]
C0004764
UMLS CUI [13,1]
C0036864
UMLS CUI [13,2]
C0443288
UMLS CUI [13,3]
C0420842
2. uncontrolled hypertension, clinically significant cardiac arrhythmias, gastrointestinal ulcer, uncontrolled diabetes mellitus, osteoporosis, any stage of renal failure, psychiatric disorders or any other clinically significant general health conditions that may interfere with the trial participation.
Descrição

Uncontrolled hypertension | Cardiac Arrhythmia | Gastrointestinal ulcer | Diabetic - poor control | Osteoporosis | Kidney Failure Stage Any | Mental disorders | Health condition Interferes with Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0237938
UMLS CUI [4]
C0421258
UMLS CUI [5]
C0029456
UMLS CUI [6,1]
C0035078
UMLS CUI [6,2]
C1306673
UMLS CUI [6,3]
C1552551
UMLS CUI [7]
C0004936
UMLS CUI [8,1]
C2707304
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C2348568
3. subject has a history of drug or alcohol abuse within the past year.
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
4. subject had corticosteroid treatment within last 90 days.
Descrição

Steroid therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149783
5. subject started new medication within last 30 days.
Descrição

Pharmaceutical Preparation New Started

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C1272689
6. subject is on tysabri treatment presently or within 6 months of screening.
Descrição

Tysabri

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1529600
7. subject is on novantrone, cellcept, rituxan or other chemotherapeutic treatment presently or within 6 months of screening.
Descrição

Novantrone | Cellcept | Rituxan | Chemotherapeutic agent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0282248
UMLS CUI [2]
C0592558
UMLS CUI [3]
C0732355
UMLS CUI [4]
C0729502
8. subject is a participant in another research project.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
9. subject has contraindications for either acth or mp administration.
Descrição

Medical contraindication ACTH | Medical contraindication Methylprednisolone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001655
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0025815
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Similar models

Eligibility Multiple Sclerosis NCT01049451

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
1. clinically definite multiple sclerosis defined by mcdonald criteria.
boolean
C0026769 (UMLS CUI [1])
Age
Item
2. between 18-65 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance | Self Administration Investigational New Drugs
Item
3. subject must able to understand and sign the irb- approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol, including self-administration of study drug (if assigned to the acth arm).
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0036589 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
4. subjects who are women of childbearing potential, must have a negative serum pregnancy test at the screening visit, and must be willing to practice a reliable birth-control method.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Multiple sclerosis relapse Quantity | Lesion New Quantity MRI | Gadolinium-Enhancing Lesion Quantity MRI | Interferon therapy Stable
Item
5. subjects must have at least one ms relapse within last year and/or at least one new t2 or gadolinium-enhanced lesion on mri while on stable interferon therapy.
boolean
C0856120 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
C1333400 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C0279030 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
EDSS
Item
6. edss (expanded disability status scale) score of 3.0 - 6.5
boolean
C0451246 (UMLS CUI [1])
Interferon-beta Pharmaceutical Preparations | Avonex | Betaseron | Rebif
Item
7. currently on one of the approved beta-interferon drugs (avonex, betaseron, or rebif) for a minimum of 6 months.
boolean
C0015980 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0594372 (UMLS CUI [2])
C0284968 (UMLS CUI [3])
C0752980 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Female Sterilization Absent | Postmenopausal state Absent | Tubal Ligation | Contraceptive implant | Contraceptives, Oral | Contraceptive patch | Contraceptive injection | Transdermal contraception | Contraception, Barrier | Sexual activity Restricted Partner had vasectomy
Item
1. women who are either pregnant or breastfeeding, and women of child-bearing potential (defined as not surgically sterile or at least two years post menopausal) who are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0015787 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0232970 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0520483 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C0009905 (UMLS CUI [8])
C2985284 (UMLS CUI [9])
C1656586 (UMLS CUI [10])
C1456475 (UMLS CUI [11])
C0004764 (UMLS CUI [12])
C0036864 (UMLS CUI [13,1])
C0443288 (UMLS CUI [13,2])
C0420842 (UMLS CUI [13,3])
Uncontrolled hypertension | Cardiac Arrhythmia | Gastrointestinal ulcer | Diabetic - poor control | Osteoporosis | Kidney Failure Stage Any | Mental disorders | Health condition Interferes with Study Subject Participation Status
Item
2. uncontrolled hypertension, clinically significant cardiac arrhythmias, gastrointestinal ulcer, uncontrolled diabetes mellitus, osteoporosis, any stage of renal failure, psychiatric disorders or any other clinically significant general health conditions that may interfere with the trial participation.
boolean
C1868885 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0237938 (UMLS CUI [3])
C0421258 (UMLS CUI [4])
C0029456 (UMLS CUI [5])
C0035078 (UMLS CUI [6,1])
C1306673 (UMLS CUI [6,2])
C1552551 (UMLS CUI [6,3])
C0004936 (UMLS CUI [7])
C2707304 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
Substance Use Disorders
Item
3. subject has a history of drug or alcohol abuse within the past year.
boolean
C0038586 (UMLS CUI [1])
Steroid therapy
Item
4. subject had corticosteroid treatment within last 90 days.
boolean
C0149783 (UMLS CUI [1])
Pharmaceutical Preparation New Started
Item
5. subject started new medication within last 30 days.
boolean
C0013227 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1272689 (UMLS CUI [1,3])
Tysabri
Item
6. subject is on tysabri treatment presently or within 6 months of screening.
boolean
C1529600 (UMLS CUI [1])
Novantrone | Cellcept | Rituxan | Chemotherapeutic agent
Item
7. subject is on novantrone, cellcept, rituxan or other chemotherapeutic treatment presently or within 6 months of screening.
boolean
C0282248 (UMLS CUI [1])
C0592558 (UMLS CUI [2])
C0732355 (UMLS CUI [3])
C0729502 (UMLS CUI [4])
Study Subject Participation Status
Item
8. subject is a participant in another research project.
boolean
C2348568 (UMLS CUI [1])
Medical contraindication ACTH | Medical contraindication Methylprednisolone
Item
9. subject has contraindications for either acth or mp administration.
boolean
C1301624 (UMLS CUI [1,1])
C0001655 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0025815 (UMLS CUI [2,2])
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