ID

23234

Descrição

The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00385697

Link

https://clinicaltrials.gov/show/NCT00385697

Palavras-chave

Versões (1)
  1. 29/06/2017 29/06/2017 -
Transferido a

29 de junho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT00385697

Inglês

Eligibility Type 1 Diabetes Mellitus NCT00385697

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must meet all of the following criteria:
Descrição

Criteria Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. enrollment (segment #1) or randomization (segment #2) on study day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. study day 0 is the first day of study drug dosing.
Descrição

Diabetes Mellitus Sign or Symptom

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C3540840
2. diagnosis of type 1 diabetes mellitus, according to the american diabetes association (ada) criteria
Descrição

Diabetes Mellitus, Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
3. requirement for injected insulin therapy
Descrição

Insulin injection Therapy Patient need for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0686904
4. have a detectable fasting or stimulated c-peptide level (above the lower limit of detection of the assay)
Descrição

Fasting C-peptide level Detectable | C-peptide stimulation test Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2208720
UMLS CUI [1,2]
C3830527
UMLS CUI [2,1]
C0430183
UMLS CUI [2,2]
C1514241
5. one positive result on testing for any of the following antibodies:
Descrição

Antibody test Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0580327
UMLS CUI [1,2]
C1514241
1. islet-cell autoantibodies (ica512/ia-2),
Descrição

autoantibodies to islet cells | ICA512

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2097865
UMLS CUI [2]
C0380315
2. glutamic acid decarboxylase autoantibodies, or
Descrição

Glutamic Acid Decarboxylase Autoantibodies

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0017785
UMLS CUI [1,2]
C0004358
3. insulin autoantibodies (if present during first 2 weeks, but not beyond 2 weeks, of insulin treatment)
Descrição

Insulin autoantibody | Insulin regime

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1275890
UMLS CUI [2]
C0557978
6. male or female
Descrição

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
7. subject must be in one of the following age groups:
Descrição

Age Group

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0441833
age 18-35 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
age 12-17 years pending approval by data monitoring committee
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
age 8-11 years pending approval by data monitoring committee
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
8. body weight ≥ 36 kg
Descrição

Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects must have none of the following:
Descrição

Criteria None

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0549184
1. prior administration of a monoclonal antibody -- within the 1 year before enrollment or randomization at study day 0 -- that could potentially prevent or confound a therapeutic response to mga031
Descrição

Monoclonal Antibody Therapy Preventing Disease Response | Monoclonal Antibody Therapy Interferes with Disease Response | MGA031

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279694
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1704632
UMLS CUI [2,1]
C0279694
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1704632
UMLS CUI [3]
C2987612
2. participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks before enrollment or randomization
Descrição

Study Subject Participation Status | Investigational New Drugs | Vaccines

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0042210
3. any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
Descrição

Medical condition Interferes with Completion of clinical trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
4. pregnant or lactating females
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. prior murine okt®3 treatment at any time before enrollment or randomization
Descrição

Muromonab-CD3

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085379
6. current or planned therapy with exenatide or any other agents that stimulate pancreatic beta cell regeneration or insulin secretion
Descrição

Exenatide | Exenatide Planned | Pharmaceutical Preparations Stimulating Pancreatic beta cell Regeneration | Pharmaceutical Preparations Stimulating Insulin secretion

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0167117
UMLS CUI [2,1]
C0167117
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1948023
UMLS CUI [3,3]
C0030281
UMLS CUI [3,4]
C0034963
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C1948023
UMLS CUI [4,3]
C1256369
7. current or planned therapy with inhaled insulin
Descrição

Insulin Inhaled | Insulin Inhaled Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0001559
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0001559
UMLS CUI [2,3]
C1301732
8. uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease, or other serious cardiac disease within the 12 weeks before enrollment or randomization
Descrição

Heart failure Uncompensated | Fluid overload | Myocardial Infarction | Myocardial Ischemia | Heart Disease Serious

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205433
UMLS CUI [2]
C0546817
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0151744
UMLS CUI [5,1]
C0018799
UMLS CUI [5,2]
C0205404
9. history of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or cerebrovascular disease
Descrição

Epilepsy | Malignant Neoplasms | Cystic Fibrosis | Anemia, Sickle Cell | Neuropathy | Peripheral Vascular Diseases | Cerebrovascular Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0010674
UMLS CUI [4]
C0002895
UMLS CUI [5]
C0442874
UMLS CUI [6]
C0085096
UMLS CUI [7]
C0007820
10. newly diagnosed hypothyroidism (not currently being treated but which, in the opinion of the investigator, should be treated) or active graves' disease
Descrição

Hypothyroidism Treatment required for | Graves Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020676
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C0018213
11. eczema, asthma or severe atopic disease requiring treatment within the 12 weeks before enrollment or randomization
Descrição

Eczema Treatment required for | Asthma Treatment required for | Atopic disorders Severe Treatment required for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013595
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C0947961
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0332121
12. evidence of active infection, such as fever ≥ 38.0 degrees celsius (100.5 degrees fahrenheit)
Descrição

Communicable Disease | Fever

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0015967
13. known or suspected infection with human immunodeficiency virus (hiv)
Descrição

HIV Infection | HIV Infection Suspected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0019693
UMLS CUI [2,2]
C0750491
14. evidence of active hepatitis b (hbv) or hepatitis c virus (hcv)
Descrição

Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
15. evidence of active or latent tuberculosis
Descrição

Tuberculosis | Latent Tuberculosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2]
C1609538
16. vaccination with a live virus within the 12 weeks before enrollment or randomization or planned live virus vaccination continuing through week 52 of the study. vaccination with an antigen or killed organism must not be given within 12 weeks before or planned within 8 weeks after each dosing cycle.
Descrição

Live Vaccines | Live Vaccines Planned | Vaccine Antigen | Vaccines, Inactivated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0042211
UMLS CUI [2,1]
C0042211
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C1519887
UMLS CUI [4]
C0042212
17. any infectious mononucleosis-like illness within the 6 months before enrollment or randomization
Descrição

Illness Infectious Mononucleosis Similar

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0021345
UMLS CUI [1,3]
C2348205
18. serologic and clinical evidence of acute infection with epstein-barr virus (ebv)
Descrição

Epstein-Barr Virus Infection Evidence Serologic | Epstein-Barr Virus Infection Evidence Clinical

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0149678
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205473
UMLS CUI [2,1]
C0149678
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C0205210
19. serologic evidence of acute infection with cytomegalovirus (cmv)
Descrição

Cytomegalovirus Infection Evidence Serologic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0010823
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205473
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Eligibility Type 1 Diabetes Mellitus NCT00385697

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
subjects must meet all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Diabetes Mellitus Sign or Symptom
Item
1. enrollment (segment #1) or randomization (segment #2) on study day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. study day 0 is the first day of study drug dosing.
boolean
C0011849 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
2. diagnosis of type 1 diabetes mellitus, according to the american diabetes association (ada) criteria
boolean
C0011854 (UMLS CUI [1])
Insulin injection Therapy Patient need for
Item
3. requirement for injected insulin therapy
boolean
C0199782 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
Fasting C-peptide level Detectable | C-peptide stimulation test Positive
Item
4. have a detectable fasting or stimulated c-peptide level (above the lower limit of detection of the assay)
boolean
C2208720 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0430183 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Antibody test Positive
Item
5. one positive result on testing for any of the following antibodies:
boolean
C0580327 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
autoantibodies to islet cells | ICA512
Item
1. islet-cell autoantibodies (ica512/ia-2),
boolean
C2097865 (UMLS CUI [1])
C0380315 (UMLS CUI [2])
Glutamic Acid Decarboxylase Autoantibodies
Item
2. glutamic acid decarboxylase autoantibodies, or
boolean
C0017785 (UMLS CUI [1,1])
C0004358 (UMLS CUI [1,2])
Insulin autoantibody | Insulin regime
Item
3. insulin autoantibodies (if present during first 2 weeks, but not beyond 2 weeks, of insulin treatment)
boolean
C1275890 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
Gender
Item
6. male or female
boolean
C0079399 (UMLS CUI [1])
Age Group
Item
7. subject must be in one of the following age groups:
boolean
C0001779 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Age
Item
age 18-35 years
boolean
C0001779 (UMLS CUI [1])
Age
Item
age 12-17 years pending approval by data monitoring committee
boolean
C0001779 (UMLS CUI [1])
Age
Item
age 8-11 years pending approval by data monitoring committee
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
8. body weight ≥ 36 kg
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria None
Item
subjects must have none of the following:
boolean
C0243161 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
Monoclonal Antibody Therapy Preventing Disease Response | Monoclonal Antibody Therapy Interferes with Disease Response | MGA031
Item
1. prior administration of a monoclonal antibody -- within the 1 year before enrollment or randomization at study day 0 -- that could potentially prevent or confound a therapeutic response to mga031
boolean
C0279694 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C0279694 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1704632 (UMLS CUI [2,3])
C2987612 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs | Vaccines
Item
2. participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks before enrollment or randomization
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
Medical condition Interferes with Completion of clinical trial
Item
3. any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
4. pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Muromonab-CD3
Item
5. prior murine okt®3 treatment at any time before enrollment or randomization
boolean
C0085379 (UMLS CUI [1])
Exenatide | Exenatide Planned | Pharmaceutical Preparations Stimulating Pancreatic beta cell Regeneration | Pharmaceutical Preparations Stimulating Insulin secretion
Item
6. current or planned therapy with exenatide or any other agents that stimulate pancreatic beta cell regeneration or insulin secretion
boolean
C0167117 (UMLS CUI [1])
C0167117 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C1948023 (UMLS CUI [3,2])
C0030281 (UMLS CUI [3,3])
C0034963 (UMLS CUI [3,4])
C0013227 (UMLS CUI [4,1])
C1948023 (UMLS CUI [4,2])
C1256369 (UMLS CUI [4,3])
Insulin Inhaled | Insulin Inhaled Planned
Item
7. current or planned therapy with inhaled insulin
boolean
C0021641 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0001559 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Heart failure Uncompensated | Fluid overload | Myocardial Infarction | Myocardial Ischemia | Heart Disease Serious
Item
8. uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease, or other serious cardiac disease within the 12 weeks before enrollment or randomization
boolean
C0018801 (UMLS CUI [1,1])
C0205433 (UMLS CUI [1,2])
C0546817 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C0018799 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
Epilepsy | Malignant Neoplasms | Cystic Fibrosis | Anemia, Sickle Cell | Neuropathy | Peripheral Vascular Diseases | Cerebrovascular Disorders
Item
9. history of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or cerebrovascular disease
boolean
C0014544 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0010674 (UMLS CUI [3])
C0002895 (UMLS CUI [4])
C0442874 (UMLS CUI [5])
C0085096 (UMLS CUI [6])
C0007820 (UMLS CUI [7])
Hypothyroidism Treatment required for | Graves Disease
Item
10. newly diagnosed hypothyroidism (not currently being treated but which, in the opinion of the investigator, should be treated) or active graves' disease
boolean
C0020676 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0018213 (UMLS CUI [2])
Eczema Treatment required for | Asthma Treatment required for | Atopic disorders Severe Treatment required for
Item
11. eczema, asthma or severe atopic disease requiring treatment within the 12 weeks before enrollment or randomization
boolean
C0013595 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0004096 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0947961 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0332121 (UMLS CUI [3,3])
Communicable Disease | Fever
Item
12. evidence of active infection, such as fever ≥ 38.0 degrees celsius (100.5 degrees fahrenheit)
boolean
C0009450 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
HIV Infection | HIV Infection Suspected
Item
13. known or suspected infection with human immunodeficiency virus (hiv)
boolean
C0019693 (UMLS CUI [1])
C0019693 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Hepatitis B | Hepatitis C
Item
14. evidence of active hepatitis b (hbv) or hepatitis c virus (hcv)
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Tuberculosis | Latent Tuberculosis
Item
15. evidence of active or latent tuberculosis
boolean
C0041296 (UMLS CUI [1])
C1609538 (UMLS CUI [2])
Live Vaccines | Live Vaccines Planned | Vaccine Antigen | Vaccines, Inactivated
Item
16. vaccination with a live virus within the 12 weeks before enrollment or randomization or planned live virus vaccination continuing through week 52 of the study. vaccination with an antigen or killed organism must not be given within 12 weeks before or planned within 8 weeks after each dosing cycle.
boolean
C0042211 (UMLS CUI [1])
C0042211 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1519887 (UMLS CUI [3])
C0042212 (UMLS CUI [4])
Illness Infectious Mononucleosis Similar
Item
17. any infectious mononucleosis-like illness within the 6 months before enrollment or randomization
boolean
C0221423 (UMLS CUI [1,1])
C0021345 (UMLS CUI [1,2])
C2348205 (UMLS CUI [1,3])
Epstein-Barr Virus Infection Evidence Serologic | Epstein-Barr Virus Infection Evidence Clinical
Item
18. serologic and clinical evidence of acute infection with epstein-barr virus (ebv)
boolean
C0149678 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
C0149678 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Cytomegalovirus Infection Evidence Serologic
Item
19. serologic evidence of acute infection with cytomegalovirus (cmv)
boolean
C0010823 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
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