ID

35748

Descripción

EDCR Study - Etanercept Diamyd Combination Regimen -Open Trial to Evaluate Safety in Children With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02464033

Link

https://clinicaltrials.gov/show/NCT02464033

Palabras clave

Versiones (1)
  1. 20/3/19 20/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de marzo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT02464033

Inglés

Eligibility Diabetes Mellitus, Type 1 NCT02464033

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. informed consent given by patients and parent(s)/legal guardian(s)
Descripción

Informed Consent | Informed Consent Parent | Informed Consent Guardian

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
2. type 1 diabetes according to the ada classification, diagnosed within the previous 100 days at the time of screening
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
3. age 8.00 -17.99 years at time of screening
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
4. fasting c-peptide at time of screening ≥0.12 nmol/l
Descripción

Fasting C-peptide level

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2208720
5. positive for gada but < 50 000 units
Descripción

Anti-GAD antibody positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1167896
6. menarchal females must agree to avoid pregnancy and have a negative urine pregnancy test
Descripción

Gender Menarche Avoidance Pregnancy | Gender Menarche Urine pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0025274
UMLS CUI [1,3]
C0870186
UMLS CUI [1,4]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0025274
UMLS CUI [2,3]
C0430057
7. immunity against varicella, either through previous infection or vaccination
Descripción

Immunity Chickenpox | Communicable Disease Previous | Vaccination Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020964
UMLS CUI [1,2]
C0008049
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0042196
UMLS CUI [3,2]
C0205156
8. patients must follow the swedish vaccination programme
Descripción

Adherence Vaccination Program Swedish

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C3484370
UMLS CUI [1,4]
C1710263
9. patients of childbearing potential must agree to using adequate contraception, if sexually active, until 1 year after the last administration of gad-alum and etanercept. adequate contraception is as follows:
Descripción

Childbearing Potential Sexually active Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
for females of childbearing potential:
Descripción

Gender Childbearing Potential

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
1. oral (except low-dose gestagen (lynestrenol and norestisteron), injectable, or implanted hormonal contraceptives (females)
Descripción

Contraceptives, Oral, Hormonal | Exception Progestins Low dose | Exception Lynestrenol Low dose | Exception Norethindrone Low dose | Injectable contraception Hormonal | Contraceptive implant Hormonal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009907
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0033306
UMLS CUI [2,3]
C0445550
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024321
UMLS CUI [3,3]
C0445550
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0028356
UMLS CUI [4,3]
C0445550
UMLS CUI [5,1]
C1262153
UMLS CUI [5,2]
C0458083
UMLS CUI [6,1]
C1657106
UMLS CUI [6,2]
C0458083
2. intrauterine device (females)
Descripción

Intrauterine Devices

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021900
3. intrauterine system (for example, progestin-releasing coil) (females)
Descripción

Intrauterine System | Contraceptive coil Progestin Releasing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4293370
UMLS CUI [2,1]
C0419518
UMLS CUI [2,2]
C0033306
UMLS CUI [2,3]
C1283071
4. vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate)
Descripción

Vasectomy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042387
for males of childbearing potential:
Descripción

Gender Childbearing Potential

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
a. condom (male)
Descripción

Condoms, Male

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009653
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
Descripción

Immunosuppressant drug therapy | Topical Steroid Therapy Accepted | Inhaled steroids Accepted

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1096650
UMLS CUI [2,1]
C3897353
UMLS CUI [2,2]
C1272684
UMLS CUI [3,1]
C2065041
UMLS CUI [3,2]
C1272684
2. continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
Descripción

Anti-Inflammatory Agents Continuous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003209
UMLS CUI [1,2]
C0549178
3. treatment with any oral or injected anti-diabetic medications (especially hypoglycemic agents) other than insulin
Descripción

Antidiabetics Oral | Antidiabetics Injection | Hypoglycemic Agents | Exception Insulin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1828121
UMLS CUI [3]
C0020616
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0021641
4. treatment with vitamin d, marketed or not, or unwilling to abstain from such medication during the trial
Descripción

Vitamin D | Vitamin D Discontinue Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042866
UMLS CUI [2,1]
C0042866
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
5. a history of hypercalcemia
Descripción

Hypercalcemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020437
6. a history of anaemia or significantly abnormal haematology results at screening
Descripción

Anemia | Abnormal Hematology Test Result

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C1332130
7. a history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles
Descripción

Epilepsy | Craniocerebral Trauma | Cerebrovascular accident | Feature Continuous motor unit activity Proximal Muscle

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0018674
UMLS CUI [3]
C0038454
UMLS CUI [4,1]
C2348519
UMLS CUI [4,2]
C0429352
UMLS CUI [4,3]
C2984223
8. clinically significant history of acute reaction to vaccines or other drugs in the past
Descripción

Acute allergic reaction Vaccines | Drug Allergy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0413234
UMLS CUI [1,2]
C0042210
UMLS CUI [2]
C0013182
9. treatment with any vaccine within 4 months prior to planned first administration of gad-alum or planned treatment with vaccine up to 4 months after the last injection with gad-alum, including influenza vaccine
Descripción

Vaccines | Vaccines Planned | Influenza vaccine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C0021403
10. participation in other clinical trials with a new chemical entity within the previous 3 months
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
11. inability or unwillingness to comply with the provisions of this protocol
Descripción

Protocol Compliance Unable | Protocol Compliance Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
12. a history of alcohol or drug abuse
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
13. a significant illness other than diabetes within 2 weeks prior to first dosing
Descripción

Illness Significant | Exception Diabetes Mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011849
14. known human immunodeficiency virus (hiv)
Descripción

HIV Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
15. prior or active viral hepatitis b or c infection
Descripción

Hepatitis B | Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
16. females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine βhcg on-site within 24 hours prior to the gad-alum and etanercept administration, respectively)
Descripción

Breast Feeding | Pregnancy | Gender Menarche Urine pregnancy test Negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0025274
UMLS CUI [3,3]
C0430056
UMLS CUI [3,4]
C1513916
17. males or females not willing to use adequate contraception, if sexually active, until 1 year after the last gad-alum and etanercept administration, respectively
Descripción

Gender Sexually active | Contraceptive methods Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
18. presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigator makes the patient non-eligible for the study.
Descripción

Comorbidity Serious Excludes Subcutaneous Injection | Condition Serious Excludes Subcutaneous Injection | Skin Infection Excludes Subcutaneous Injection | Study Subject Participation Status Ineligible

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0021499
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C0021499
UMLS CUI [3,1]
C0037278
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0021499
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C1512714
19. deemed by the investigator not being able to follow instructions and/or follow the study protocol
Descripción

Protocol Compliance Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
20. active infection, including chronic and local infection or a history of previous tendency to serious infections, recent or ongoing uncontrolled bacterial, viral, fungal or other opportunistic infections, or known infection with active ebv or cmv
Descripción

Communicable Disease | Chronic infectious disease | Local infection | Predisposition Communicable Diseases Serious | Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Opportunistic Infections Uncontrolled | Epstein-Barr Virus Infections | Cytomegalovirus Infections

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
UMLS CUI [3]
C1400591
UMLS CUI [4,1]
C0220898
UMLS CUI [4,2]
C0009450
UMLS CUI [4,3]
C0205404
UMLS CUI [5,1]
C0004623
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0042769
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C0026946
UMLS CUI [7,2]
C0205318
UMLS CUI [8,1]
C0029118
UMLS CUI [8,2]
C0205318
UMLS CUI [9]
C0149678
UMLS CUI [10]
C0010823
21. hypersensivity to the active substance in enbrel (etanercept) or other ingredients in enbrel
Descripción

Hypersensitivity Enbrel Active ingredient | Hypersensitivity Etanercept | Hypersensitivity Enbrel Ingredient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0720193
UMLS CUI [1,3]
C1372955
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0717758
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0720193
UMLS CUI [3,3]
C1550600
22. active or inactive (latent) tuberculosis (tbc) at screening
Descripción

Tuberculosis | Latent Tuberculosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2]
C1609538
23. history of malignancy or significant cardiovascular disease
Descripción

Malignant Neoplasms | Cardiovascular Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007222
24. current or history of leukopenia, anemia and/or thrombocytopeni
Descripción

Leukopenia | Anemia | Thrombocytopenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023530
UMLS CUI [2]
C0002871
UMLS CUI [3]
C0040034
25. liver disease (clinical or hepatic enzymes >3 times the upper limit of normal (uln))
Descripción

Liver diseases | Elevated liver enzymes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0235996
26. renal insufficiency (clinical or creatinine >3 times the upper limit of normal (uln))
Descripción

Renal Insufficiency | Serum creatinine raised

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
27. ms, undefined neurologic condition or known sle, or anti-nuclear or known doublestranded dna antibody positivity
Descripción

Multiple Sclerosis | Condition Neurologic undefined | Lupus Erythematosus, Systemic | Anti-nuclear factor positive | Double stranded DNA antibody positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205494
UMLS CUI [2,3]
C0750600
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0151480
UMLS CUI [5]
C2747922
28. arrhythmia
Descripción

Cardiac Arrhythmia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003811
29. pancreatitis
Descripción

Pancreatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030305
30. vitamin d serum levels >100 nmol/l at screening
Descripción

Serum vitamin D measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428586
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT02464033

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Informed Consent Parent | Informed Consent Guardian
Item
1. informed consent given by patients and parent(s)/legal guardian(s)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Diabetes Mellitus, Insulin-Dependent
Item
2. type 1 diabetes according to the ada classification, diagnosed within the previous 100 days at the time of screening
boolean
C0011854 (UMLS CUI [1])
Age
Item
3. age 8.00 -17.99 years at time of screening
boolean
C0001779 (UMLS CUI [1])
Fasting C-peptide level
Item
4. fasting c-peptide at time of screening ≥0.12 nmol/l
boolean
C2208720 (UMLS CUI [1])
Anti-GAD antibody positive
Item
5. positive for gada but < 50 000 units
boolean
C1167896 (UMLS CUI [1])
Gender Menarche Avoidance Pregnancy | Gender Menarche Urine pregnancy test negative
Item
6. menarchal females must agree to avoid pregnancy and have a negative urine pregnancy test
boolean
C0079399 (UMLS CUI [1,1])
C0025274 (UMLS CUI [1,2])
C0870186 (UMLS CUI [1,3])
C0032961 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2,1])
C0025274 (UMLS CUI [2,2])
C0430057 (UMLS CUI [2,3])
Immunity Chickenpox | Communicable Disease Previous | Vaccination Previous
Item
7. immunity against varicella, either through previous infection or vaccination
boolean
C0020964 (UMLS CUI [1,1])
C0008049 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0042196 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Adherence Vaccination Program Swedish
Item
8. patients must follow the swedish vaccination programme
boolean
C1510802 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
C1710263 (UMLS CUI [1,4])
Childbearing Potential Sexually active Contraceptive methods
Item
9. patients of childbearing potential must agree to using adequate contraception, if sexually active, until 1 year after the last administration of gad-alum and etanercept. adequate contraception is as follows:
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Gender Childbearing Potential
Item
for females of childbearing potential:
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
Contraceptives, Oral, Hormonal | Exception Progestins Low dose | Exception Lynestrenol Low dose | Exception Norethindrone Low dose | Injectable contraception Hormonal | Contraceptive implant Hormonal
Item
1. oral (except low-dose gestagen (lynestrenol and norestisteron), injectable, or implanted hormonal contraceptives (females)
boolean
C0009907 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0033306 (UMLS CUI [2,2])
C0445550 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0024321 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0028356 (UMLS CUI [4,2])
C0445550 (UMLS CUI [4,3])
C1262153 (UMLS CUI [5,1])
C0458083 (UMLS CUI [5,2])
C1657106 (UMLS CUI [6,1])
C0458083 (UMLS CUI [6,2])
Intrauterine Devices
Item
2. intrauterine device (females)
boolean
C0021900 (UMLS CUI [1])
Intrauterine System | Contraceptive coil Progestin Releasing
Item
3. intrauterine system (for example, progestin-releasing coil) (females)
boolean
C4293370 (UMLS CUI [1])
C0419518 (UMLS CUI [2,1])
C0033306 (UMLS CUI [2,2])
C1283071 (UMLS CUI [2,3])
Vasectomy
Item
4. vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate)
boolean
C0042387 (UMLS CUI [1])
Gender Childbearing Potential
Item
for males of childbearing potential:
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
Condoms, Male
Item
a. condom (male)
boolean
C0009653 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Immunosuppressant drug therapy | Topical Steroid Therapy Accepted | Inhaled steroids Accepted
Item
1. previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
boolean
C1096650 (UMLS CUI [1])
C3897353 (UMLS CUI [2,1])
C1272684 (UMLS CUI [2,2])
C2065041 (UMLS CUI [3,1])
C1272684 (UMLS CUI [3,2])
Anti-Inflammatory Agents Continuous
Item
2. continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
boolean
C0003209 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Antidiabetics Oral | Antidiabetics Injection | Hypoglycemic Agents | Exception Insulin
Item
3. treatment with any oral or injected anti-diabetic medications (especially hypoglycemic agents) other than insulin
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C0020616 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0021641 (UMLS CUI [4,2])
Vitamin D | Vitamin D Discontinue Unwilling
Item
4. treatment with vitamin d, marketed or not, or unwilling to abstain from such medication during the trial
boolean
C0042866 (UMLS CUI [1])
C0042866 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Hypercalcemia
Item
5. a history of hypercalcemia
boolean
C0020437 (UMLS CUI [1])
Anemia | Abnormal Hematology Test Result
Item
6. a history of anaemia or significantly abnormal haematology results at screening
boolean
C0002871 (UMLS CUI [1])
C1332130 (UMLS CUI [2])
Epilepsy | Craniocerebral Trauma | Cerebrovascular accident | Feature Continuous motor unit activity Proximal Muscle
Item
7. a history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles
boolean
C0014544 (UMLS CUI [1])
C0018674 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C2348519 (UMLS CUI [4,1])
C0429352 (UMLS CUI [4,2])
C2984223 (UMLS CUI [4,3])
Acute allergic reaction Vaccines | Drug Allergy
Item
8. clinically significant history of acute reaction to vaccines or other drugs in the past
boolean
C0413234 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2])
Vaccines | Vaccines Planned | Influenza vaccine
Item
9. treatment with any vaccine within 4 months prior to planned first administration of gad-alum or planned treatment with vaccine up to 4 months after the last injection with gad-alum, including influenza vaccine
boolean
C0042210 (UMLS CUI [1])
C0042210 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0021403 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs
Item
10. participation in other clinical trials with a new chemical entity within the previous 3 months
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
11. inability or unwillingness to comply with the provisions of this protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Substance Use Disorders
Item
12. a history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Illness Significant | Exception Diabetes Mellitus
Item
13. a significant illness other than diabetes within 2 weeks prior to first dosing
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
HIV Infection
Item
14. known human immunodeficiency virus (hiv)
boolean
C0019693 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
15. prior or active viral hepatitis b or c infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Breast Feeding | Pregnancy | Gender Menarche Urine pregnancy test Negative
Item
16. females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine βhcg on-site within 24 hours prior to the gad-alum and etanercept administration, respectively)
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0025274 (UMLS CUI [3,2])
C0430056 (UMLS CUI [3,3])
C1513916 (UMLS CUI [3,4])
Gender Sexually active | Contraceptive methods Unwilling
Item
17. males or females not willing to use adequate contraception, if sexually active, until 1 year after the last gad-alum and etanercept administration, respectively
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Comorbidity Serious Excludes Subcutaneous Injection | Condition Serious Excludes Subcutaneous Injection | Skin Infection Excludes Subcutaneous Injection | Study Subject Participation Status Ineligible
Item
18. presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigator makes the patient non-eligible for the study.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0021499 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0021499 (UMLS CUI [2,4])
C0037278 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0021499 (UMLS CUI [3,3])
C2348568 (UMLS CUI [4,1])
C1512714 (UMLS CUI [4,2])
Protocol Compliance Unable
Item
19. deemed by the investigator not being able to follow instructions and/or follow the study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Communicable Disease | Chronic infectious disease | Local infection | Predisposition Communicable Diseases Serious | Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Opportunistic Infections Uncontrolled | Epstein-Barr Virus Infections | Cytomegalovirus Infections
Item
20. active infection, including chronic and local infection or a history of previous tendency to serious infections, recent or ongoing uncontrolled bacterial, viral, fungal or other opportunistic infections, or known infection with active ebv or cmv
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C1400591 (UMLS CUI [3])
C0220898 (UMLS CUI [4,1])
C0009450 (UMLS CUI [4,2])
C0205404 (UMLS CUI [4,3])
C0004623 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0042769 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0026946 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0029118 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C0149678 (UMLS CUI [9])
C0010823 (UMLS CUI [10])
Hypersensitivity Enbrel Active ingredient | Hypersensitivity Etanercept | Hypersensitivity Enbrel Ingredient
Item
21. hypersensivity to the active substance in enbrel (etanercept) or other ingredients in enbrel
boolean
C0020517 (UMLS CUI [1,1])
C0720193 (UMLS CUI [1,2])
C1372955 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0717758 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0720193 (UMLS CUI [3,2])
C1550600 (UMLS CUI [3,3])
Tuberculosis | Latent Tuberculosis
Item
22. active or inactive (latent) tuberculosis (tbc) at screening
boolean
C0041296 (UMLS CUI [1])
C1609538 (UMLS CUI [2])
Malignant Neoplasms | Cardiovascular Disease
Item
23. history of malignancy or significant cardiovascular disease
boolean
C0006826 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
Leukopenia | Anemia | Thrombocytopenia
Item
24. current or history of leukopenia, anemia and/or thrombocytopeni
boolean
C0023530 (UMLS CUI [1])
C0002871 (UMLS CUI [2])
C0040034 (UMLS CUI [3])
Liver diseases | Elevated liver enzymes
Item
25. liver disease (clinical or hepatic enzymes >3 times the upper limit of normal (uln))
boolean
C0023895 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
Renal Insufficiency | Serum creatinine raised
Item
26. renal insufficiency (clinical or creatinine >3 times the upper limit of normal (uln))
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Multiple Sclerosis | Condition Neurologic undefined | Lupus Erythematosus, Systemic | Anti-nuclear factor positive | Double stranded DNA antibody positive
Item
27. ms, undefined neurologic condition or known sle, or anti-nuclear or known doublestranded dna antibody positivity
boolean
C0026769 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0205494 (UMLS CUI [2,2])
C0750600 (UMLS CUI [2,3])
C0024141 (UMLS CUI [3])
C0151480 (UMLS CUI [4])
C2747922 (UMLS CUI [5])
Cardiac Arrhythmia
Item
28. arrhythmia
boolean
C0003811 (UMLS CUI [1])
Pancreatitis
Item
29. pancreatitis
boolean
C0030305 (UMLS CUI [1])
Serum vitamin D measurement
Item
30. vitamin d serum levels >100 nmol/l at screening
boolean
C0428586 (UMLS CUI [1])
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