ID

31949

Beschreibung

Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers; ODM derived from: https://clinicaltrials.gov/show/NCT01029613

Link

https://clinicaltrials.gov/show/NCT01029613

Stichworte

Versionen (1)
  1. 09.10.18 09.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01029613

Englisch

Eligibility Rheumatoid Arthritis NCT01029613

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 years old and < 85 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ra in accordance with american college of rheumatology 1987 criteria
Beschreibung

Rheumatoid Arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
moderate or highly active ra defined as das28 > 3,2 (crp based)
Beschreibung

Rheumatoid arthritis moderate Disease activity score das28 C-reactive protein measurement | Rheumatoid Arthritis Severe Disease activity score das28 C-reactive protein measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368567
UMLS CUI [1,2]
C4481729
UMLS CUI [1,3]
C0201657
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C4481729
UMLS CUI [2,4]
C0201657
clinical indication for tnf-α inhibitor treatment by the treating physician
Beschreibung

Indication TNF alpha inhibitor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C4521709
no contraindications for tnf-α inhibitor treatment
Beschreibung

Medical contraindication Absent TNF alpha inhibitor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C4521709
no contraindications for mri
Beschreibung

Medical contraindication Absent MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0024485
serum creatinine in normal range
Beschreibung

Serum creatinine normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0438244
sufficient contraception for fertile women
Beschreibung

Childbearing Potential Contraceptive methods Sufficient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0205410
capable of giving informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
capable of complying with the examination program of the protocol
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
other dmards than mtx from less than 4 weeks before inclusion and throughout the study period
Beschreibung

DMARDs | Exception Methotrexate

Datentyp

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025677
cyclophosphamide, chlorambucil or other alkylating agents from less than 4 weeks before inclusion and throughout the study period
Beschreibung

Cyclophosphamide | Chlorambucil | Alkylating Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0010583
UMLS CUI [2]
C0008163
UMLS CUI [3]
C0002073
intramuscular or intravenous injection of glucocorticoid from less than 4 weeks before inclusion and throughout the study period
Beschreibung

Glucocorticoids Intramuscular injection | Glucocorticoids Intravenous Injection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C0021492
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C0021494
pregnancy wish, pregnancy or breast-feeding
Beschreibung

Pregnancy, Planned | Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032992
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
contraindications for tnf-α inhibitor treatment
Beschreibung

Medical contraindication TNF alpha inhibitor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C4521709
contraindications for mri
Beschreibung

Medical contraindication MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
known recent drug or alcohol abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
failure to provide written consent
Beschreibung

Informed Consent failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
incapable of complying with the examination program for physical or mental reasons
Beschreibung

Protocol Compliance Unable | Etiology Physically Handicapped | Etiology Mental handicap

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0086807
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C1306341
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT01029613

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18 years old and < 85 years old
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis
Item
ra in accordance with american college of rheumatology 1987 criteria
boolean
C0003873 (UMLS CUI [1])
Rheumatoid arthritis moderate Disease activity score das28 C-reactive protein measurement | Rheumatoid Arthritis Severe Disease activity score das28 C-reactive protein measurement
Item
moderate or highly active ra defined as das28 > 3,2 (crp based)
boolean
C2368567 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
C0201657 (UMLS CUI [1,3])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4481729 (UMLS CUI [2,3])
C0201657 (UMLS CUI [2,4])
Indication TNF alpha inhibitor
Item
clinical indication for tnf-α inhibitor treatment by the treating physician
boolean
C3146298 (UMLS CUI [1,1])
C4521709 (UMLS CUI [1,2])
Medical contraindication Absent TNF alpha inhibitor
Item
no contraindications for tnf-α inhibitor treatment
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4521709 (UMLS CUI [1,3])
Medical contraindication Absent MRI
Item
no contraindications for mri
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Serum creatinine normal
Item
serum creatinine in normal range
boolean
C0438244 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Sufficient
Item
sufficient contraception for fertile women
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205410 (UMLS CUI [1,3])
Informed Consent
Item
capable of giving informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
capable of complying with the examination program of the protocol
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
DMARDs | Exception Methotrexate
Item
other dmards than mtx from less than 4 weeks before inclusion and throughout the study period
boolean
C0242708 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
Cyclophosphamide | Chlorambucil | Alkylating Agents
Item
cyclophosphamide, chlorambucil or other alkylating agents from less than 4 weeks before inclusion and throughout the study period
boolean
C0010583 (UMLS CUI [1])
C0008163 (UMLS CUI [2])
C0002073 (UMLS CUI [3])
Glucocorticoids Intramuscular injection | Glucocorticoids Intravenous Injection
Item
intramuscular or intravenous injection of glucocorticoid from less than 4 weeks before inclusion and throughout the study period
boolean
C0017710 (UMLS CUI [1,1])
C0021492 (UMLS CUI [1,2])
C0017710 (UMLS CUI [2,1])
C0021494 (UMLS CUI [2,2])
Pregnancy, Planned | Pregnancy | Breast Feeding
Item
pregnancy wish, pregnancy or breast-feeding
boolean
C0032992 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Medical contraindication TNF alpha inhibitor
Item
contraindications for tnf-α inhibitor treatment
boolean
C1301624 (UMLS CUI [1,1])
C4521709 (UMLS CUI [1,2])
Medical contraindication MRI
Item
contraindications for mri
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Substance Use Disorders
Item
known recent drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Informed Consent failed
Item
failure to provide written consent
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Protocol Compliance Unable | Etiology Physically Handicapped | Etiology Mental handicap
Item
incapable of complying with the examination program for physical or mental reasons
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0086807 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C1306341 (UMLS CUI [3,2])
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