ID

39057

Description

Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01593332

Link

https://clinicaltrials.gov/show/NCT01593332

Keywords

  1. 11/26/19 11/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 26, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility DMARD Resistant Rheumatoid Arthritis NCT01593332

Eligibility DMARD Resistant Rheumatoid Arthritis NCT01593332

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1987 acr criteria for classification of ra
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
positive for rheumatoid factor(rf)
Description

Rheumatoid factor positive

Data type

boolean

Alias
UMLS CUI [1]
C0151379
active ra despite therapy with conventional for at least 3 months as evidenced by das 28 > 3/2
Description

Rheumatoid Arthritis DAS28 | Standard therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C2732493
UMLS CUI [2]
C2936643
patients with active, resistant ra who didn't receive anti tnf agents.
Description

Rheumatoid Arthritis Resistant | Anti-TNF therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0332325
UMLS CUI [2,1]
C0281481
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with hypogammaglobulinemia
Description

Hypogammaglobulinemia

Data type

boolean

Alias
UMLS CUI [1]
C0086438
patient with congestive heart failure (classiv)
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
active current bacterial,viral,fungal,myocardial or other infections
Description

Bacterial Infections | Virus Diseases | Mycoses | Myocardial viral infection | Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0042769
UMLS CUI [3]
C0026946
UMLS CUI [4]
C1400784
UMLS CUI [5]
C0009450
chronic hepatitis b or hepatitis c carriers
Description

HEPATITIS B CHRONIC CARRIER | Hepatitis C carrier chronic

Data type

boolean

Alias
UMLS CUI [1]
C0744832
UMLS CUI [2,1]
C0400920
UMLS CUI [2,2]
C0205191
history of severe allergic reaction to human,humanized or murine monoclonal antibodies
Description

Severe allergic reaction Human Monoclonal Antibodies | Severe allergic reaction Humanized Monoclonal Antibodies | Severe allergic reaction Murine-Derived Monoclonal Antibodies

Data type

boolean

Alias
UMLS CUI [1,1]
C2220378
UMLS CUI [1,2]
C0003250
UMLS CUI [1,3]
C0086418
UMLS CUI [2,1]
C2220378
UMLS CUI [2,2]
C2985546
UMLS CUI [3,1]
C2220378
UMLS CUI [3,2]
C2916903
history of malignancies
Description

History of malignant neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0455471
pregnant women or lactating mothers 8) patients with chronic renal failure and hepatic disease.
Description

Pregnancy | Breast Feeding | Kidney Failure, Chronic | Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0022661
UMLS CUI [4]
C0341439

Similar models

Eligibility DMARD Resistant Rheumatoid Arthritis NCT01593332

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
1987 acr criteria for classification of ra
boolean
C0003873 (UMLS CUI [1])
Rheumatoid factor positive
Item
positive for rheumatoid factor(rf)
boolean
C0151379 (UMLS CUI [1])
Rheumatoid Arthritis DAS28 | Standard therapy
Item
active ra despite therapy with conventional for at least 3 months as evidenced by das 28 > 3/2
boolean
C0003873 (UMLS CUI [1,1])
C2732493 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2])
Rheumatoid Arthritis Resistant | Anti-TNF therapy Absent
Item
patients with active, resistant ra who didn't receive anti tnf agents.
boolean
C0003873 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0281481 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypogammaglobulinemia
Item
patient with hypogammaglobulinemia
boolean
C0086438 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
patient with congestive heart failure (classiv)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Bacterial Infections | Virus Diseases | Mycoses | Myocardial viral infection | Communicable Diseases
Item
active current bacterial,viral,fungal,myocardial or other infections
boolean
C0004623 (UMLS CUI [1])
C0042769 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
C1400784 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
HEPATITIS B CHRONIC CARRIER | Hepatitis C carrier chronic
Item
chronic hepatitis b or hepatitis c carriers
boolean
C0744832 (UMLS CUI [1])
C0400920 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Severe allergic reaction Human Monoclonal Antibodies | Severe allergic reaction Humanized Monoclonal Antibodies | Severe allergic reaction Murine-Derived Monoclonal Antibodies
Item
history of severe allergic reaction to human,humanized or murine monoclonal antibodies
boolean
C2220378 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
C0086418 (UMLS CUI [1,3])
C2220378 (UMLS CUI [2,1])
C2985546 (UMLS CUI [2,2])
C2220378 (UMLS CUI [3,1])
C2916903 (UMLS CUI [3,2])
History of malignant neoplasm
Item
history of malignancies
boolean
C0455471 (UMLS CUI [1])
Pregnancy | Breast Feeding | Kidney Failure, Chronic | Chronic liver disease
Item
pregnant women or lactating mothers 8) patients with chronic renal failure and hepatic disease.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0022661 (UMLS CUI [3])
C0341439 (UMLS CUI [4])

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