ID

25272

Descrição

Rituximab in Rheumatoid Arthritis Lung Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00578565

Link

https://clinicaltrials.gov/show/NCT00578565

Palavras-chave

Versões (1)
  1. 29/08/2017 29/08/2017 -
Transferido a

29 de agosto de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00578565

Inglês

Eligibility Rheumatoid Arthritis NCT00578565

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of ra according to the revised 1987 american rheumatism association criteria
Descrição

Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003873
2. absence of clinical features suggesting infection, neoplasm, sarcoidosis, interstitial lung disease other than uip or nsip, other collagen vascular disease, or exposure to known fibrogenic drugs or environmental factors
Descrição

Absence Feature Suggestive of Communicable Disease | Absence Feature Suggestive of Neoplasms | Absence Feature Suggestive of Sarcoidosis | Absence Feature Suggestive of Interstitial Lung Disease | Exception Idiopathic Pulmonary Fibrosis | Exception Nonspecific interstitial pneumonia | Collagen-vascular disease | Exposure to Fibrogenesis Pharmaceutical Preparations | Exposure to Exogenous Factors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C2348519
UMLS CUI [1,3]
C0332299
UMLS CUI [1,4]
C0009450
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C2348519
UMLS CUI [2,3]
C0332299
UMLS CUI [2,4]
C0027651
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C2348519
UMLS CUI [3,3]
C0332299
UMLS CUI [3,4]
C0036202
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C2348519
UMLS CUI [4,3]
C0332299
UMLS CUI [4,4]
C0206062
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1800706
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1290344
UMLS CUI [7]
C0262428
UMLS CUI [8,1]
C0332157
UMLS CUI [8,2]
C0596570
UMLS CUI [8,3]
C0013227
UMLS CUI [9,1]
C0332157
UMLS CUI [9,2]
C1516998
3. diagnosis of progressive interstitial pneumonia of uip or nsip subtype, based on the following criteria
Descrição

Progressive Interstitial Pneumonia | Idiopathic Pulmonary Fibrosis Subtype | Nonspecific interstitial pneumonia Subtype

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0206061
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C1800706
UMLS CUI [2,2]
C0449560
UMLS CUI [3,1]
C1290344
UMLS CUI [3,2]
C0449560
1. clinical symptoms consistent with interstitial lung disease with onset between 3 months and 36 months prior to screening.
Descrição

Symptoms Consistent with Interstitial Lung Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0206062
2. worsening as demonstrated by any one of the following within the past year:
Descrição

Worsening

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0332271
> 10% decrease in forced vital capacity (fvc)
Descrição

Forced vital capacity decreased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1846678
increasing infiltrates on chest x-ray or high resolution computed tomography (hrct), or worsening dyspnea at rest or on exertion
Descrição

Infiltration Increasing Chest X-ray | Infiltration Increasing High Resolution Computed Tomography | Resting Dyspnea Worsening | Dyspnea on exertion Worsening

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332448
UMLS CUI [1,2]
C0442808
UMLS CUI [1,3]
C0039985
UMLS CUI [2,1]
C0332448
UMLS CUI [2,2]
C0442808
UMLS CUI [2,3]
C1512457
UMLS CUI [3,1]
C0743330
UMLS CUI [3,2]
C0332271
UMLS CUI [4,1]
C0231807
UMLS CUI [4,2]
C0332271
3. diagnosis of uip or nsip by either of the following:
Descrição

Idiopathic Pulmonary Fibrosis | Nonspecific interstitial pneumonia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1800706
UMLS CUI [2]
C1290344
open or video-assisted thoracic surgery (vats) lung biopsy showing definite or probable uip or nsip
Descrição

Idiopathic Pulmonary Fibrosis Open biopsy of lung | Idiopathic Pulmonary Fibrosis Video-assisted thoracoscopic lung biopsy | Nonspecific interstitial pneumonia Open biopsy of lung | Nonspecific interstitial pneumonia Video-assisted thoracoscopic lung biopsy | Idiopathic Pulmonary Fibrosis Probable Open biopsy of lung | Idiopathic Pulmonary Fibrosis Probable Video-assisted thoracoscopic lung biopsy | Nonspecific interstitial pneumonia Probable Open biopsy of lung | Nonspecific interstitial pneumonia Probable Video-assisted thoracoscopic lung biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1800706
UMLS CUI [1,2]
C0176514
UMLS CUI [2,1]
C1800706
UMLS CUI [2,2]
C0860958
UMLS CUI [3,1]
C1290344
UMLS CUI [3,2]
C0176514
UMLS CUI [4,1]
C1290344
UMLS CUI [4,2]
C0860958
UMLS CUI [5,1]
C1800706
UMLS CUI [5,2]
C0332148
UMLS CUI [5,3]
C0176514
UMLS CUI [6,1]
C1800706
UMLS CUI [6,2]
C0332148
UMLS CUI [6,3]
C0860958
UMLS CUI [7,1]
C1290344
UMLS CUI [7,2]
C0332148
UMLS CUI [7,3]
C0176514
UMLS CUI [8,1]
C1290344
UMLS CUI [8,2]
C0332148
UMLS CUI [8,3]
C0860958
hrct scan showing definite or probable uip or nsip and abnormal pulmonary function tests (reduced fvc or decreased diffusing capacity of carbon monoxide (dlco) or impaired gas exchange at rest or with exercise) and insidious onset of otherwise unexplained dyspnea or exertion and bibasilar, inspiratory crackles on auscultation
Descrição

Idiopathic Pulmonary Fibrosis High Resolution Computed Tomography | Nonspecific interstitial pneumonia High Resolution Computed Tomography | Idiopathic Pulmonary Fibrosis Probable High Resolution Computed Tomography | Nonspecific interstitial pneumonia Probable High Resolution Computed Tomography | Lung function testing abnormal | Forced vital capacity decreased | Decreased DLCO | Impaired gas exchange At rest | Impaired gas exchange Exercise | Dyspnea Explanation Lacking | Exertion Inspiratory crackles Auscultation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1800706
UMLS CUI [1,2]
C1512457
UMLS CUI [2,1]
C1290344
UMLS CUI [2,2]
C1512457
UMLS CUI [3,1]
C1800706
UMLS CUI [3,2]
C0332148
UMLS CUI [3,3]
C1512457
UMLS CUI [4,1]
C1290344
UMLS CUI [4,2]
C0332148
UMLS CUI [4,3]
C1512457
UMLS CUI [5]
C0476405
UMLS CUI [6]
C1846678
UMLS CUI [7]
C4073175
UMLS CUI [8,1]
C0150034
UMLS CUI [8,2]
C0443144
UMLS CUI [9,1]
C0150034
UMLS CUI [9,2]
C0015259
UMLS CUI [10,1]
C0013404
UMLS CUI [10,2]
C0681841
UMLS CUI [10,3]
C0332268
UMLS CUI [11,1]
C0015264
UMLS CUI [11,2]
C0577961
UMLS CUI [11,3]
C0004339
4. fvc > 50% of predicted value at screening
Descrição

Forced vital capacity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1287681
5. dlco >30% of predicted value at screening
Descrição

Carbon Monoxide Diffusing Capability Test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1516251
5. no change of disease-modifying anti-rheumatic drug (dmard) treatment within the last 3 months
Descrição

Disease-Modifying Antirheumatic Drugs unchanged

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0442739
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of clinically significant environmental or drug exposure known to cause pulmonary fibrosis.
Descrição

Environmental Exposure Causing Pulmonary Fibrosis | Drug exposure Causing Pulmonary Fibrosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0014412
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0034069
UMLS CUI [2,1]
C0743284
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0034069
2. forced expiratory volume in one second (fev1) fev1/fvc ratio < 0.6 at screening (pre-
Descrição

FEV1/FVC ratio pre bronchodilator

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0429745
UMLS CUI [1,2]
C2599602
or post-bronchodilator).
Descrição

FEV1/FVC ratio post bronchodilator

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0429745
UMLS CUI [1,2]
C2599594
3. residual volume > 120% predicted at screening
Descrição

Lung residual volume measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0429713
4. evidence of active infection
Descrição

Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
5. any pulmonary condition other than uip/nsip, which, in the opinion of the site principal investigator, is likely to result in the death of the patient within the next year
Descrição

Condition Pulmonary Life Expectancy Shortened | Exception Idiopathic Pulmonary Fibrosis | Exception Nonspecific interstitial pneumonia

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2709248
UMLS CUI [1,3]
C0023671
UMLS CUI [1,4]
C1282927
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1800706
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1290344
6. history of unstable or deteriorating cardiac or neurologic disease
Descrição

Heart Disease Unstable | Heart Disease Worsening | Nervous system disorder Unstable | Nervous system disorder Worsening

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0332271
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0332271
7. pregnancy or lactation
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. treatment with cyclophosphamide, cyclosporine, interferon gamma or beta, anti-tumor necrosis factor therapy, anti-interleukin 1 (il1) therapy or with endothelin receptor blockers within the last 8 weeks; experimental therapy for rheumatoid arthritis
Descrição

Cyclophosphamide | Cyclosporine | Interferon gamma | Interferon-beta | anti-tumor necrosis factor therapy | Interleukin-1 Receptor Antagonist | Endothelin Receptor Antagonists | Investigational Therapy Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0010583
UMLS CUI [2]
C0010592
UMLS CUI [3]
C2757040
UMLS CUI [4]
C0015980
UMLS CUI [5]
C0281481
UMLS CUI [6]
C3536785
UMLS CUI [7]
C2266875
UMLS CUI [8,1]
C0949266
UMLS CUI [8,2]
C0003873
9. creatinine > 1.5 x upper limit of normal range (uln) at screening
Descrição

Serum creatinine raised

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700225
10. hematology outside of specified limits: white blood cell (wbc) < 2,500/mm^3 or absolute neutrophil count (anc) < 1500
Descrição

Hematology finding abnormal | White Blood Cell Count procedure | Absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0475182
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
11. hematocrit < 27% or > 59%, platelets < 100,000/mm^3 at screening
Descrição

Hematocrit level | Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518014
UMLS CUI [2]
C0032181
12. positive hepatitis b or c serology
Descrição

HEPATITIS B SEROLOGY POSITIVE | Hepatitis C Serology positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0744838
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0242089
13. any medical condition, which in the opinion of the site principal investigator, may be adversely affected by the participation in this study
Descrição

Medical condition Adverse effects Due to Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0001688
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C2348568
14. history of recurrent significant infection or history of recurrent bacterial infections
Descrição

Recurrent infections | Recurrent bacterial infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0239998
UMLS CUI [2]
C1844383
15. known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
Descrição

Bacterial Infections | Virus Diseases | Mycoses | Mycobacterium Infections | Communicable Diseases | Tuberculosis | Mycobacterium Infections, Nontuberculous | Exception Nail bed infection fungal | Communicable Disease Episode Major Hospitalization Required | Communicable Disease Episode Requirement Intravenous antibiotic therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0042769
UMLS CUI [3]
C0026946
UMLS CUI [4]
C0026918
UMLS CUI [5]
C0009450
UMLS CUI [6]
C0041296
UMLS CUI [7]
C0026919
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C2242531
UMLS CUI [9,1]
C0009450
UMLS CUI [9,2]
C0332189
UMLS CUI [9,3]
C0205164
UMLS CUI [9,4]
C1708385
UMLS CUI [10,1]
C0009450
UMLS CUI [10,2]
C0332189
UMLS CUI [10,3]
C1514873
UMLS CUI [10,4]
C0559680
16. abnormal neurological examination reflective of central nervous disease, including paresis, cognitive impairment and problems with coordination
Descrição

Neurological examination abnormal | CNS disorder | Paresis | Impaired cognition | Abnormal coordination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1112537
UMLS CUI [2]
C0007682
UMLS CUI [3]
C0030552
UMLS CUI [4]
C0338656
UMLS CUI [5]
C0520966
17. current enrollment in another clinical trial
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
18. fever (>99.5º f)
Descrição

Fever

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0015967
19. history of previous rituximab administration
Descrição

rituximab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0393022
20. receipt of any vaccine, particularly live viral vaccines, within 4 weeks of first study dose
Descrição

Vaccines | Attenuated Live Virus Vaccine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2]
C1516086
21. decreased immunoglobulin g (igg) and immunoglobulin m (igm) levels (below lower limit of normal range)
Descrição

Decreased immunoglobulin G (IgG) | IgM deficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1859344
UMLS CUI [2]
C0239989
22. present or past malignancy
Descrição

Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
23. history of severe allergic or anaphylactic reaction to administration of humanized or murine monoclonal antibodies
Descrição

Severe allergy Humanized Monoclonal Antibodies | Severe allergy Monoclonal Antibodies Murine | Anaphylaxis severe Humanized Monoclonal Antibodies | Anaphylaxis severe Monoclonal Antibodies Murine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C2985546
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0003250
UMLS CUI [2,3]
C0026809
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C2985546
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0003250
UMLS CUI [4,4]
C0026809
24. positive human immunodeficiency virus (hiv) serology
Descrição

HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Rheumatoid Arthritis NCT00578565

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
1. diagnosis of ra according to the revised 1987 american rheumatism association criteria
boolean
C0003873 (UMLS CUI [1])
Absence Feature Suggestive of Communicable Disease | Absence Feature Suggestive of Neoplasms | Absence Feature Suggestive of Sarcoidosis | Absence Feature Suggestive of Interstitial Lung Disease | Exception Idiopathic Pulmonary Fibrosis | Exception Nonspecific interstitial pneumonia | Collagen-vascular disease | Exposure to Fibrogenesis Pharmaceutical Preparations | Exposure to Exogenous Factors
Item
2. absence of clinical features suggesting infection, neoplasm, sarcoidosis, interstitial lung disease other than uip or nsip, other collagen vascular disease, or exposure to known fibrogenic drugs or environmental factors
boolean
C0332197 (UMLS CUI [1,1])
C2348519 (UMLS CUI [1,2])
C0332299 (UMLS CUI [1,3])
C0009450 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C2348519 (UMLS CUI [2,2])
C0332299 (UMLS CUI [2,3])
C0027651 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C2348519 (UMLS CUI [3,2])
C0332299 (UMLS CUI [3,3])
C0036202 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C2348519 (UMLS CUI [4,2])
C0332299 (UMLS CUI [4,3])
C0206062 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C1800706 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1290344 (UMLS CUI [6,2])
C0262428 (UMLS CUI [7])
C0332157 (UMLS CUI [8,1])
C0596570 (UMLS CUI [8,2])
C0013227 (UMLS CUI [8,3])
C0332157 (UMLS CUI [9,1])
C1516998 (UMLS CUI [9,2])
Progressive Interstitial Pneumonia | Idiopathic Pulmonary Fibrosis Subtype | Nonspecific interstitial pneumonia Subtype
Item
3. diagnosis of progressive interstitial pneumonia of uip or nsip subtype, based on the following criteria
boolean
C0206061 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C1800706 (UMLS CUI [2,1])
C0449560 (UMLS CUI [2,2])
C1290344 (UMLS CUI [3,1])
C0449560 (UMLS CUI [3,2])
Symptoms Consistent with Interstitial Lung Disease
Item
1. clinical symptoms consistent with interstitial lung disease with onset between 3 months and 36 months prior to screening.
boolean
C1457887 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0206062 (UMLS CUI [1,3])
Worsening
Item
2. worsening as demonstrated by any one of the following within the past year:
boolean
C0332271 (UMLS CUI [1])
Forced vital capacity decreased
Item
> 10% decrease in forced vital capacity (fvc)
boolean
C1846678 (UMLS CUI [1])
Infiltration Increasing Chest X-ray | Infiltration Increasing High Resolution Computed Tomography | Resting Dyspnea Worsening | Dyspnea on exertion Worsening
Item
increasing infiltrates on chest x-ray or high resolution computed tomography (hrct), or worsening dyspnea at rest or on exertion
boolean
C0332448 (UMLS CUI [1,1])
C0442808 (UMLS CUI [1,2])
C0039985 (UMLS CUI [1,3])
C0332448 (UMLS CUI [2,1])
C0442808 (UMLS CUI [2,2])
C1512457 (UMLS CUI [2,3])
C0743330 (UMLS CUI [3,1])
C0332271 (UMLS CUI [3,2])
C0231807 (UMLS CUI [4,1])
C0332271 (UMLS CUI [4,2])
Idiopathic Pulmonary Fibrosis | Nonspecific interstitial pneumonia
Item
3. diagnosis of uip or nsip by either of the following:
boolean
C1800706 (UMLS CUI [1])
C1290344 (UMLS CUI [2])
Idiopathic Pulmonary Fibrosis Open biopsy of lung | Idiopathic Pulmonary Fibrosis Video-assisted thoracoscopic lung biopsy | Nonspecific interstitial pneumonia Open biopsy of lung | Nonspecific interstitial pneumonia Video-assisted thoracoscopic lung biopsy | Idiopathic Pulmonary Fibrosis Probable Open biopsy of lung | Idiopathic Pulmonary Fibrosis Probable Video-assisted thoracoscopic lung biopsy | Nonspecific interstitial pneumonia Probable Open biopsy of lung | Nonspecific interstitial pneumonia Probable Video-assisted thoracoscopic lung biopsy
Item
open or video-assisted thoracic surgery (vats) lung biopsy showing definite or probable uip or nsip
boolean
C1800706 (UMLS CUI [1,1])
C0176514 (UMLS CUI [1,2])
C1800706 (UMLS CUI [2,1])
C0860958 (UMLS CUI [2,2])
C1290344 (UMLS CUI [3,1])
C0176514 (UMLS CUI [3,2])
C1290344 (UMLS CUI [4,1])
C0860958 (UMLS CUI [4,2])
C1800706 (UMLS CUI [5,1])
C0332148 (UMLS CUI [5,2])
C0176514 (UMLS CUI [5,3])
C1800706 (UMLS CUI [6,1])
C0332148 (UMLS CUI [6,2])
C0860958 (UMLS CUI [6,3])
C1290344 (UMLS CUI [7,1])
C0332148 (UMLS CUI [7,2])
C0176514 (UMLS CUI [7,3])
C1290344 (UMLS CUI [8,1])
C0332148 (UMLS CUI [8,2])
C0860958 (UMLS CUI [8,3])
Idiopathic Pulmonary Fibrosis High Resolution Computed Tomography | Nonspecific interstitial pneumonia High Resolution Computed Tomography | Idiopathic Pulmonary Fibrosis Probable High Resolution Computed Tomography | Nonspecific interstitial pneumonia Probable High Resolution Computed Tomography | Lung function testing abnormal | Forced vital capacity decreased | Decreased DLCO | Impaired gas exchange At rest | Impaired gas exchange Exercise | Dyspnea Explanation Lacking | Exertion Inspiratory crackles Auscultation
Item
hrct scan showing definite or probable uip or nsip and abnormal pulmonary function tests (reduced fvc or decreased diffusing capacity of carbon monoxide (dlco) or impaired gas exchange at rest or with exercise) and insidious onset of otherwise unexplained dyspnea or exertion and bibasilar, inspiratory crackles on auscultation
boolean
C1800706 (UMLS CUI [1,1])
C1512457 (UMLS CUI [1,2])
C1290344 (UMLS CUI [2,1])
C1512457 (UMLS CUI [2,2])
C1800706 (UMLS CUI [3,1])
C0332148 (UMLS CUI [3,2])
C1512457 (UMLS CUI [3,3])
C1290344 (UMLS CUI [4,1])
C0332148 (UMLS CUI [4,2])
C1512457 (UMLS CUI [4,3])
C0476405 (UMLS CUI [5])
C1846678 (UMLS CUI [6])
C4073175 (UMLS CUI [7])
C0150034 (UMLS CUI [8,1])
C0443144 (UMLS CUI [8,2])
C0150034 (UMLS CUI [9,1])
C0015259 (UMLS CUI [9,2])
C0013404 (UMLS CUI [10,1])
C0681841 (UMLS CUI [10,2])
C0332268 (UMLS CUI [10,3])
C0015264 (UMLS CUI [11,1])
C0577961 (UMLS CUI [11,2])
C0004339 (UMLS CUI [11,3])
Forced vital capacity
Item
4. fvc > 50% of predicted value at screening
boolean
C1287681 (UMLS CUI [1])
Carbon Monoxide Diffusing Capability Test
Item
5. dlco >30% of predicted value at screening
boolean
C1516251 (UMLS CUI [1])
Disease-Modifying Antirheumatic Drugs unchanged
Item
5. no change of disease-modifying anti-rheumatic drug (dmard) treatment within the last 3 months
boolean
C0242708 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Environmental Exposure Causing Pulmonary Fibrosis | Drug exposure Causing Pulmonary Fibrosis
Item
1. history of clinically significant environmental or drug exposure known to cause pulmonary fibrosis.
boolean
C0014412 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0034069 (UMLS CUI [1,3])
C0743284 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0034069 (UMLS CUI [2,3])
FEV1/FVC ratio pre bronchodilator
Item
2. forced expiratory volume in one second (fev1) fev1/fvc ratio < 0.6 at screening (pre-
boolean
C0429745 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
FEV1/FVC ratio post bronchodilator
Item
or post-bronchodilator).
boolean
C0429745 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
Lung residual volume measurement
Item
3. residual volume > 120% predicted at screening
boolean
C0429713 (UMLS CUI [1])
Communicable Disease
Item
4. evidence of active infection
boolean
C0009450 (UMLS CUI [1])
Condition Pulmonary Life Expectancy Shortened | Exception Idiopathic Pulmonary Fibrosis | Exception Nonspecific interstitial pneumonia
Item
5. any pulmonary condition other than uip/nsip, which, in the opinion of the site principal investigator, is likely to result in the death of the patient within the next year
boolean
C0348080 (UMLS CUI [1,1])
C2709248 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C1282927 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C1800706 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1290344 (UMLS CUI [3,2])
Heart Disease Unstable | Heart Disease Worsening | Nervous system disorder Unstable | Nervous system disorder Worsening
Item
6. history of unstable or deteriorating cardiac or neurologic disease
boolean
C0018799 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0332271 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4,1])
C0332271 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
7. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cyclophosphamide | Cyclosporine | Interferon gamma | Interferon-beta | anti-tumor necrosis factor therapy | Interleukin-1 Receptor Antagonist | Endothelin Receptor Antagonists | Investigational Therapy Rheumatoid Arthritis
Item
8. treatment with cyclophosphamide, cyclosporine, interferon gamma or beta, anti-tumor necrosis factor therapy, anti-interleukin 1 (il1) therapy or with endothelin receptor blockers within the last 8 weeks; experimental therapy for rheumatoid arthritis
boolean
C0010583 (UMLS CUI [1])
C0010592 (UMLS CUI [2])
C2757040 (UMLS CUI [3])
C0015980 (UMLS CUI [4])
C0281481 (UMLS CUI [5])
C3536785 (UMLS CUI [6])
C2266875 (UMLS CUI [7])
C0949266 (UMLS CUI [8,1])
C0003873 (UMLS CUI [8,2])
Serum creatinine raised
Item
9. creatinine > 1.5 x upper limit of normal range (uln) at screening
boolean
C0700225 (UMLS CUI [1])
Hematology finding abnormal | White Blood Cell Count procedure | Absolute neutrophil count
Item
10. hematology outside of specified limits: white blood cell (wbc) < 2,500/mm^3 or absolute neutrophil count (anc) < 1500
boolean
C0475182 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
Hematocrit level | Platelet Count measurement
Item
11. hematocrit < 27% or > 59%, platelets < 100,000/mm^3 at screening
boolean
C0518014 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
HEPATITIS B SEROLOGY POSITIVE | Hepatitis C Serology positive
Item
12. positive hepatitis b or c serology
boolean
C0744838 (UMLS CUI [1])
C0019196 (UMLS CUI [2,1])
C0242089 (UMLS CUI [2,2])
Medical condition Adverse effects Due to Study Subject Participation Status
Item
13. any medical condition, which in the opinion of the site principal investigator, may be adversely affected by the participation in this study
boolean
C3843040 (UMLS CUI [1,1])
C0001688 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Recurrent infections | Recurrent bacterial infection
Item
14. history of recurrent significant infection or history of recurrent bacterial infections
boolean
C0239998 (UMLS CUI [1])
C1844383 (UMLS CUI [2])
Bacterial Infections | Virus Diseases | Mycoses | Mycobacterium Infections | Communicable Diseases | Tuberculosis | Mycobacterium Infections, Nontuberculous | Exception Nail bed infection fungal | Communicable Disease Episode Major Hospitalization Required | Communicable Disease Episode Requirement Intravenous antibiotic therapy
Item
15. known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
boolean
C0004623 (UMLS CUI [1])
C0042769 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
C0026918 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
C0041296 (UMLS CUI [6])
C0026919 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C2242531 (UMLS CUI [8,2])
C0009450 (UMLS CUI [9,1])
C0332189 (UMLS CUI [9,2])
C0205164 (UMLS CUI [9,3])
C1708385 (UMLS CUI [9,4])
C0009450 (UMLS CUI [10,1])
C0332189 (UMLS CUI [10,2])
C1514873 (UMLS CUI [10,3])
C0559680 (UMLS CUI [10,4])
Neurological examination abnormal | CNS disorder | Paresis | Impaired cognition | Abnormal coordination
Item
16. abnormal neurological examination reflective of central nervous disease, including paresis, cognitive impairment and problems with coordination
boolean
C1112537 (UMLS CUI [1])
C0007682 (UMLS CUI [2])
C0030552 (UMLS CUI [3])
C0338656 (UMLS CUI [4])
C0520966 (UMLS CUI [5])
Study Subject Participation Status
Item
17. current enrollment in another clinical trial
boolean
C2348568 (UMLS CUI [1])
Fever
Item
18. fever (>99.5º f)
boolean
C0015967 (UMLS CUI [1])
rituximab
Item
19. history of previous rituximab administration
boolean
C0393022 (UMLS CUI [1])
Vaccines | Attenuated Live Virus Vaccine
Item
20. receipt of any vaccine, particularly live viral vaccines, within 4 weeks of first study dose
boolean
C0042210 (UMLS CUI [1])
C1516086 (UMLS CUI [2])
Decreased immunoglobulin G (IgG) | IgM deficiency
Item
21. decreased immunoglobulin g (igg) and immunoglobulin m (igm) levels (below lower limit of normal range)
boolean
C1859344 (UMLS CUI [1])
C0239989 (UMLS CUI [2])
Malignant Neoplasms
Item
22. present or past malignancy
boolean
C0006826 (UMLS CUI [1])
Severe allergy Humanized Monoclonal Antibodies | Severe allergy Monoclonal Antibodies Murine | Anaphylaxis severe Humanized Monoclonal Antibodies | Anaphylaxis severe Monoclonal Antibodies Murine
Item
23. history of severe allergic or anaphylactic reaction to administration of humanized or murine monoclonal antibodies
boolean
C2945656 (UMLS CUI [1,1])
C2985546 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0003250 (UMLS CUI [2,2])
C0026809 (UMLS CUI [2,3])
C0002792 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2985546 (UMLS CUI [3,3])
C0002792 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0003250 (UMLS CUI [4,3])
C0026809 (UMLS CUI [4,4])
HIV Seropositivity
Item
24. positive human immunodeficiency virus (hiv) serology
boolean
C0019699 (UMLS CUI [1])
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