ID

21790

Descrição

Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00594932

Link

https://clinicaltrials.gov/show/NCT00594932

Palavras-chave

Versões (1)
  1. 30/04/2017 30/04/2017 -
Transferido a

30 de abril de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Systemic Lupus Erythematosus NCT00594932

Inglês

Eligibility Systemic Lupus Erythematosus NCT00594932

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of sle by the 1995 modification of revised acr criteria (includes antiphospholipid antibodies)
Descrição

ACR Criteria for SLE

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4055473
2. bilag a arthritis or bilag b arthritis with at least 6 tender and 4 swollen joints at screening and baseline
Descrição

Bilag Arthritis and number of tender and swollen joints

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4055346
UMLS CUI [2]
C0451530
UMLS CUI [3]
C0451521
3. stable prednisone dose at 20 mg of less for one month at baseline.
Descrição

Stable Prednisone Dose

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0178602
4. if on antimalarials must be stable for at least one month at baseline
Descrição

Antimalarias

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003374
5. if on nsaids must be on a stable regimen for at least one month but can be prn dosing
Descrição

NSAID Use

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2911180
6. must be willing to withdraw from azathioprine or mtx at the time of screening.
Descrição

Withdraw from Azathioprine or MTX

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0004482
UMLS CUI [2,1]
C2349954
UMLS CUI [2,2]
C0025677
7. between ages 14 and 70
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
8. women of childbearing potential must have a negative pregnancy test at screening and at each month during the study.
Descrição

Pregnancy Test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032976
9. all participants (male and female) must, if fertile, agree to practice contraception during the entire course of the study. this may include barrier, oral contraceptives, depo-provera, intrauterine device and/or abstinence.
Descrição

Contraceptive Methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inability to understand informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
2. drug or alcohol abuse within the past six months
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
3. in the opinion of the investigator, it is not likely the patient can comply with the protocol for any reason, or participation in the protocol is not in the patient's best interest.
Descrição

Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
4. unstable medical condition that, in the opinion of the investigator would contraindicate study participation
Descrição

Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
5. history of malignancy (except for basal cell carcinoma at any time and/or cervical cancer or squamous cell cancer at least five years previous to screening).
Descrição

Prior Malignancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2735088
6. use of cyclosporine, leflunomide, cyclophosphamide or any biologic agent within three months prior to screening.
Descrição

Cyclosporine, leflunomide, cyclophosphamide or any biologic agent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2]
C0063041
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0005515
7. participation in any clinical study of an investigational agent within three months of screening -
Descrição

Study Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Systemic Lupus Erythematosus NCT00594932

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
ACR Criteria for SLE
Item
1. diagnosis of sle by the 1995 modification of revised acr criteria (includes antiphospholipid antibodies)
boolean
C4055473 (UMLS CUI [1])
Bilag Arthritis and number of tender and swollen joints
Item
2. bilag a arthritis or bilag b arthritis with at least 6 tender and 4 swollen joints at screening and baseline
boolean
C4055346 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
Stable Prednisone Dose
Item
3. stable prednisone dose at 20 mg of less for one month at baseline.
boolean
C0032952 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Antimalarias
Item
4. if on antimalarials must be stable for at least one month at baseline
boolean
C0003374 (UMLS CUI [1])
NSAID Use
Item
5. if on nsaids must be on a stable regimen for at least one month but can be prn dosing
boolean
C2911180 (UMLS CUI [1])
Withdraw from Azathioprine or MTX
Item
6. must be willing to withdraw from azathioprine or mtx at the time of screening.
boolean
C2349954 (UMLS CUI [1,1])
C0004482 (UMLS CUI [1,2])
C2349954 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
Age
Item
7. between ages 14 and 70
boolean
C0001779 (UMLS CUI [1])
Pregnancy Test
Item
8. women of childbearing potential must have a negative pregnancy test at screening and at each month during the study.
boolean
C0032976 (UMLS CUI [1])
Contraceptive Methods
Item
9. all participants (male and female) must, if fertile, agree to practice contraception during the entire course of the study. this may include barrier, oral contraceptives, depo-provera, intrauterine device and/or abstinence.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent
Item
1. inability to understand informed consent
boolean
C0021430 (UMLS CUI [1])
Substance Use Disorders
Item
2. drug or alcohol abuse within the past six months
boolean
C0038586 (UMLS CUI [1])
Compliance
Item
3. in the opinion of the investigator, it is not likely the patient can comply with the protocol for any reason, or participation in the protocol is not in the patient's best interest.
boolean
C1321605 (UMLS CUI [1])
Comorbidity
Item
4. unstable medical condition that, in the opinion of the investigator would contraindicate study participation
boolean
C0009488 (UMLS CUI [1])
Prior Malignancy
Item
5. history of malignancy (except for basal cell carcinoma at any time and/or cervical cancer or squamous cell cancer at least five years previous to screening).
boolean
C2735088 (UMLS CUI [1])
Cyclosporine, leflunomide, cyclophosphamide or any biologic agent
Item
6. use of cyclosporine, leflunomide, cyclophosphamide or any biologic agent within three months prior to screening.
boolean
C0010592 (UMLS CUI [1])
C0063041 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0005515 (UMLS CUI [4])
Study Participation Status
Item
7. participation in any clinical study of an investigational agent within three months of screening -
boolean
C2348568 (UMLS CUI [1])
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