ID

21790

Description

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

Lien

https://clinicaltrials.gov/show/NCT00594932

Mots-clés

Versions (1)
  1. 30/04/2017 30/04/2017 -
Téléchargé le

30 avril 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Systemic Lupus Erythematosus NCT00594932

Anglais

Eligibility Systemic Lupus Erythematosus NCT00594932

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

ACR Criteria for SLE

Type de données

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
Description

Bilag Arthritis and number of tender and swollen joints

Type de données

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.
Description

Stable Prednisone Dose

Type de données

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
Description

Antimalarias

Type de données

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
Description

NSAID Use

Type de données

boolean

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

Withdraw from Azathioprine or MTX

Type de données

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
Description

Age

Type de données

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.
Description

Pregnancy Test

Type de données

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.
Description

Contraceptive Methods

Type de données

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

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

Informed Consent

Type de données

boolean

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

Substance Use Disorders

Type de données

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.
Description

Compliance

Type de données

boolean

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

Comorbidity

Type de données

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).
Description

Prior Malignancy

Type de données

boolean

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

Cyclosporine, leflunomide, cyclophosphamide or any biologic agent

Type de données

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 -
Description

Study Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Systemic Lupus Erythematosus NCT00594932

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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