ID

37092

Descrição

Sarilumab Effect on the Pharmacokinetics of Simvastatin; ODM derived from: https://clinicaltrials.gov/show/NCT02017639

Link

https://clinicaltrials.gov/show/NCT02017639

Palavras-chave

Versões (1)
  1. 03/07/2019 03/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02017639

Inglês

Eligibility Rheumatoid Arthritis NCT02017639

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, between 18 and 75 years of age, inclusive. body weight between 50.0 and 120.0 kg, inclusive, if male, and between 40.0 and 110.0 kg, inclusive, if female.
Descrição

Age | Body Weight | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
UMLS CUI [3]
C0079399
diagnosis of ra, according to the acr/european league against rheumatism (eular) 2010 rheumatoid arthritis classification criteria with ≥ 3 months disease duration, acr class i-iii functional status, based on 1991 revised criteria (appendix b, 5). moderate-to-severely active ra, defined as:
Descrição

Rheumatoid Arthritis Disease length | Rheumatoid Arthritis Functional Status Class | Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0598463
UMLS CUI [2,3]
C0456387
UMLS CUI [3]
C2368567
UMLS CUI [4,1]
C0003873
UMLS CUI [4,2]
C0205082
o high sensitivity c-reactive protein (hs-crp) ≥ 6 mg/l
Descrição

Measurement of C-reactive protein using high sensitivity technique

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4040318
laboratory parameters within the normal range (or defined screening threshold for the investigator site), unless the investigator considers an abnormality to be clinically irrelevant for ra patients; however following lab values must be met:
Descrição

Laboratory Results Normal Range

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0086715
hemoglobin >8.5 g/dl
Descrição

Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
white blood cells >3000/mm3
Descrição

White Blood Cell Count procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023508
neutrophils >2000/mm3
Descrição

Neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0200633
platelet count >150 000 cells/mm3
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior or current significant concomitant illness(es) that, according to investigator's judgment, would adversely affect the patient's participation in the study.
Descrição

Comorbidity Adverse effects Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0879626
UMLS CUI [1,3]
C2348568
women of childbearing potential not protected by highly-effective contraceptive method(s) of birth control (as defined in the informed consent form), and/or who are unwilling or unable to be tested for pregnancy.
Descrição

Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Unwilling | Childbearing Potential Pregnancy Tests Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032976
UMLS CUI [3,3]
C1299582
participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening, whichever is longer.
Descrição

Study Subject Participation Status | Investigational New Drugs | Therapy, Investigational

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0949266
patients with active tb or a history of incompletely treated tb. history of chronic infection or active infection. history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than ra.
Descrição

Tuberculosis | Therapeutic procedure Incomplete Tuberculosis | Chronic infectious disease | Communicable Disease | Arthropathy Autoimmune | Inflammatory joint disease Systemic | Arthropathy Localized | Exception Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205257
UMLS CUI [2,3]
C0041296
UMLS CUI [3]
C0151317
UMLS CUI [4]
C0009450
UMLS CUI [5,1]
C0022408
UMLS CUI [5,2]
C0004364
UMLS CUI [6,1]
C0683381
UMLS CUI [6,2]
C0205373
UMLS CUI [7,1]
C0022408
UMLS CUI [7,2]
C0392752
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0003873
a systemic hypersensitivity reaction, other than localized injection site reaction, to any biologic drug.
Descrição

Systemic allergic reaction Biological agents | Exception Allergic Reaction Injection site Localized

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1736167
UMLS CUI [1,2]
C0005515
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1527304
UMLS CUI [2,3]
C2700396
UMLS CUI [2,4]
C0392752
history or presence of drug or alcohol abuse. prior or current interstitial lung disease diagnosed by high resolution computed tomography and/or lung biopsy with consistent findings on pulmonary function tests and corroborating clinical findings.
Descrição

Substance Use Disorders | Interstitial Lung Disease High Resolution Computed Tomography | Interstitial Lung Disease Biopsy of lung | With consistency Pulmonary function tests | With consistency Clinical findings

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0206062
UMLS CUI [2,2]
C1512457
UMLS CUI [3,1]
C0206062
UMLS CUI [3,2]
C0189485
UMLS CUI [4,1]
C0522508
UMLS CUI [4,2]
C0024119
UMLS CUI [5,1]
C0522508
UMLS CUI [5,2]
C0037088
prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the screening visit.
Descrição

Malignant Neoplasms | Lymphoproliferative Disorders | Exception Carcinoma in situ of uterine cervix Treated | Exception Squamous cell carcinoma of skin nonmetastatic treated | Exception Basal cell carcinoma nonmetastatic treated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0024314
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1518409
UMLS CUI [4,4]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007117
UMLS CUI [5,3]
C1518409
UMLS CUI [5,4]
C1522326
uncontrolled diabetes mellitus, defined as glycosylated hemoglobin (hba1c) ≥9% at the screening visit.
Descrição

DIABETES MELLITUS NOS UNCONTROLLED | Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0743131
UMLS CUI [2]
C0474680
current treatment with anti-tnf agents or other biologics. current treatment with ra-directed biologic agents with non- tnf-α antagonist. any contra-indications to simvastatin, according to the applicable labeling. current treatment with a statin within 14 days before inclusion.
Descrição

Anti-tumor necrosis factor therapy | Biological treatment | Biological agents Tumor necrosis factor alpha inhibitors Targeting Rheumatoid Arthritis | Medical contraindication Simvastatin | Statins

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0281481
UMLS CUI [2]
C1531518
UMLS CUI [3,1]
C0005515
UMLS CUI [3,2]
C3653350
UMLS CUI [3,3]
C1521840
UMLS CUI [3,4]
C0003873
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0074554
UMLS CUI [5]
C0360714
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descrição

Study Subject Participation Status | Considerations Additional

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Rheumatoid Arthritis NCT02017639

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Body Weight | Gender
Item
male or female, between 18 and 75 years of age, inclusive. body weight between 50.0 and 120.0 kg, inclusive, if male, and between 40.0 and 110.0 kg, inclusive, if female.
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Rheumatoid Arthritis Disease length | Rheumatoid Arthritis Functional Status Class | Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe
Item
diagnosis of ra, according to the acr/european league against rheumatism (eular) 2010 rheumatoid arthritis classification criteria with ≥ 3 months disease duration, acr class i-iii functional status, based on 1991 revised criteria (appendix b, 5). moderate-to-severely active ra, defined as:
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0598463 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
C2368567 (UMLS CUI [3])
C0003873 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Measurement of C-reactive protein using high sensitivity technique
Item
o high sensitivity c-reactive protein (hs-crp) ≥ 6 mg/l
boolean
C4040318 (UMLS CUI [1])
Laboratory Results Normal Range
Item
laboratory parameters within the normal range (or defined screening threshold for the investigator site), unless the investigator considers an abnormality to be clinically irrelevant for ra patients; however following lab values must be met:
boolean
C1254595 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Hemoglobin measurement
Item
hemoglobin >8.5 g/dl
boolean
C0518015 (UMLS CUI [1])
White Blood Cell Count procedure
Item
white blood cells >3000/mm3
boolean
C0023508 (UMLS CUI [1])
Neutrophil count
Item
neutrophils >2000/mm3
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >150 000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity Adverse effects Study Subject Participation Status
Item
prior or current significant concomitant illness(es) that, according to investigator's judgment, would adversely affect the patient's participation in the study.
boolean
C0009488 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Unwilling | Childbearing Potential Pregnancy Tests Unable
Item
women of childbearing potential not protected by highly-effective contraceptive method(s) of birth control (as defined in the informed consent form), and/or who are unwilling or unable to be tested for pregnancy.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs | Therapy, Investigational
Item
participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening, whichever is longer.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Tuberculosis | Therapeutic procedure Incomplete Tuberculosis | Chronic infectious disease | Communicable Disease | Arthropathy Autoimmune | Inflammatory joint disease Systemic | Arthropathy Localized | Exception Rheumatoid Arthritis
Item
patients with active tb or a history of incompletely treated tb. history of chronic infection or active infection. history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than ra.
boolean
C0041296 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
C0041296 (UMLS CUI [2,3])
C0151317 (UMLS CUI [3])
C0009450 (UMLS CUI [4])
C0022408 (UMLS CUI [5,1])
C0004364 (UMLS CUI [5,2])
C0683381 (UMLS CUI [6,1])
C0205373 (UMLS CUI [6,2])
C0022408 (UMLS CUI [7,1])
C0392752 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0003873 (UMLS CUI [8,2])
Systemic allergic reaction Biological agents | Exception Allergic Reaction Injection site Localized
Item
a systemic hypersensitivity reaction, other than localized injection site reaction, to any biologic drug.
boolean
C1736167 (UMLS CUI [1,1])
C0005515 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1527304 (UMLS CUI [2,2])
C2700396 (UMLS CUI [2,3])
C0392752 (UMLS CUI [2,4])
Substance Use Disorders | Interstitial Lung Disease High Resolution Computed Tomography | Interstitial Lung Disease Biopsy of lung | With consistency Pulmonary function tests | With consistency Clinical findings
Item
history or presence of drug or alcohol abuse. prior or current interstitial lung disease diagnosed by high resolution computed tomography and/or lung biopsy with consistent findings on pulmonary function tests and corroborating clinical findings.
boolean
C0038586 (UMLS CUI [1])
C0206062 (UMLS CUI [2,1])
C1512457 (UMLS CUI [2,2])
C0206062 (UMLS CUI [3,1])
C0189485 (UMLS CUI [3,2])
C0522508 (UMLS CUI [4,1])
C0024119 (UMLS CUI [4,2])
C0522508 (UMLS CUI [5,1])
C0037088 (UMLS CUI [5,2])
Malignant Neoplasms | Lymphoproliferative Disorders | Exception Carcinoma in situ of uterine cervix Treated | Exception Squamous cell carcinoma of skin nonmetastatic treated | Exception Basal cell carcinoma nonmetastatic treated
Item
prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the screening visit.
boolean
C0006826 (UMLS CUI [1])
C0024314 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1518409 (UMLS CUI [4,3])
C1522326 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
C1518409 (UMLS CUI [5,3])
C1522326 (UMLS CUI [5,4])
DIABETES MELLITUS NOS UNCONTROLLED | Hemoglobin A1c measurement
Item
uncontrolled diabetes mellitus, defined as glycosylated hemoglobin (hba1c) ≥9% at the screening visit.
boolean
C0743131 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Anti-tumor necrosis factor therapy | Biological treatment | Biological agents Tumor necrosis factor alpha inhibitors Targeting Rheumatoid Arthritis | Medical contraindication Simvastatin | Statins
Item
current treatment with anti-tnf agents or other biologics. current treatment with ra-directed biologic agents with non- tnf-α antagonist. any contra-indications to simvastatin, according to the applicable labeling. current treatment with a statin within 14 days before inclusion.
boolean
C0281481 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0005515 (UMLS CUI [3,1])
C3653350 (UMLS CUI [3,2])
C1521840 (UMLS CUI [3,3])
C0003873 (UMLS CUI [3,4])
C1301624 (UMLS CUI [4,1])
C0074554 (UMLS CUI [4,2])
C0360714 (UMLS CUI [5])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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