ID

40745

Descrição

Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I; ODM derived from: https://clinicaltrials.gov/show/NCT01463488

Link

https://clinicaltrials.gov/show/NCT01463488

Palavras-chave

Versões (2)
  1. 06/05/2020 06/05/2020 -
  2. 07/05/2020 07/05/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de maio de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01463488

Inglês

Eligibility Knee Osteoarthritis NCT01463488

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of primary knee osteoarthritis, based upon the following:
Descrição

Primary osteoarthritis of knee

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2893931
x-ray or magnetic resonance imaging (mri) evidence within the last 6 months for joint space narrowing and osteophyte formation
Descrição

Narrowed joint space X-Ray Computed Tomography | Narrowed joint space MRI | Osteophyte Formation X-Ray Computed Tomography | Osteophyte Formation MRI

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1859695
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C1859695
UMLS CUI [2,2]
C0024485
UMLS CUI [3,1]
C1956089
UMLS CUI [3,2]
C0439634
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C1956089
UMLS CUI [4,2]
C0439634
UMLS CUI [4,3]
C0024485
patients will be kellgren and lawrence classification ii/iii, and total western ontario mcmaster (womac) score 24 -72.
Descrição

Kellgren-Lawrence score | WOMAC scale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3177117
UMLS CUI [2]
C3472647
patients fulfilling the american college of rheumatology clinical and radiographic criteria for osteoarthritis.
Descrição

ACR Criteria Osteoarthritis Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3273747
UMLS CUI [1,2]
C0029408
UMLS CUI [1,3]
C1550543
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients younger than 40 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
women of child bearing potential.
Descrição

Childbearing Potential

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3831118
women either sterilized for more than 3 months, or post-menopausal for more than 12 months. menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma fsh level >30 iu/l.
Descrição

Female Sterilization | Postmenopausal state | Age | Amenorrhea | Plasma FSH measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0002453
UMLS CUI [5]
C1269629
secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, paget's disease, ehlers-danlos syndrome, gaucher's disease, stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.
Descrição

Secondary osteoarthritis | Autoimmune Disease | Joint dysplasia | Osteonecrosis, aseptic | Acromegaly | Paget's disease | Ehlers-Danlos Syndrome | Gaucher Disease | Stickler syndrome | Joint infection | Hemophilia | Hemochromatosis | Calcium pyrophosphate deposition disease | Neurogenic arthropathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2732281
UMLS CUI [2]
C0004364
UMLS CUI [3]
C1395954
UMLS CUI [4]
C0391980
UMLS CUI [5]
C0001206
UMLS CUI [6]
C0029401
UMLS CUI [7]
C0013720
UMLS CUI [8]
C0017205
UMLS CUI [9]
C0265253
UMLS CUI [10]
C0157749
UMLS CUI [11]
C0684275
UMLS CUI [12]
C0018995
UMLS CUI [13]
C0553730
UMLS CUI [14]
C0003892
presence of local skin abnormality at the affected knee joint.
Descrição

Skin Abnormality Local | Knee joint Affected

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037268
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C0022745
UMLS CUI [2,2]
C0392760
intra-articular injection within 3 months.
Descrição

Intra-Articular Injection Recent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021488
UMLS CUI [1,2]
C0332185
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 Knee Osteoarthritis NCT01463488

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Primary osteoarthritis of knee
Item
diagnosis of primary knee osteoarthritis, based upon the following:
boolean
C2893931 (UMLS CUI [1])
Narrowed joint space X-Ray Computed Tomography | Narrowed joint space MRI | Osteophyte Formation X-Ray Computed Tomography | Osteophyte Formation MRI
Item
x-ray or magnetic resonance imaging (mri) evidence within the last 6 months for joint space narrowing and osteophyte formation
boolean
C1859695 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1859695 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C1956089 (UMLS CUI [3,1])
C0439634 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1956089 (UMLS CUI [4,1])
C0439634 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
Kellgren-Lawrence score | WOMAC scale
Item
patients will be kellgren and lawrence classification ii/iii, and total western ontario mcmaster (womac) score 24 -72.
boolean
C3177117 (UMLS CUI [1])
C3472647 (UMLS CUI [2])
ACR Criteria Osteoarthritis Fulfill
Item
patients fulfilling the american college of rheumatology clinical and radiographic criteria for osteoarthritis.
boolean
C3273747 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients younger than 40 years
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential
Item
women of child bearing potential.
boolean
C3831118 (UMLS CUI [1])
Female Sterilization | Postmenopausal state | Age | Amenorrhea | Plasma FSH measurement
Item
women either sterilized for more than 3 months, or post-menopausal for more than 12 months. menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma fsh level >30 iu/l.
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0002453 (UMLS CUI [4])
C1269629 (UMLS CUI [5])
Secondary osteoarthritis | Autoimmune Disease | Joint dysplasia | Osteonecrosis, aseptic | Acromegaly | Paget's disease | Ehlers-Danlos Syndrome | Gaucher Disease | Stickler syndrome | Joint infection | Hemophilia | Hemochromatosis | Calcium pyrophosphate deposition disease | Neurogenic arthropathy
Item
secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, paget's disease, ehlers-danlos syndrome, gaucher's disease, stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.
boolean
C2732281 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C1395954 (UMLS CUI [3])
C0391980 (UMLS CUI [4])
C0001206 (UMLS CUI [5])
C0029401 (UMLS CUI [6])
C0013720 (UMLS CUI [7])
C0017205 (UMLS CUI [8])
C0265253 (UMLS CUI [9])
C0157749 (UMLS CUI [10])
C0684275 (UMLS CUI [11])
C0018995 (UMLS CUI [12])
C0553730 (UMLS CUI [13])
C0003892 (UMLS CUI [14])
Skin Abnormality Local | Knee joint Affected
Item
presence of local skin abnormality at the affected knee joint.
boolean
C0037268 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0022745 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
Intra-Articular Injection Recent
Item
intra-articular injection within 3 months.
boolean
C0021488 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
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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