ID

36844

Beschreibung

First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement; ODM derived from: https://clinicaltrials.gov/show/NCT02491281

Link

https://clinicaltrials.gov/show/NCT02491281

Stichworte

Versionen (1)
  1. 15.06.19 15.06.19 -
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See clinicaltrials.gov

Hochgeladen am

15. Juni 2019

DOI

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Eligibility Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery NCT02491281

Englisch

Eligibility Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery NCT02491281

1 Formulare  
Criteria
Beschreibung

Criteria

male and female patients age 50 to 75 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
Beschreibung

Age | Good health Medical History | Good health Physical Examination | Good health Vital signs | Good health Electrocardiography | Good health Laboratory Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C3813622
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C3813622
UMLS CUI [3,2]
C0031809
UMLS CUI [4,1]
C3813622
UMLS CUI [4,2]
C0518766
UMLS CUI [5,1]
C3813622
UMLS CUI [5,2]
C1623258
UMLS CUI [6,1]
C3813622
UMLS CUI [6,2]
C0022885
patients diagnosed with primary osteoarthritis of the knee assessed locally with a disease grade 3 or 4 as determined by the kellgren & lawrence scale for whom a total knee replacement is planned
Beschreibung

Localized primary osteoarthritis of knee Kellgren-Lawrence score | Knee Replacement Arthroplasty Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2103692
UMLS CUI [1,2]
C3177117
UMLS CUI [2,1]
C0086511
UMLS CUI [2,2]
C1301732
general health status acceptable for total knee replacement surgery in the opinion of the investigator
Beschreibung

Health Status Acceptable Knee Replacement Arthroplasty

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C1879533
UMLS CUI [1,3]
C0086511
stable medications consistent with standard of care (such as appropriate pain medication, antibiotics prophylaxis) are acceptable within 6 month prior enrollment
Beschreibung

Pharmaceutical Preparations Stable Consistent with Standard of Care | Analgesics | Antibiotic Prophylaxis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C2936643
UMLS CUI [2]
C0002771
UMLS CUI [3]
C0282638
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
presence of inflammatory arthropathy (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout), active acute or chronic infection, or systemic cartilage disorder
Beschreibung

Arthritis | Rheumatoid Arthritis | Arthritis, Psoriatic | Ankylosing spondylitis | Gout | Communicable Disease | Chronic infectious disease | Cartilage Disease Systemic

Datentyp

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0003872
UMLS CUI [4]
C0038013
UMLS CUI [5]
C0018099
UMLS CUI [6]
C0009450
UMLS CUI [7]
C0151317
UMLS CUI [8,1]
C0007302
UMLS CUI [8,2]
C0205373
prior cartilage repair surgery, e.g. microfracture, autologous cartilage implantation (aci) or else, at the same knee
Beschreibung

Cartilage repair Knee Same | Microfractures Knee Same | Autologous chondrocyte implantation Knee Same

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1112785
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0445247
UMLS CUI [2,1]
C1265651
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C0445247
UMLS CUI [3,1]
C1504240
UMLS CUI [3,2]
C0022742
UMLS CUI [3,3]
C0445247
any surgical therapy or local treatment i.a. into the knee (viscosupplementation) to the knee within 6 months prior to enrollment
Beschreibung

Operative procedure on knee | Local Therapy Intra-articular Knee | Viscosupplementation

Datentyp

boolean

Alias
UMLS CUI [1]
C0187769
UMLS CUI [2,1]
C1517925
UMLS CUI [2,2]
C0442108
UMLS CUI [2,3]
C0022742
UMLS CUI [3]
C2350507
bmi > 35; presence of uncontrolled diabetes or hyperthyroidism
Beschreibung

Body mass index | Diabetic - poor control | Hyperthyroidism Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0421258
UMLS CUI [3,1]
C0020550
UMLS CUI [3,2]
C0205318
large effusion in the knee to be replaced, <1 cm fluid in the suprapatellar space at the midline
Beschreibung

Effusion Large Knee Involved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013687
UMLS CUI [1,2]
C0549177
UMLS CUI [1,3]
C0022742
UMLS CUI [1,4]
C1314939
corticosteroid use by any route except topical within 3 months prior to enrollment
Beschreibung

Adrenal Cortex Hormones Drug Administration Route Any | Exception Topical Route of Drug Administration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1522168
history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
Beschreibung

Malignant Neoplasms Organ system | Exception Basal cell carcinoma Localized Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Localized Untreated | Exception Carcinoma in situ of uterine cervix Untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0460002
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0392752
UMLS CUI [2,4]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C0392752
UMLS CUI [4,4]
C0332155
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C0332155
pregnant or nursing (lactating) women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
Beschreibung

Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
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Ähnliche Modelle

Eligibility Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery NCT02491281

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age | Good health Medical History | Good health Physical Examination | Good health Vital signs | Good health Electrocardiography | Good health Laboratory Procedures
Item
male and female patients age 50 to 75 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
boolean
C0001779 (UMLS CUI [1])
C3813622 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C3813622 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C3813622 (UMLS CUI [4,1])
C0518766 (UMLS CUI [4,2])
C3813622 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C3813622 (UMLS CUI [6,1])
C0022885 (UMLS CUI [6,2])
Localized primary osteoarthritis of knee Kellgren-Lawrence score | Knee Replacement Arthroplasty Planned
Item
patients diagnosed with primary osteoarthritis of the knee assessed locally with a disease grade 3 or 4 as determined by the kellgren & lawrence scale for whom a total knee replacement is planned
boolean
C2103692 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C0086511 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Health Status Acceptable Knee Replacement Arthroplasty
Item
general health status acceptable for total knee replacement surgery in the opinion of the investigator
boolean
C0018759 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0086511 (UMLS CUI [1,3])
Pharmaceutical Preparations Stable Consistent with Standard of Care | Analgesics | Antibiotic Prophylaxis
Item
stable medications consistent with standard of care (such as appropriate pain medication, antibiotics prophylaxis) are acceptable within 6 month prior enrollment
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C2936643 (UMLS CUI [1,4])
C0002771 (UMLS CUI [2])
C0282638 (UMLS CUI [3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Arthritis | Rheumatoid Arthritis | Arthritis, Psoriatic | Ankylosing spondylitis | Gout | Communicable Disease | Chronic infectious disease | Cartilage Disease Systemic
Item
presence of inflammatory arthropathy (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout), active acute or chronic infection, or systemic cartilage disorder
boolean
C0003864 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0003872 (UMLS CUI [3])
C0038013 (UMLS CUI [4])
C0018099 (UMLS CUI [5])
C0009450 (UMLS CUI [6])
C0151317 (UMLS CUI [7])
C0007302 (UMLS CUI [8,1])
C0205373 (UMLS CUI [8,2])
Cartilage repair Knee Same | Microfractures Knee Same | Autologous chondrocyte implantation Knee Same
Item
prior cartilage repair surgery, e.g. microfracture, autologous cartilage implantation (aci) or else, at the same knee
boolean
C1112785 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C1265651 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0445247 (UMLS CUI [2,3])
C1504240 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])
C0445247 (UMLS CUI [3,3])
Operative procedure on knee | Local Therapy Intra-articular Knee | Viscosupplementation
Item
any surgical therapy or local treatment i.a. into the knee (viscosupplementation) to the knee within 6 months prior to enrollment
boolean
C0187769 (UMLS CUI [1])
C1517925 (UMLS CUI [2,1])
C0442108 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
C2350507 (UMLS CUI [3])
Body mass index | Diabetic - poor control | Hyperthyroidism Uncontrolled
Item
bmi > 35; presence of uncontrolled diabetes or hyperthyroidism
boolean
C1305855 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
C0020550 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Effusion Large Knee Involved
Item
large effusion in the knee to be replaced, <1 cm fluid in the suprapatellar space at the midline
boolean
C0013687 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C1314939 (UMLS CUI [1,4])
Adrenal Cortex Hormones Drug Administration Route Any | Exception Topical Route of Drug Administration
Item
corticosteroid use by any route except topical within 3 months prior to enrollment
boolean
C0001617 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1522168 (UMLS CUI [2,2])
Malignant Neoplasms Organ system | Exception Basal cell carcinoma Localized Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Localized Untreated | Exception Carcinoma in situ of uterine cervix Untreated
Item
history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
boolean
C0006826 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0392752 (UMLS CUI [2,3])
C1522326 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C0392752 (UMLS CUI [4,3])
C0332155 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C0332155 (UMLS CUI [5,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential
Item
women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
boolean
C3831118 (UMLS CUI [1])
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