ID

40419

Beskrivning

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT01636843

Länk

https://clinicaltrials.gov/show/NCT01636843

Nyckelord

Versioner (1)
  1. 2020-04-19 2020-04-19 -
Rättsinnehavare

See clinicaltrials.gov

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19 april 2020

DOI

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Creative Commons BY 4.0
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Eligibility Inflammation NCT01636843

Engelsk

Eligibility Inflammation NCT01636843

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent must be obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
a documented diagnosis of ra at least 6 months prior to screening visit, according to the american college of rheumatology (eular/acr 2010 criteria) or by standard criteria (acr 1987) if diagnosis was made earlier than 2010
Beskrivning

Rheumatoid Arthritis Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0449238
active ra, characterised by: a. more than 5 tender and more than 5 swollen joints based on a 28 joint count b. c-reactive protein (crp) above or equal to 1.0 mg/dl (10 mg/l)
Beskrivning

Tender 28 joint count | Swollen 28 joint count | C-reactive protein measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C2711398
UMLS CUI [2]
C2711873
UMLS CUI [3]
C0201657
patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. patient can be on mtx as low as 10 mg/week only if due to mtx intolerance b. hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit
Beskrivning

Methotrexate | Hydroxychloroquine | Chloroquine | Hydroxychloroquine Absent | Chloroquine Absent | Methotrexate Dose | Relationship Intolerance to Methotrexate | Hydroxychloroquine Oral Dose | Chloroquine Oral Dose

Datatyp

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0020336
UMLS CUI [3]
C0008269
UMLS CUI [4,1]
C0020336
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0008269
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0025677
UMLS CUI [6,2]
C0178602
UMLS CUI [7,1]
C0439849
UMLS CUI [7,2]
C1744706
UMLS CUI [7,3]
C0025677
UMLS CUI [8,1]
C0020336
UMLS CUI [8,2]
C1527415
UMLS CUI [8,3]
C0178602
UMLS CUI [9,1]
C0008269
UMLS CUI [9,2]
C1527415
UMLS CUI [9,3]
C0178602
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with arthritis due to other autoimmune diseases than ra
Beskrivning

Arthritis Due to Autoimmune Disease | Exception Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0004364
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
Beskrivning

Bacterial Infections | Exception resolved | Recurrent infections | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1514893
UMLS CUI [3]
C0239998
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0231203
UMLS CUI [4,3]
C0151317
UMLS CUI [5]
C0006267
UMLS CUI [6]
C0008707
history of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy
Beskrivning

Systemic viral infection Severe | Systemic mycosis Severe | Exception resolved

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4285789
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0553576
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1514893
patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
Beskrivning

Malignant Neoplasms | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Carcinoma in situ of uterine cervix Cured

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1880198
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1880198
females of childbearing potential who are pregnant or breast feeding or intend to become pregnant
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
any other disease or clinically significant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective
Beskrivning

Disease At risk Patient safety | Laboratory test result abnormal At risk Patient safety | Disease Interferes with Study Subject Participation Status | Laboratory test result abnormal Interferes with Study Subject Participation Status | Disease At risk Completion of clinical trial | Laboratory test result abnormal At risk Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0438215
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C2732579
UMLS CUI [6,1]
C0438215
UMLS CUI [6,2]
C1444641
UMLS CUI [6,3]
C2732579
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Similar models

Eligibility Inflammation NCT01636843

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent must be obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Rheumatoid Arthritis Duration
Item
a documented diagnosis of ra at least 6 months prior to screening visit, according to the american college of rheumatology (eular/acr 2010 criteria) or by standard criteria (acr 1987) if diagnosis was made earlier than 2010
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Tender 28 joint count | Swollen 28 joint count | C-reactive protein measurement
Item
active ra, characterised by: a. more than 5 tender and more than 5 swollen joints based on a 28 joint count b. c-reactive protein (crp) above or equal to 1.0 mg/dl (10 mg/l)
boolean
C2711398 (UMLS CUI [1])
C2711873 (UMLS CUI [2])
C0201657 (UMLS CUI [3])
Methotrexate | Hydroxychloroquine | Chloroquine | Hydroxychloroquine Absent | Chloroquine Absent | Methotrexate Dose | Relationship Intolerance to Methotrexate | Hydroxychloroquine Oral Dose | Chloroquine Oral Dose
Item
patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. patient can be on mtx as low as 10 mg/week only if due to mtx intolerance b. hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit
boolean
C0025677 (UMLS CUI [1])
C0020336 (UMLS CUI [2])
C0008269 (UMLS CUI [3])
C0020336 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0008269 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0025677 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0439849 (UMLS CUI [7,1])
C1744706 (UMLS CUI [7,2])
C0025677 (UMLS CUI [7,3])
C0020336 (UMLS CUI [8,1])
C1527415 (UMLS CUI [8,2])
C0178602 (UMLS CUI [8,3])
C0008269 (UMLS CUI [9,1])
C1527415 (UMLS CUI [9,2])
C0178602 (UMLS CUI [9,3])
Item Group
C0680251 (UMLS CUI)
Arthritis Due to Autoimmune Disease | Exception Rheumatoid Arthritis
Item
patients with arthritis due to other autoimmune diseases than ra
boolean
C0003864 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0004364 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Bacterial Infections | Exception resolved | Recurrent infections | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis
Item
any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
boolean
C0004623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C0239998 (UMLS CUI [3])
C0348080 (UMLS CUI [4,1])
C0231203 (UMLS CUI [4,2])
C0151317 (UMLS CUI [4,3])
C0006267 (UMLS CUI [5])
C0008707 (UMLS CUI [6])
Systemic viral infection Severe | Systemic mycosis Severe | Exception resolved
Item
history of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy
boolean
C4285789 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0553576 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1514893 (UMLS CUI [3,2])
Malignant Neoplasms | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Carcinoma in situ of uterine cervix Cured
Item
patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1880198 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
females of childbearing potential who are pregnant or breast feeding or intend to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Disease At risk Patient safety | Laboratory test result abnormal At risk Patient safety | Disease Interferes with Study Subject Participation Status | Laboratory test result abnormal Interferes with Study Subject Participation Status | Disease At risk Completion of clinical trial | Laboratory test result abnormal At risk Completion of clinical trial
Item
any other disease or clinically significant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0438215 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C2732579 (UMLS CUI [5,3])
C0438215 (UMLS CUI [6,1])
C1444641 (UMLS CUI [6,2])
C2732579 (UMLS CUI [6,3])
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