ID

22983

Beskrivning

Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00669942

Länk

https://clinicaltrials.gov/show/NCT00669942

Nyckelord

Versioner (1)
  1. 2017-06-19 2017-06-19 -
Uppladdad den

19 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00669942

Engelsk

Eligibility Rheumatoid Arthritis NCT00669942

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients with active rheumatoid arthritis in combination with a stable dose of methotrexate aged 18-75 years may participate in this trial.
Beskrivning

Rheumatoid Arthritis | Methotrexate Dose Stable | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0001779
post menopausal or surgically sterile female patients are allowed. women of child-bearing potential may participate if they are on a stable dose of methotrexate and if they are practicing effective contraception for at least 6 months prior to screening, willing to use 2 forms of contraception, including at least 1 barrier method during the study and for at least 2 months following the completion/discontinuation of the study.
Beskrivning

Postmenopausal state | Female Sterilization | Childbearing Potential Methotrexate Dose Stable | Childbearing Potential Contraceptive methods | Contraceptive methods Quantity | Contraception, Barrier

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0025677
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205360
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C0700589
UMLS CUI [5,2]
C1265611
UMLS CUI [6]
C0004764
patients must have a diagnosis of active rheumatoid arthritis of stages i, ii or iii (acr 1987 revised classification for criteria for ra). disease duration of at least 6 months prior to randomization is essential;
Beskrivning

Rheumatoid Arthritis Class Functional | Rheumatoid Arthritis disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0205245
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0872146
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current treatment with anti-tnf-α or anti il-1 therapy (or other biological therapy).
Beskrivning

anti-tumor necrosis factor therapy | Therapeutic procedure Against Interleukin-1 | Biological treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0281481
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0021755
UMLS CUI [3]
C1531518
patients with congestive heart failure or poorly controlled diabetes mellitus (hba1c value ≥10%).
Beskrivning

Congestive heart failure | Diabetes mellitus poor control | Glycosylated hemoglobin A

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0860161
UMLS CUI [3]
C0019018
presence of any major chronic inflammatory autoimmune diseases like psoriasis, psoriatic arthritis, spondyloarthropathy, inflammatory bowel disease or sle that can mimic rheumatoid arthritis diagnosis or that can interfere with efficacy evaluation in the study.
Beskrivning

Autoimmune Diseases inflammatory chronic major | Psoriasis | Arthritis, Psoriatic | Spondylarthropathy | Inflammatory Bowel Diseases | Lupus Erythematosus, Systemic | Autoimmune Disease Interferes with Clinical Trial Evaluation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0333348
UMLS CUI [1,3]
C0205191
UMLS CUI [1,4]
C0205164
UMLS CUI [2]
C0033860
UMLS CUI [3]
C0003872
UMLS CUI [4]
C0949691
UMLS CUI [5]
C0021390
UMLS CUI [6]
C0024141
UMLS CUI [7,1]
C0004364
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0008976
UMLS CUI [7,4]
C0220825
history of renal trauma, glomerulonephritis or patient with one kidney.
Beskrivning

Trauma renal | Glomerulonephritis | Absence of one kidney

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3714660
UMLS CUI [1,2]
C0022646
UMLS CUI [2]
C0017658
UMLS CUI [3]
C0426706
pregnant or breastfeeding women will be excluded.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
a positive tuberculin skin test.
Beskrivning

Tuberculin (skin test) positive

Datatyp

boolean

Alias
UMLS CUI [1]
C3161220
other protocol-defined inclusion/exclusion criteria may apply.
Beskrivning

Clinical Trial Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Rheumatoid Arthritis NCT00669942

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis | Methotrexate Dose Stable | Age
Item
male and female patients with active rheumatoid arthritis in combination with a stable dose of methotrexate aged 18-75 years may participate in this trial.
boolean
C0003873 (UMLS CUI [1])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
Postmenopausal state | Female Sterilization | Childbearing Potential Methotrexate Dose Stable | Childbearing Potential Contraceptive methods | Contraceptive methods Quantity | Contraception, Barrier
Item
post menopausal or surgically sterile female patients are allowed. women of child-bearing potential may participate if they are on a stable dose of methotrexate and if they are practicing effective contraception for at least 6 months prior to screening, willing to use 2 forms of contraception, including at least 1 barrier method during the study and for at least 2 months following the completion/discontinuation of the study.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0025677 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0700589 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0004764 (UMLS CUI [6])
Rheumatoid Arthritis Class Functional | Rheumatoid Arthritis disease length
Item
patients must have a diagnosis of active rheumatoid arthritis of stages i, ii or iii (acr 1987 revised classification for criteria for ra). disease duration of at least 6 months prior to randomization is essential;
boolean
C0003873 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
C0003873 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
anti-tumor necrosis factor therapy | Therapeutic procedure Against Interleukin-1 | Biological treatment
Item
current treatment with anti-tnf-α or anti il-1 therapy (or other biological therapy).
boolean
C0281481 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0021755 (UMLS CUI [2,3])
C1531518 (UMLS CUI [3])
Congestive heart failure | Diabetes mellitus poor control | Glycosylated hemoglobin A
Item
patients with congestive heart failure or poorly controlled diabetes mellitus (hba1c value ≥10%).
boolean
C0018802 (UMLS CUI [1])
C0860161 (UMLS CUI [2])
C0019018 (UMLS CUI [3])
Autoimmune Diseases inflammatory chronic major | Psoriasis | Arthritis, Psoriatic | Spondylarthropathy | Inflammatory Bowel Diseases | Lupus Erythematosus, Systemic | Autoimmune Disease Interferes with Clinical Trial Evaluation
Item
presence of any major chronic inflammatory autoimmune diseases like psoriasis, psoriatic arthritis, spondyloarthropathy, inflammatory bowel disease or sle that can mimic rheumatoid arthritis diagnosis or that can interfere with efficacy evaluation in the study.
boolean
C0004364 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C0033860 (UMLS CUI [2])
C0003872 (UMLS CUI [3])
C0949691 (UMLS CUI [4])
C0021390 (UMLS CUI [5])
C0024141 (UMLS CUI [6])
C0004364 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0008976 (UMLS CUI [7,3])
C0220825 (UMLS CUI [7,4])
Trauma renal | Glomerulonephritis | Absence of one kidney
Item
history of renal trauma, glomerulonephritis or patient with one kidney.
boolean
C3714660 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C0017658 (UMLS CUI [2])
C0426706 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women will be excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tuberculin (skin test) positive
Item
a positive tuberculin skin test.
boolean
C3161220 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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