ID

31855

Beschreibung

An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.; ODM derived from: https://clinicaltrials.gov/show/NCT00750880

Link

https://clinicaltrials.gov/show/NCT00750880

Stichworte

Versionen (1)
  1. 04.10.18 04.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. Oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00750880

Englisch

Eligibility Rheumatoid Arthritis NCT00750880

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and non-pregnant or nursing female patients >=18 years of age;
Beschreibung

Gender | Pregnancy Absent | Breast Feeding Absent | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0001779
body weight <=150kg;
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
moderate to severe active ra (das28 >=3.2) of >=6 months duration;
Beschreibung

Rheumatoid arthritis moderate Disease activity score das28 Duration | Rheumatoid Arthritis Severe Disease activity score das28 Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368567
UMLS CUI [1,2]
C4481729
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C4481729
UMLS CUI [2,4]
C0449238
on >=1 non-biologic dmards at a stable dose for a period of >= 8 weeks prior to start of treatment;
Beschreibung

DMARDs Quantity Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
inadequate clinical response to a stable dose of non-biologic dmard or anti-tnf therapy;
Beschreibung

DMARD Dose Stable | Anti-tumor necrosis factor therapy | Clinical Response Inadequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0281481
UMLS CUI [3,1]
C4055223
UMLS CUI [3,2]
C0205412
if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.
Beschreibung

Adrenal Cortex Hormones Oral Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
Beschreibung

Major surgery | Operation on joint | Major surgery Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0185132
UMLS CUI [3,1]
C0679637
UMLS CUI [3,2]
C1301732
rheumatic autoimmune disease other than ra;
Beschreibung

Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0035435
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
prior history of, or current inflammatory joint disease other than ra;
Beschreibung

Inflammatory joint disease | Exception Rheumatoid Arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
functional class iv as defined by the acr classification of functional status in ra.
Beschreibung

Rheumatoid Arthritis Functional Status Class

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00750880

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Pregnancy Absent | Breast Feeding Absent | Age
Item
male and non-pregnant or nursing female patients >=18 years of age;
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
Body Weight
Item
body weight <=150kg;
boolean
C0005910 (UMLS CUI [1])
Rheumatoid arthritis moderate Disease activity score das28 Duration | Rheumatoid Arthritis Severe Disease activity score das28 Duration
Item
moderate to severe active ra (das28 >=3.2) of >=6 months duration;
boolean
C2368567 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4481729 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
DMARDs Quantity Dose Stable
Item
on >=1 non-biologic dmards at a stable dose for a period of >= 8 weeks prior to start of treatment;
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
DMARD Dose Stable | Anti-tumor necrosis factor therapy | Clinical Response Inadequate
Item
inadequate clinical response to a stable dose of non-biologic dmard or anti-tnf therapy;
boolean
C0242708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0281481 (UMLS CUI [2])
C4055223 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Adrenal Cortex Hormones Oral Dose Stable
Item
if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Major surgery | Operation on joint | Major surgery Planned
Item
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
boolean
C0679637 (UMLS CUI [1])
C0185132 (UMLS CUI [2])
C0679637 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis
Item
rheumatic autoimmune disease other than ra;
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
prior history of, or current inflammatory joint disease other than ra;
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Rheumatoid Arthritis Functional Status Class
Item
functional class iv as defined by the acr classification of functional status in ra.
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
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