ID

31873

Beschreibung

A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab; ODM derived from: https://clinicaltrials.gov/show/NCT00808210

Link

https://clinicaltrials.gov/show/NCT00808210

Stichworte

Versionen (1)
  1. 05.10.18 05.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00808210

Englisch

Eligibility Rheumatoid Arthritis NCT00808210

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >= 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
current treatment for ra on an outpatient basis
Beschreibung

Therapeutic procedure Rheumatoid Arthritis | Outpatients

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003873
UMLS CUI [2]
C0029921
active disease
Beschreibung

Active disease

Datentyp

boolean

Alias
UMLS CUI [1]
C2707252
currently receiving 50 mg etanercept subcutaneously (sc) every week or 40 mg adalimumab sc every other week.
Beschreibung

Etanercept Subcutaneous U/week | Adalimumab Subcutaneous U/week

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0717758
UMLS CUI [1,2]
C1522438
UMLS CUI [1,3]
C0560588
UMLS CUI [2,1]
C1122087
UMLS CUI [2,2]
C1522438
UMLS CUI [2,3]
C0560588
considered by investigator to be a primary non-responder to their first anti-tnfî±
Beschreibung

Therapy non-responder Primary | Anti-tumor necrosis factor alpha drug First

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919875
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1562242
UMLS CUI [2,2]
C0205435
treatment for efficacy reasons
Beschreibung

Therapeutic procedure Efficacy Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1280519
UMLS CUI [1,3]
C0439849
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra
Beschreibung

Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis | Rheumatoid arthritis with systemic involvement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0035435
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
UMLS CUI [3]
C0494896
history of, or current, inflammatory joint disease other than ra (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)
Beschreibung

Inflammatory joint disease | Exception Rheumatoid Arthritis | Gout | Arthritis, Reactive | Arthritis, Psoriatic | Spondylarthropathy Seronegative | Lyme Disease | Systemic Autoimmune disease | Lupus Erythematosus, Systemic | Inflammatory Bowel Diseases | Scleroderma | Myositis | Mixed Connective Tissue Disease | Overlap syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
UMLS CUI [3]
C0018099
UMLS CUI [4]
C0085435
UMLS CUI [5]
C0003872
UMLS CUI [6,1]
C0949691
UMLS CUI [6,2]
C0521144
UMLS CUI [7]
C0024198
UMLS CUI [8]
C2895206
UMLS CUI [9]
C0024141
UMLS CUI [10]
C0021390
UMLS CUI [11]
C0011644
UMLS CUI [12]
C0027121
UMLS CUI [13]
C0026272
UMLS CUI [14]
C0410000
previous treatment with a any biologic therapy for ra (including investigational products with the exception of etanercept or adalimumab
Beschreibung

Biological treatment Rheumatoid Arthritis | Investigational New Drugs | Exception Etanercept | Exception Adalimumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1531518
UMLS CUI [1,2]
C0003873
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0717758
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1122087
treatment with more than one prior anti-tnfî± therapy
Beschreibung

Anti-TNF-alpha therapy Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0281481
UMLS CUI [1,2]
C1265611
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00808210

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Rheumatoid Arthritis | Outpatients
Item
current treatment for ra on an outpatient basis
boolean
C0087111 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0029921 (UMLS CUI [2])
Active disease
Item
active disease
boolean
C2707252 (UMLS CUI [1])
Etanercept Subcutaneous U/week | Adalimumab Subcutaneous U/week
Item
currently receiving 50 mg etanercept subcutaneously (sc) every week or 40 mg adalimumab sc every other week.
boolean
C0717758 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C0560588 (UMLS CUI [1,3])
C1122087 (UMLS CUI [2,1])
C1522438 (UMLS CUI [2,2])
C0560588 (UMLS CUI [2,3])
Therapy non-responder Primary | Anti-tumor necrosis factor alpha drug First
Item
considered by investigator to be a primary non-responder to their first anti-tnfî±
boolean
C0919875 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1562242 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
Therapeutic procedure Efficacy Related
Item
treatment for efficacy reasons
boolean
C0087111 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis | Rheumatoid arthritis with systemic involvement
Item
rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0494896 (UMLS CUI [3])
Inflammatory joint disease | Exception Rheumatoid Arthritis | Gout | Arthritis, Reactive | Arthritis, Psoriatic | Spondylarthropathy Seronegative | Lyme Disease | Systemic Autoimmune disease | Lupus Erythematosus, Systemic | Inflammatory Bowel Diseases | Scleroderma | Myositis | Mixed Connective Tissue Disease | Overlap syndrome
Item
history of, or current, inflammatory joint disease other than ra (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0018099 (UMLS CUI [3])
C0085435 (UMLS CUI [4])
C0003872 (UMLS CUI [5])
C0949691 (UMLS CUI [6,1])
C0521144 (UMLS CUI [6,2])
C0024198 (UMLS CUI [7])
C2895206 (UMLS CUI [8])
C0024141 (UMLS CUI [9])
C0021390 (UMLS CUI [10])
C0011644 (UMLS CUI [11])
C0027121 (UMLS CUI [12])
C0026272 (UMLS CUI [13])
C0410000 (UMLS CUI [14])
Biological treatment Rheumatoid Arthritis | Investigational New Drugs | Exception Etanercept | Exception Adalimumab
Item
previous treatment with a any biologic therapy for ra (including investigational products with the exception of etanercept or adalimumab
boolean
C1531518 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0717758 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1122087 (UMLS CUI [4,2])
Anti-TNF-alpha therapy Quantity
Item
treatment with more than one prior anti-tnfî± therapy
boolean
C0281481 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
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