ID

19177

Description

A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00077870

Link

https://clinicaltrials.gov/show/NCT00077870

Keywords

Versions (1)
  1. 12/10/16 12/10/16 -
Uploaded on

December 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00077870

English

Eligibility Rheumatoid Arthritis NCT00077870

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability and willingness to provide written informed consent and to comply with the requirements of the protocol
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
diagnosis of ra for at least 6 months according to the revised 1987 acr criteria for the classification of ra
Description

Rheumatoid Arthritis disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
positive serum rf
Description

Rheumatoid Factor Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201660
current treatment for ra on an outpatient basis
Description

Therapeutic procedure Rheumatoid Arthritis Outpatient

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003873
UMLS CUI [1,3]
C0029921
contact your local site that is listed for more inclusion criteria
Description

Inclusion criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization
Description

Operative Surgical Procedure bone | Operation on joint | Arthrodesis | Operation on joint Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0262950
UMLS CUI [2]
C0185132
UMLS CUI [3]
C0003881
UMLS CUI [4,1]
C0185132
UMLS CUI [4,2]
C1301732
rheumatic autoimmune disease other than ra or significant systemic involvement secondary to ra (e.g., vasculitis, pulmonary fibrosis, or felty�s syndrome)
Description

Autoimmune Disease Rheumatic | Rheumatoid Arthritis | Rheumatoid arthritis with systemic involvement | Vasculitis | Pulmonary Fibrosis | Felty Syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0035435
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0494896
UMLS CUI [4]
C0042384
UMLS CUI [5]
C0034069
UMLS CUI [6]
C0015773
functional class iv as defined by the acr classification of functional status in ra
Description

Rheumatoid Arthritis Class Functional

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0205245
history of or current inflammatory joint disease other than ra (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, lyme disease) or other systemic rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome)
Description

inflammatory joint disease | Rheumatoid Arthritis | Gout | Arthritis, Reactive | Arthritis, Psoriatic | Spondylarthropathy Seronegative | Lyme Disease | Rheumatic disorder Systemic | Lupus Erythematosus, Systemic | Inflammatory Bowel Diseases | Scleroderma | Myositis | Overlap syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [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 [8,1]
C3495832
UMLS CUI [8,2]
C0205373
UMLS CUI [9]
C0024141
UMLS CUI [10]
C0021390
UMLS CUI [11]
C0011644
UMLS CUI [12]
C0027121
UMLS CUI [13]
C0410000
contact your local site that is listed for more exclusion criteria
Description

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Rheumatoid Arthritis NCT00077870

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Protocol Compliance
Item
ability and willingness to provide written informed consent and to comply with the requirements of the protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Rheumatoid Arthritis disease length
Item
diagnosis of ra for at least 6 months according to the revised 1987 acr criteria for the classification of ra
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Rheumatoid Factor Measurement
Item
positive serum rf
boolean
C0201660 (UMLS CUI [1])
Therapeutic procedure Rheumatoid Arthritis Outpatient
Item
current treatment for ra on an outpatient basis
boolean
C0087111 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0029921 (UMLS CUI [1,3])
Inclusion criteria Additional
Item
contact your local site that is listed for more inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Operative Surgical Procedure bone | Operation on joint | Arthrodesis | Operation on joint Planned
Item
bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization
boolean
C0543467 (UMLS CUI [1,1])
C0262950 (UMLS CUI [1,2])
C0185132 (UMLS CUI [2])
C0003881 (UMLS CUI [3])
C0185132 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Autoimmune Disease Rheumatic | Rheumatoid Arthritis | Rheumatoid arthritis with systemic involvement | Vasculitis | Pulmonary Fibrosis | Felty Syndrome
Item
rheumatic autoimmune disease other than ra or significant systemic involvement secondary to ra (e.g., vasculitis, pulmonary fibrosis, or felty�s syndrome)
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2])
C0494896 (UMLS CUI [3])
C0042384 (UMLS CUI [4])
C0034069 (UMLS CUI [5])
C0015773 (UMLS CUI [6])
Rheumatoid Arthritis Class Functional
Item
functional class iv as defined by the acr classification of functional status in ra
boolean
C0003873 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
inflammatory joint disease | Rheumatoid Arthritis | Gout | Arthritis, Reactive | Arthritis, Psoriatic | Spondylarthropathy Seronegative | Lyme Disease | Rheumatic disorder Systemic | Lupus Erythematosus, Systemic | Inflammatory Bowel Diseases | Scleroderma | Myositis | 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 rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome)
boolean
C0683381 (UMLS CUI [1])
C0003873 (UMLS CUI [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])
C3495832 (UMLS CUI [8,1])
C0205373 (UMLS CUI [8,2])
C0024141 (UMLS CUI [9])
C0021390 (UMLS CUI [10])
C0011644 (UMLS CUI [11])
C0027121 (UMLS CUI [12])
C0410000 (UMLS CUI [13])
Exclusion Criteria Additional
Item
contact your local site that is listed for more exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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