ID

34556

Description

Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01347983

Link

https://clinicaltrials.gov/show/NCT01347983

Keywords

  1. 1/19/19 1/19/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 19, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT01347983

Eligibility Rheumatoid Arthritis NCT01347983

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who had completed at least 5 out of the 7 visits scheduled for weeks 2, 4, 8, 12, 16, 20 and 24 in the tocilizumab phase iiib study(mra230tw).
Description

ID.1

Data type

boolean

patients assigned in the phase iiib study(mra230tw), who had received scheduled dose for at least 16 weeks but still failed to achieve adequate treatment response characterized by acr20
Description

ID.2

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
Description

ID.3

Data type

boolean

patients with rheumatoid autoimmune disease other than ra, including but not limited to sle(system lupus erythematosus), or significant systemic involvement secondary to ra.
Description

ID.4

Data type

boolean

patients who belong to the class iv of the acr classification criteria for functional status of ra. (acr amended criteria for the classification of functional capacity in rheumatoid arthritis; class iv: largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
Description

ID.5

Data type

boolean

patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
Description

ID.6

Data type

boolean

patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(tb),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis b, hepatitis c, or herpes zoster and etc. however, a patient with hand & foot fungal infections can participate.
Description

ID.7

Data type

boolean

Similar models

Eligibility Rheumatoid Arthritis NCT01347983

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
patients who had completed at least 5 out of the 7 visits scheduled for weeks 2, 4, 8, 12, 16, 20 and 24 in the tocilizumab phase iiib study(mra230tw).
boolean
ID.2
Item
patients assigned in the phase iiib study(mra230tw), who had received scheduled dose for at least 16 weeks but still failed to achieve adequate treatment response characterized by acr20
boolean
Item Group
C0680251 (UMLS CUI)
ID.3
Item
patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
boolean
ID.4
Item
patients with rheumatoid autoimmune disease other than ra, including but not limited to sle(system lupus erythematosus), or significant systemic involvement secondary to ra.
boolean
ID.5
Item
patients who belong to the class iv of the acr classification criteria for functional status of ra. (acr amended criteria for the classification of functional capacity in rheumatoid arthritis; class iv: largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
boolean
ID.6
Item
patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
boolean
ID.7
Item
patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(tb),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis b, hepatitis c, or herpes zoster and etc. however, a patient with hand & foot fungal infections can participate.
boolean

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