ID

31875

Beschreibung

A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT00845832

Link

https://clinicaltrials.gov/show/NCT00845832

Stichworte

Versionen (1)
  1. 05.10.18 05.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00845832

Englisch

Eligibility Rheumatoid Arthritis NCT00845832

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, 18-65 years of age;
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
rheumatoid arthritis, functional status i-iii;
Beschreibung

Rheumatoid Arthritis Functional Status Class

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
sjc>=4 (28 joint count) and tjc>=4 (28 joint count) at screening and baseline;
Beschreibung

Swollen 28 joint count | Tender 28 joint count

Datentyp

boolean

Alias
UMLS CUI [1]
C2711873
UMLS CUI [2]
C2711398
rf and/or anti-ccp positive;
Beschreibung

Rheumatoid factor positive | Anti-cyclic citrullinated peptide antibody positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0151379
UMLS CUI [2]
C2609056
may have failed up to 1 approved anti-tnf agent (infliximab, etanercept or adalimumab);
Beschreibung

Anti-tumor necrosis factor alpha drug Quantity failed | infliximab | Etanercept | adalimumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1562242
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [2]
C0666743
UMLS CUI [3]
C0717758
UMLS CUI [4]
C1122087
inadequate response to methotrexate, at a dose of 7.5-25mg weekly for at least 12 weeks, at a stable dose for past 4 weeks.
Beschreibung

Methotrexate Dose Stable U/week | Response Inadequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205412
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Inflammatory joint disease | Exception Rheumatoid Arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
diagnosis of juvenile idiopathic arthritis and/or rheumatoid arthritis before age 16;
Beschreibung

Juvenile arthritis | Juvenile rheumatoid arthritis | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C3495559
UMLS CUI [2]
C3714757
UMLS CUI [3]
C0001779
significant cardiac or pulmonary disease;
Beschreibung

Heart Disease | Lung disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0024115
previous treatment with any biologic agent for rheumatoid arthritis (other than infliximab, etanercept or adalimumab).
Beschreibung

Biological agent Rheumatoid Arthritis | Exception Infliximab | Exception Etanercept | Exception Adalimumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C0003873
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0666743
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0717758
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1122087
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00845832

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, 18-65 years of age;
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Rheumatoid Arthritis Functional Status Class
Item
rheumatoid arthritis, functional status i-iii;
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Swollen 28 joint count | Tender 28 joint count
Item
sjc>=4 (28 joint count) and tjc>=4 (28 joint count) at screening and baseline;
boolean
C2711873 (UMLS CUI [1])
C2711398 (UMLS CUI [2])
Rheumatoid factor positive | Anti-cyclic citrullinated peptide antibody positive
Item
rf and/or anti-ccp positive;
boolean
C0151379 (UMLS CUI [1])
C2609056 (UMLS CUI [2])
Anti-tumor necrosis factor alpha drug Quantity failed | infliximab | Etanercept | adalimumab
Item
may have failed up to 1 approved anti-tnf agent (infliximab, etanercept or adalimumab);
boolean
C1562242 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0666743 (UMLS CUI [2])
C0717758 (UMLS CUI [3])
C1122087 (UMLS CUI [4])
Methotrexate Dose Stable U/week | Response Inadequate
Item
inadequate response to methotrexate, at a dose of 7.5-25mg weekly for at least 12 weeks, at a stable dose for past 4 weeks.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
C1704632 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis | Rheumatoid arthritis with systemic involvement
Item
rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic involvement secondary to rheumatoid arthritis;
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
Item
history of, or current, inflammatory joint disease other than rheumatoid arthritis;
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Juvenile arthritis | Juvenile rheumatoid arthritis | Age
Item
diagnosis of juvenile idiopathic arthritis and/or rheumatoid arthritis before age 16;
boolean
C3495559 (UMLS CUI [1])
C3714757 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Heart Disease | Lung disease
Item
significant cardiac or pulmonary disease;
boolean
C0018799 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
Biological agent Rheumatoid Arthritis | Exception Infliximab | Exception Etanercept | Exception Adalimumab
Item
previous treatment with any biologic agent for rheumatoid arthritis (other than infliximab, etanercept or adalimumab).
boolean
C0005515 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0666743 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0717758 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1122087 (UMLS CUI [4,2])
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