ID

12555

Descrizione

A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT01480388

collegamento

https://clinicaltrials.gov/show/NCT01480388

Keywords

versioni (1)
  1. 30/11/15 30/11/15 -
Caricato su

30 novembre 2015

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Active Rheumatoid Arthritis; Rheumatoid Arthritis NCT01480388

Inglese

Eligibility Active Rheumatoid Arthritis; Rheumatoid Arthritis NCT01480388

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
has a diagnosis of rheumatoid arthritis (ra) for at least 6 months before screening.
Descrizione

diagnosis of rheumatoid arthritis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0003873
positive test for either anti-cyclic citrullinated peptide (anti-ccp) antibody or rheumatoid factor (rf) in serum at screening.
Descrizione

anti-cyclic citrullinated peptide (anti-ccp) antibody or rheumatoid factor (rf) in serum

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0035448
UMLS CUI [2]
C1138802
has active ra defined as persistent disease activity with the following criteria: at least 6 swollen and 6 tender joints, and serum crp ≥ 0.70 mg/dl at screening.
Descrizione

active ra defined as persistent disease activity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3871171
has been treated with and tolerated methotrexate (mtx) treatment at dosages of 10 to 25 mg/week for a minimum of 6 months prior to screening and must be on a stable dose for a minimum of 8 weeks prior to screening
Descrizione

has been treated with and tolerated methotrexate

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0025677
must be post-menopausal or if pre-menopausal, must use an acceptable form of birth control
Descrizione

Must be post-menopausal or use an acceptable form of birth control

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0700589
has completed at least 5 days of daily pain diary in the 10 days prior to randomization.
Descrizione

daily pain diary

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0451366
UMLS CUI [1,2]
C0332173
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
has inflammatory diseases other than ra, such as lupus.
Descrizione

Other inflammatory diseases such as lupus

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1290886
is currently receiving treatment for ra other than methotrexate, nsaids, or oral corticosteroids such as prednisone, or pain medicines.
Descrizione

is currently receiving treatment for ra other than methotrexate, nsaids, or oral corticosteroids such as prednisone, or pain medicines.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0003873
has ever received any biologic agent for a rheumatic indication.
Descrizione

has ever received any biologic agent for a rheumatic indication

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0005527
has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled.
Descrizione

Concurrent, severe and uncontrolled Comorbidity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009488
has moderate or severe renal insufficiency
Descrizione

renal insufficiency

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1565489
has a recent (within 2 months) serious infection
Descrizione

infection

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009450
has had an opportunistic infection.
Descrizione

opportunistic infection

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0029118
has had cancer within the past 5 years (except certain skin or cervical conditions)
Descrizione

has had cancer within the past 5 years

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
has abused substances or alcohol within the past 2 years
Descrizione

Substance use disorder

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038586
has active hepatitis b or c infection
Descrizione

hepatitis b or c infection

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0019163
has had active tuberculosis
Descrizione

has had active tuberculosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0151332
has had exposure to tuberculosis without preventative treatment
Descrizione

has had exposure to tuberculosis without preventative treatment

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0149796
UMLS CUI [2]
C0199176
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Similar models

Eligibility Active Rheumatoid Arthritis; Rheumatoid Arthritis NCT01480388

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
diagnosis of rheumatoid arthritis
Item
has a diagnosis of rheumatoid arthritis (ra) for at least 6 months before screening.
boolean
C0003873 (UMLS CUI [1])
anti-cyclic citrullinated peptide (anti-ccp) antibody or rheumatoid factor (rf) in serum
Item
positive test for either anti-cyclic citrullinated peptide (anti-ccp) antibody or rheumatoid factor (rf) in serum at screening.
boolean
C0035448 (UMLS CUI [1])
C1138802 (UMLS CUI [2])
active ra defined as persistent disease activity
Item
has active ra defined as persistent disease activity with the following criteria: at least 6 swollen and 6 tender joints, and serum crp ≥ 0.70 mg/dl at screening.
boolean
C3871171 (UMLS CUI [1])
has been treated with and tolerated methotrexate
Item
has been treated with and tolerated methotrexate (mtx) treatment at dosages of 10 to 25 mg/week for a minimum of 6 months prior to screening and must be on a stable dose for a minimum of 8 weeks prior to screening
boolean
C0025677 (UMLS CUI [1])
Must be post-menopausal or use an acceptable form of birth control
Item
must be post-menopausal or if pre-menopausal, must use an acceptable form of birth control
boolean
C0232970 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
daily pain diary
Item
has completed at least 5 days of daily pain diary in the 10 days prior to randomization.
boolean
C0451366 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Other inflammatory diseases such as lupus
Item
has inflammatory diseases other than ra, such as lupus.
boolean
C0009488 (UMLS CUI [1,1])
C1290886 (UMLS CUI [1,2])
is currently receiving treatment for ra other than methotrexate, nsaids, or oral corticosteroids such as prednisone, or pain medicines.
Item
is currently receiving treatment for ra other than methotrexate, nsaids, or oral corticosteroids such as prednisone, or pain medicines.
boolean
C2347852 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
has ever received any biologic agent for a rheumatic indication
Item
has ever received any biologic agent for a rheumatic indication.
boolean
C2347852 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
Concurrent, severe and uncontrolled Comorbidity
Item
has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled.
boolean
C0009488 (UMLS CUI [1])
renal insufficiency
Item
has moderate or severe renal insufficiency
boolean
C1565489 (UMLS CUI [1])
infection
Item
has a recent (within 2 months) serious infection
boolean
C0009450 (UMLS CUI [1])
opportunistic infection
Item
has had an opportunistic infection.
boolean
C0029118 (UMLS CUI [1])
has had cancer within the past 5 years
Item
has had cancer within the past 5 years (except certain skin or cervical conditions)
boolean
C0006826 (UMLS CUI [1])
Substance use disorder
Item
has abused substances or alcohol within the past 2 years
boolean
C0038586 (UMLS CUI [1])
hepatitis b or c infection
Item
has active hepatitis b or c infection
boolean
C0019196 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
has had active tuberculosis
Item
has had active tuberculosis
boolean
C0151332 (UMLS CUI [1])
has had exposure to tuberculosis without preventative treatment
Item
has had exposure to tuberculosis without preventative treatment
boolean
C0149796 (UMLS CUI [1])
C0199176 (UMLS CUI [2])
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