ID

12555

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01480388

Trefwoorden

Versies (1)
  1. 30-11-15 30-11-15 -
Geüploaded op

30 november 2015

DOI

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Licentie

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

Engels

Eligibility Active Rheumatoid Arthritis; Rheumatoid Arthritis NCT01480388

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

diagnosis of rheumatoid arthritis

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

active ra defined as persistent disease activity

Datatype

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
Beschrijving

has been treated with and tolerated methotrexate

Datatype

boolean

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

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

Datatype

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.
Beschrijving

daily pain diary

Datatype

boolean

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

Exclusion Criteria

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

Other inflammatory diseases such as lupus

Datatype

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.
Beschrijving

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

Datatype

boolean

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

has ever received any biologic agent for a rheumatic indication

Datatype

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.
Beschrijving

Concurrent, severe and uncontrolled Comorbidity

Datatype

boolean

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

renal insufficiency

Datatype

boolean

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

infection

Datatype

boolean

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

opportunistic infection

Datatype

boolean

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

has had cancer within the past 5 years

Datatype

boolean

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

Substance use disorder

Datatype

boolean

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

hepatitis b or c infection

Datatype

boolean

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

has had active tuberculosis

Datatype

boolean

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

has had exposure to tuberculosis without preventative treatment

Datatype

boolean

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

Eligibility Active Rheumatoid Arthritis; Rheumatoid Arthritis NCT01480388

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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