ID

17189

Descripción

An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00264550

Link

https://clinicaltrials.gov/show/NCT00264550

Palabras clave

Versiones (1)
  1. 30/8/16 30/8/16 -
Subido en

30 de agosto de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00264550

Inglés

Eligibility Rheumatoid Arthritis NCT00264550

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a diagnosis of rheumatoid arthritis (ra) (according to the revised 1987 criteria of the acr) for at least 3 months prior to screening
Descripción

Rheumatoid arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003873
must have been treated with and tolerated methotrexate (mtx) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a mtx dose of >=15 mg/week and <=25 mg/week and stable for at least 4 weeks prior to screening
Descripción

methotrexate dosage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
have active ra as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a)c-reactive protein (crp) >=1.5 mg/dl at screening or erythrocyte sedimentation rate (esr) by westergren method of >= 28 mm in the first hour at screening or baseline, b)morning stiffness of >= 30 minutes at screening and baseline, c)bone erosion by x-ray and/or magnetic resonance imaging (mri) prior to first administration of study agent, d)anti-cyclic citrullinated peptide (anti-ccp) antibody-positive or rheumatoid factor (rf) positive at screening
Descripción

swollen joint count, tender joint count; CRP, Westergren sedimentation rate; morning stiffness; bone erosion; anti-cyclic citrullinated peptide antibody-positive or rheumatoid factor positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2]
C0451530
UMLS CUI [3]
C0201657
UMLS CUI [4]
C0200705
UMLS CUI [5]
C0457086
UMLS CUI [6]
C0587240
UMLS CUI [7]
C2210597
UMLS CUI [8]
C0201660
if using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent
Descripción

if using oral corticosteroids, must be on a stable dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0205360
are considered eligible according to specified tuberculosis (tb) screening criteria
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
have inflammatory diseases other than ra that might confound the evaluation of the benefit of golimumab therapy
Descripción

other inflammatory diseases that might confound the evaluation of the benefit of golimumab therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C2353893
have had treatment with disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives other than mtx, during the 4 weeks prior to the first administration of study agent
Descripción

disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2]
C0021081
have had prior treatment with biologic anti-tumor necrosis factor (tnf) drugs (infliximab, etanercept, adalimumab)
Descripción

treatment with biologic anti-tumor necrosis factor (tnf) drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281481
have had history of, or ongoing, chronic or recurrent infectious disease.
Descripción

chronic or recurrent infectious disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0239998
have serious infection within 2 months prior to first administration of study agent
Descripción

Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
have a history of latent or active granulomatous infection, including tb, histoplasmosis, or coccidioidomycosis, prior to screening
Descripción

granulomatous infection, including tb, histoplasmosis, or coccidioidomycosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1610637
UMLS CUI [2]
C0041296
UMLS CUI [3]
C0019655
UMLS CUI [4]
C0009186
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Similar models

Eligibility Rheumatoid Arthritis NCT00264550

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid arthritis
Item
have a diagnosis of rheumatoid arthritis (ra) (according to the revised 1987 criteria of the acr) for at least 3 months prior to screening
boolean
C0003873 (UMLS CUI [1])
methotrexate dosage
Item
must have been treated with and tolerated methotrexate (mtx) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a mtx dose of >=15 mg/week and <=25 mg/week and stable for at least 4 weeks prior to screening
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
swollen joint count, tender joint count; CRP, Westergren sedimentation rate; morning stiffness; bone erosion; anti-cyclic citrullinated peptide antibody-positive or rheumatoid factor positive
Item
have active ra as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a)c-reactive protein (crp) >=1.5 mg/dl at screening or erythrocyte sedimentation rate (esr) by westergren method of >= 28 mm in the first hour at screening or baseline, b)morning stiffness of >= 30 minutes at screening and baseline, c)bone erosion by x-ray and/or magnetic resonance imaging (mri) prior to first administration of study agent, d)anti-cyclic citrullinated peptide (anti-ccp) antibody-positive or rheumatoid factor (rf) positive at screening
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
C0201657 (UMLS CUI [3])
C0200705 (UMLS CUI [4])
C0457086 (UMLS CUI [5])
C0587240 (UMLS CUI [6])
C2210597 (UMLS CUI [7])
C0201660 (UMLS CUI [8])
if using oral corticosteroids, must be on a stable dose
Item
if using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent
boolean
C0038317 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Study Subject Participation Status
Item
are considered eligible according to specified tuberculosis (tb) screening criteria
boolean
C2348568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
other inflammatory diseases that might confound the evaluation of the benefit of golimumab therapy
Item
have inflammatory diseases other than ra that might confound the evaluation of the benefit of golimumab therapy
boolean
C1290884 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C2353893 (UMLS CUI [1,3])
disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives
Item
have had treatment with disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives other than mtx, during the 4 weeks prior to the first administration of study agent
boolean
C0242708 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
treatment with biologic anti-tumor necrosis factor (tnf) drugs
Item
have had prior treatment with biologic anti-tumor necrosis factor (tnf) drugs (infliximab, etanercept, adalimumab)
boolean
C0281481 (UMLS CUI [1])
chronic or recurrent infectious disease
Item
have had history of, or ongoing, chronic or recurrent infectious disease.
boolean
C0151317 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
Infection
Item
have serious infection within 2 months prior to first administration of study agent
boolean
C0009450 (UMLS CUI [1])
granulomatous infection, including tb, histoplasmosis, or coccidioidomycosis
Item
have a history of latent or active granulomatous infection, including tb, histoplasmosis, or coccidioidomycosis, prior to screening
boolean
C1610637 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
C0019655 (UMLS CUI [3])
C0009186 (UMLS CUI [4])
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