ID

25284

Descripción

Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00963703

Link

https://clinicaltrials.gov/show/NCT00963703

Palabras clave

Versiones (1)
  1. 30/8/17 30/8/17 -
Subido en

30 de agosto de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00963703

Inglés

Eligibility Rheumatoid Arthritis NCT00963703

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with documented rheumatoid arthritis by acr criteria
Descripción

Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003873
disease duration < 5 years
Descripción

disease length

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0872146
may have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single dmard or in combination
Descripción

Methotrexate | Hydroxychloroquine | Sulfasalazine | DMARD Single | Combined Modality Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0020336
UMLS CUI [3]
C0036078
UMLS CUI [4,1]
C0242708
UMLS CUI [4,2]
C0205171
UMLS CUI [5]
C0009429
tender joint count >= 6, swollen joint count >= 6, and one must be a knee
Descripción

Tender joint count | Swollen joint count | Involvement with Knee joint Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451530
UMLS CUI [2]
C0451521
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0022745
UMLS CUI [3,3]
C1265611
corticosteroids <= 10 mg per day permitted on stable doses for at least 4 weeks
Descripción

Adrenal Cortex Hormones Dose Stable U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
patients must consent to 2 arthroscopic synovial biopsy procedures
Descripción

Consent Arthroscopic synovial biopsy Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C0578443
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of severe allergic or anaphylactic reactions to monoclonal antibodies
Descripción

Severe allergy Monoclonal Antibodies | Anaphylaxis Severe Monoclonal Antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0003250
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0003250
previous treatment with rituximab
Descripción

rituximab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0393022
previous treatment with arava
Descripción

Arava

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0718644
injected with steroids within 4 weeks of day 1 of study
Descripción

Injection of steroid

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1261311
treatment with any investigational agent within 4 weeks of day of study
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
any severe or significant medical condition or disease or known active infection
Descripción

Medical condition Severe | Disease Severe | Communicable Disease Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205082
pregnancy or nursing at present
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Rheumatoid Arthritis NCT00963703

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
patients with documented rheumatoid arthritis by acr criteria
boolean
C0003873 (UMLS CUI [1])
disease length
Item
disease duration < 5 years
boolean
C0872146 (UMLS CUI [1])
Methotrexate | Hydroxychloroquine | Sulfasalazine | DMARD Single | Combined Modality Therapy
Item
may have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single dmard or in combination
boolean
C0025677 (UMLS CUI [1])
C0020336 (UMLS CUI [2])
C0036078 (UMLS CUI [3])
C0242708 (UMLS CUI [4,1])
C0205171 (UMLS CUI [4,2])
C0009429 (UMLS CUI [5])
Tender joint count | Swollen joint count | Involvement with Knee joint Quantity
Item
tender joint count >= 6, swollen joint count >= 6, and one must be a knee
boolean
C0451530 (UMLS CUI [1])
C0451521 (UMLS CUI [2])
C1314939 (UMLS CUI [3,1])
C0022745 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Adrenal Cortex Hormones Dose Stable U/day
Item
corticosteroids <= 10 mg per day permitted on stable doses for at least 4 weeks
boolean
C0001617 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Consent Arthroscopic synovial biopsy Quantity
Item
patients must consent to 2 arthroscopic synovial biopsy procedures
boolean
C1511481 (UMLS CUI [1,1])
C0578443 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Severe allergy Monoclonal Antibodies | Anaphylaxis Severe Monoclonal Antibodies
Item
history of severe allergic or anaphylactic reactions to monoclonal antibodies
boolean
C2945656 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0003250 (UMLS CUI [2,3])
rituximab
Item
previous treatment with rituximab
boolean
C0393022 (UMLS CUI [1])
Arava
Item
previous treatment with arava
boolean
C0718644 (UMLS CUI [1])
Injection of steroid
Item
injected with steroids within 4 weeks of day 1 of study
boolean
C1261311 (UMLS CUI [1])
Investigational New Drugs
Item
treatment with any investigational agent within 4 weeks of day of study
boolean
C0013230 (UMLS CUI [1])
Medical condition Severe | Disease Severe | Communicable Disease Severe
Item
any severe or significant medical condition or disease or known active infection
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnancy or nursing at present
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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