ID

25284

Description

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

Link

https://clinicaltrials.gov/show/NCT00963703

Keywords

  1. 8/30/17 8/30/17 -
Uploaded on

August 30, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00963703

Eligibility Rheumatoid Arthritis NCT00963703

Inclusion Criteria
Description

Inclusion Criteria

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

Rheumatoid Arthritis

Data type

boolean

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

disease length

Data type

boolean

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

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

Data type

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
Description

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

Data type

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
Description

Adrenal Cortex Hormones Dose Stable U/day

Data type

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
Description

Consent Arthroscopic synovial biopsy Quantity

Data type

boolean

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

Exclusion Criteria

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

Severe allergy Monoclonal Antibodies | Anaphylaxis Severe Monoclonal Antibodies

Data type

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
Description

rituximab

Data type

boolean

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

Arava

Data type

boolean

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

Injection of steroid

Data type

boolean

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

Investigational New Drugs

Data type

boolean

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

Medical condition Severe | Disease Severe | Communicable Disease Severe

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Similar models

Eligibility Rheumatoid Arthritis NCT00963703

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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