ID

31847

Description

A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00713544

Link

https://clinicaltrials.gov/show/NCT00713544

Keywords

Versions (1)
  1. 10/2/18 10/2/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 2, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00713544

English

Eligibility Rheumatoid Arthritis NCT00713544

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of ra with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (esr) or c-reactive protein (crp).
Description

Rheumatoid Arthritis | Swollen joint count | Tender joint count | Elevated erythrocyte sedimentation rate (ESR) Hematologic Test | Elevated C-reactive protein Hematologic Test

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0451521
UMLS CUI [3]
C0451530
UMLS CUI [4,1]
C1867037
UMLS CUI [4,2]
C0018941
UMLS CUI [5,1]
C0742906
UMLS CUI [5,2]
C0018941
at least one of the following: documented history of positive rheumatoid factor (blood test), current presence of positive rheumatoid factor (blood test), baseline radiographic erosion, presence of serum anti-cyclic citrullinated peptide antibodies (bloo
Description

Rheumatoid factor positive Hematologic Test | Bone erosion Radiographic | Anti-cyclic citrullinated peptide antibody Hematologic Test

Data type

boolean

Alias
UMLS CUI [1,1]
C0151379
UMLS CUI [1,2]
C0018941
UMLS CUI [2,1]
C0587240
UMLS CUI [2,2]
C0444708
UMLS CUI [3,1]
C2210597
UMLS CUI [3,2]
C0018941
be receiving either: oral (tablets) or subcutaneous (injection) methotrexate for at least 6 months prior to randomisation.
Description

Methotrexate Oral Tablet | Subcutaneous injection of methotrexate

Data type

boolean

Alias
UMLS CUI [1]
C1246896
UMLS CUI [2]
C2585798
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other inflammatory disease in addition to ra that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, etc).
Description

Inflammatory disorder In addition to Rheumatoid Arthritis | Interference Clinical Trial | Polymyalgia Rheumatica | Giant Cell Arteritis | Arthritis, Reactive

Data type

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0003873
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0008976
UMLS CUI [3]
C0032533
UMLS CUI [4]
C0039483
UMLS CUI [5]
C0085435
current chronic pain disorders including fibromyalgia and chronic fatigue syndromes.
Description

Chronic pain | Fibromyalgia | Chronic Fatigue Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0150055
UMLS CUI [2]
C0016053
UMLS CUI [3]
C0015674
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Similar models

Eligibility Rheumatoid Arthritis NCT00713544

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis | Swollen joint count | Tender joint count | Elevated erythrocyte sedimentation rate (ESR) Hematologic Test | Elevated C-reactive protein Hematologic Test
Item
diagnosis of ra with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (esr) or c-reactive protein (crp).
boolean
C0003873 (UMLS CUI [1])
C0451521 (UMLS CUI [2])
C0451530 (UMLS CUI [3])
C1867037 (UMLS CUI [4,1])
C0018941 (UMLS CUI [4,2])
C0742906 (UMLS CUI [5,1])
C0018941 (UMLS CUI [5,2])
Rheumatoid factor positive Hematologic Test | Bone erosion Radiographic | Anti-cyclic citrullinated peptide antibody Hematologic Test
Item
at least one of the following: documented history of positive rheumatoid factor (blood test), current presence of positive rheumatoid factor (blood test), baseline radiographic erosion, presence of serum anti-cyclic citrullinated peptide antibodies (bloo
boolean
C0151379 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0587240 (UMLS CUI [2,1])
C0444708 (UMLS CUI [2,2])
C2210597 (UMLS CUI [3,1])
C0018941 (UMLS CUI [3,2])
Methotrexate Oral Tablet | Subcutaneous injection of methotrexate
Item
be receiving either: oral (tablets) or subcutaneous (injection) methotrexate for at least 6 months prior to randomisation.
boolean
C1246896 (UMLS CUI [1])
C2585798 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Inflammatory disorder In addition to Rheumatoid Arthritis | Interference Clinical Trial | Polymyalgia Rheumatica | Giant Cell Arteritis | Arthritis, Reactive
Item
any other inflammatory disease in addition to ra that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, etc).
boolean
C1290884 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
C0521102 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0032533 (UMLS CUI [3])
C0039483 (UMLS CUI [4])
C0085435 (UMLS CUI [5])
Chronic pain | Fibromyalgia | Chronic Fatigue Syndrome
Item
current chronic pain disorders including fibromyalgia and chronic fatigue syndromes.
boolean
C0150055 (UMLS CUI [1])
C0016053 (UMLS CUI [2])
C0015674 (UMLS CUI [3])
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