ID

41820

Description

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.; ODM derived from: https://clinicaltrials.gov/show/NCT01197534

Link

https://clinicaltrials.gov/show/NCT01197534

Keywords

Versions (3)
  1. 1/20/21 1/20/21 - Ahmed Rafee, MD
  2. 1/21/21 1/21/21 - Ahmed Rafee, MD
  3. 1/22/21 1/22/21 - Sarah Riepenhausen
Copyright Holder

AstraZeneca

Uploaded on

January 22, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01197534

English

Eligibility Rheumatoid Arthritis NCT01197534

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Active Rheumatoid Arthritis (RA) diagnosed after the age of 16?
Description

Active Rheumatoid Arthritis | Age at Diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C1828181
Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, Sulfasalazine, Hydroxychloroquine or Chloroquine?
Description

Methotrexat | Sulfasalazine | Hydroxychloroquine | Choloroquine

Data type

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0036078
UMLS CUI [3]
C0020336
UMLS CUI [4]
C0008269
4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count)and either erythrocyte sedimentation rate (esr) blood result of 28mm/h or more, or c-reactive protein (crp) blood result of 10mg/l or more?
Description

Joint Swelling; count | Joint Tenderness | Joint Pain | ESR | CRP

Data type

boolean

Alias
UMLS CUI [1,1]
C0152031
UMLS CUI [1,2]
C0449788
UMLS CUI [2,1]
C0240094
UMLS CUI [2,2]
C0449788
UMLS CUI [3,1]
C0003862
UMLS CUI [3,2]
C0449788
UMLS CUI [4]
C1176468
UMLS CUI [5]
C0201657
at least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)?
Description

History of Rheumatoid Factor | Current positive Rheumatoid Factor | Radiographic Bone Erosion | Anti-Cyclic Citrullinated Peptide Antibodies

Data type

boolean

Alias
UMLS CUI [1]
C0151379
UMLS CUI [2,1]
C0151379
UMLS CUI [2,2]
C0521116
UMLS CUI [3,1]
C0444708
UMLS CUI [3,2]
C0587240
UMLS CUI [4]
C2609056
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Pregnant or breastfeeding (applicable for females)?
Description

Pregnant | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Poorly controlled hypertension?
Description

Poorly controlled Hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C3853134
liver disease or significant liver function test abnormalities?
Description

Abnormal liver functions tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0023901
UMLS CUI [1,2]
C0205161
certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders?
Description

Inflammatory Disorder other than Rheumatoid Arthritis | Connective Tissue Disease | Chronic Pain Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1290884
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
UMLS CUI [3]
C0009782
UMLS CUI [4]
C1298685
recent or significant cardiovascular disease?
Description

Recent severe Cariovascular Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
significant active or recent infection including tuberculosis?
Description

Severe active infection | severe recent infection | Tuberculosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C2169571
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0041296
previous failure to respond to a tnf alpha antagonist, anakinra or previous treatment with other biological agent?
Description

Unresposive Therapy with TNF-Alpha Inhibitors | Unresponsive Therapy with Anakinra | Unresponsive Therapy with Biological Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C3537192
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0245109
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C0005515
UMLS CUI [3,2]
C0205269
severe renal impairment?
Description

Severe renal insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
neutropenia?
Description

Neutropenia

Data type

boolean

Alias
UMLS CUI [1]
C0027947
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Similar models

Eligibility Rheumatoid Arthritis NCT01197534

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Active Rheumatoid Arthritis | Age at Diagnosis
Item
Active Rheumatoid Arthritis (RA) diagnosed after the age of 16?
boolean
C0003873 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C1828181 (UMLS CUI [2,2])
Methotrexat | Sulfasalazine | Hydroxychloroquine | Choloroquine
Item
Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, Sulfasalazine, Hydroxychloroquine or Chloroquine?
boolean
C0025677 (UMLS CUI [1])
C0036078 (UMLS CUI [2])
C0020336 (UMLS CUI [3])
C0008269 (UMLS CUI [4])
Joint Swelling; count | Joint Tenderness | Joint Pain | ESR | CRP
Item
4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count)and either erythrocyte sedimentation rate (esr) blood result of 28mm/h or more, or c-reactive protein (crp) blood result of 10mg/l or more?
boolean
C0152031 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0240094 (UMLS CUI [2,1])
C0449788 (UMLS CUI [2,2])
C0003862 (UMLS CUI [3,1])
C0449788 (UMLS CUI [3,2])
C1176468 (UMLS CUI [4])
C0201657 (UMLS CUI [5])
History of Rheumatoid Factor | Current positive Rheumatoid Factor | Radiographic Bone Erosion | Anti-Cyclic Citrullinated Peptide Antibodies
Item
at least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)?
boolean
C0151379 (UMLS CUI [1])
C0151379 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0444708 (UMLS CUI [3,1])
C0587240 (UMLS CUI [3,2])
C2609056 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Pregnant | Breast Feeding
Item
Pregnant or breastfeeding (applicable for females)?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Poorly controlled Hypertension
Item
Poorly controlled hypertension?
boolean
C0020538 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Abnormal liver functions tests
Item
liver disease or significant liver function test abnormalities?
boolean
C0023901 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Inflammatory Disorder other than Rheumatoid Arthritis | Connective Tissue Disease | Chronic Pain Syndrome
Item
certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders?
boolean
C1290884 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0009782 (UMLS CUI [3])
C1298685 (UMLS CUI [4])
Recent severe Cariovascular Disease
Item
recent or significant cardiovascular disease?
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Severe active infection | severe recent infection | Tuberculosis
Item
significant active or recent infection including tuberculosis?
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C2169571 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0041296 (UMLS CUI [3])
Unresposive Therapy with TNF-Alpha Inhibitors | Unresponsive Therapy with Anakinra | Unresponsive Therapy with Biological Agents
Item
previous failure to respond to a tnf alpha antagonist, anakinra or previous treatment with other biological agent?
boolean
C3537192 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0245109 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0005515 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
Severe renal insufficiency
Item
severe renal impairment?
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Neutropenia
Item
neutropenia?
boolean
C0027947 (UMLS CUI [1])
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