ID

41820

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01197534

Nyckelord

  1. 2021-01-20 2021-01-20 - Ahmed Rafee, MD
  2. 2021-01-21 2021-01-21 - Ahmed Rafee, MD
  3. 2021-01-22 2021-01-22 - Sarah Riepenhausen
Rättsinnehavare

AstraZeneca

Uppladdad den

22 januari 2021

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT01197534

Eligibility Rheumatoid Arthritis NCT01197534

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Active Rheumatoid Arthritis | Age at Diagnosis

Datatyp

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?
Beskrivning

Methotrexat | Sulfasalazine | Hydroxychloroquine | Choloroquine

Datatyp

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?
Beskrivning

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

Datatyp

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)?
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

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

Pregnant | Breast Feeding

Datatyp

boolean

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

Poorly controlled Hypertension

Datatyp

boolean

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

Abnormal liver functions tests

Datatyp

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?
Beskrivning

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

Datatyp

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?
Beskrivning

Recent severe Cariovascular Disease

Datatyp

boolean

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

Severe active infection | severe recent infection | Tuberculosis

Datatyp

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?
Beskrivning

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

Datatyp

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?
Beskrivning

Severe renal insufficiency

Datatyp

boolean

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

Neutropenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0027947

Similar models

Eligibility Rheumatoid Arthritis NCT01197534

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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