ID

31993

Beschrijving

PoC in Rheumatoid Arthritis With Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT00605735

Link

https://clinicaltrials.gov/show/NCT00605735

Trefwoorden

Versies (1)
  1. 10-10-18 10-10-18 -
Houder van rechten

See clinicaltrials.gov

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10 oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis, NOS NCT00605735

Engels

Eligibility Rheumatoid Arthritis, NOS NCT00605735

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have a diagnosis of ra for at least 6 months
Beschrijving

Rheumatoid Arthritis Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
must be taking methotrexate for at least 3 months & on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
Beschrijving

Methotrexate Dose Stable U/week

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
must have at least 6 swollen and at least 8 tender joints
Beschrijving

Swollen joint count | Tender joint count

Datatype

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2]
C0451530
crp above upper limit of normal or esr > 28 mm/hr
Beschrijving

Elevated C-reactive protein | Erythrocyte sedimentation rate measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0742906
UMLS CUI [2]
C1176468
must wash-out (stop taking) other immunosuppressant medications to treat ra (except for methotrexate) before dosing with study medication
Beschrijving

Immunosuppressive Agents With Washout Period | Exception Methotrexate | Therapeutic procedure Rheumatoid Arthritis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C1710661
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025677
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0003873
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any infection including tb, hiv, hepatitis b or c
Beschrijving

Communicable Disease | Tuberculosis | HIV Infection | Hepatitis B | Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0041296
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0019196
recent infection requiring antibiotics within 4 weeks
Beschrijving

Communicable Disease Requirement Antibiotics

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
history of gastrointestinal disease (such as gerd, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
Beschrijving

Gastrointestinal Disease Treatment required for | Gastrointestinal Disease Requirement Operative Surgical Procedures | Gastroesophageal reflux disease | Gastrointestinal ulcer | Heartburn

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0543467
UMLS CUI [3]
C0017168
UMLS CUI [4]
C0237938
UMLS CUI [5]
C0018834
chronic use of proton pump inhibitors (such as losec, prilosec, prevacid, nexium), h2 blockers (such as tagamet, pepcid, zantac, axid) or antacids (such as mylanta, maalox)
Beschrijving

Proton Pump Inhibitors chronic | Losec | Prilosec | Prevacid | Nexium | H2 Antagonists chronic | Tagamet | Pepcid | Zantac | Axid | Antacids chronic | Mylanta | Maalox

Datatype

boolean

Alias
UMLS CUI [1,1]
C0358591
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0591742
UMLS CUI [3]
C0700777
UMLS CUI [4]
C0286036
UMLS CUI [5]
C0939400
UMLS CUI [6,1]
C0019593
UMLS CUI [6,2]
C0205191
UMLS CUI [7]
C0592157
UMLS CUI [8]
C0678119
UMLS CUI [9]
C0592278
UMLS CUI [10]
C0678129
UMLS CUI [11,1]
C0003138
UMLS CUI [11,2]
C0205191
UMLS CUI [12]
C0067044
UMLS CUI [13]
C0065461
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Similar models

Eligibility Rheumatoid Arthritis, NOS NCT00605735

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis Disease length
Item
must have a diagnosis of ra for at least 6 months
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Methotrexate Dose Stable U/week
Item
must be taking methotrexate for at least 3 months & on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Swollen joint count | Tender joint count
Item
must have at least 6 swollen and at least 8 tender joints
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
Elevated C-reactive protein | Erythrocyte sedimentation rate measurement
Item
crp above upper limit of normal or esr > 28 mm/hr
boolean
C0742906 (UMLS CUI [1])
C1176468 (UMLS CUI [2])
Immunosuppressive Agents With Washout Period | Exception Methotrexate | Therapeutic procedure Rheumatoid Arthritis
Item
must wash-out (stop taking) other immunosuppressant medications to treat ra (except for methotrexate) before dosing with study medication
boolean
C0021081 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C1710661 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease | Tuberculosis | HIV Infection | Hepatitis B | Hepatitis C
Item
any infection including tb, hiv, hepatitis b or c
boolean
C0009450 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
Communicable Disease Requirement Antibiotics
Item
recent infection requiring antibiotics within 4 weeks
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
Gastrointestinal Disease Treatment required for | Gastrointestinal Disease Requirement Operative Surgical Procedures | Gastroesophageal reflux disease | Gastrointestinal ulcer | Heartburn
Item
history of gastrointestinal disease (such as gerd, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
boolean
C0017178 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0017168 (UMLS CUI [3])
C0237938 (UMLS CUI [4])
C0018834 (UMLS CUI [5])
Proton Pump Inhibitors chronic | Losec | Prilosec | Prevacid | Nexium | H2 Antagonists chronic | Tagamet | Pepcid | Zantac | Axid | Antacids chronic | Mylanta | Maalox
Item
chronic use of proton pump inhibitors (such as losec, prilosec, prevacid, nexium), h2 blockers (such as tagamet, pepcid, zantac, axid) or antacids (such as mylanta, maalox)
boolean
C0358591 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0591742 (UMLS CUI [2])
C0700777 (UMLS CUI [3])
C0286036 (UMLS CUI [4])
C0939400 (UMLS CUI [5])
C0019593 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
C0592157 (UMLS CUI [7])
C0678119 (UMLS CUI [8])
C0592278 (UMLS CUI [9])
C0678129 (UMLS CUI [10])
C0003138 (UMLS CUI [11,1])
C0205191 (UMLS CUI [11,2])
C0067044 (UMLS CUI [12])
C0065461 (UMLS CUI [13])
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