ID

31971

Beschrijving

Clinical Outcomes, Compliance and Effectiveness of Switching From Infliximab or Etanercept to Adalimumab in Patients With Active Rheumatoid Arthritis (RA). A Multicenter Post-Marketing Observational Study in Routine Clinical Use; ODM derived from: https://clinicaltrials.gov/show/NCT01083160

Link

https://clinicaltrials.gov/show/NCT01083160

Trefwoorden

Versies (1)
  1. 09-10-18 09-10-18 -
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See clinicaltrials.gov

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9 oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01083160

Engels

Eligibility Rheumatoid Arthritis NCT01083160

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients ≥18 and <75 years of age that meet the american college of rheumatology (acr) criteria for ra.
Beschrijving

Age | ACR Criteria Fulfill Rheumatoid Arthritis

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C3273747
UMLS CUI [2,2]
C1550543
UMLS CUI [2,3]
C0003873
patients with active ra defined as:
Beschrijving

Rheumatoid Arthritis

Datatype

boolean

Alias
UMLS CUI [1]
C0003873
1. ≥3 tender joints and ≥3 swollen joints, or
Beschrijving

Tender joint count | Swollen joint count

Datatype

boolean

Alias
UMLS CUI [1]
C0451530
UMLS CUI [2]
C0451521
2. das 28 score >3.1
Beschrijving

Disease activity score DAS28

Datatype

boolean

Alias
UMLS CUI [1]
C4481729
patients who are discontinuing treatment with either infliximab or etanercept due to:
Beschrijving

Infliximab Discontinued | Etanercept Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C0666743
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0717758
UMLS CUI [2,2]
C1444662
1. lack of efficacy, or
Beschrijving

Lack of Efficacy

Datatype

boolean

Alias
UMLS CUI [1]
C0235828
2. incomplete response.
Beschrijving

Response Incomplete

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0205257
patients that, in the opinion of the physician could result beneficiated with the locally approved treatment scheme of adalimumab
Beschrijving

adalimumab | Therapeutic procedure Patient benefit

Datatype

boolean

Alias
UMLS CUI [1]
C1122087
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C0814225
those patients who switch from infliximab or etanercept to adalimumab has been done in the last 60 days could be included in the study.
Beschrijving

Infliximab | Etanercept | Therapy change | Adalimumab

Datatype

boolean

Alias
UMLS CUI [1]
C0666743
UMLS CUI [2]
C0717758
UMLS CUI [3]
C3665894
UMLS CUI [4]
C1122087
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following patients will not be included in the study:
Beschrijving

Patients Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332196
patients who have active infections.
Beschrijving

Communicable Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
patients with latent tb. for this protocol, evidence of latent tb infection is defined as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement. any suggested data on the clinical history or chest x-ray.
Beschrijving

Latent Tuberculosis | Induration Thickness | Data Suggestive Medical History | Data Suggestive Chest X-ray

Datatype

boolean

Alias
UMLS CUI [1]
C1609538
UMLS CUI [2,1]
C0332534
UMLS CUI [2,2]
C1280412
UMLS CUI [3,1]
C1511726
UMLS CUI [3,2]
C0332299
UMLS CUI [3,3]
C0262926
UMLS CUI [4,1]
C1511726
UMLS CUI [4,2]
C0332299
UMLS CUI [4,3]
C0039985
patients participating into another study or clinical trial
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
any condition that according to the criteria of the participating physician represents an obstacle for study conduct and/or represents a potential unacceptable risk for patients.
Beschrijving

Condition Interferes with Completion of clinical trial | Condition Study Subject Participation Status At risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
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Similar models

Eligibility Rheumatoid Arthritis NCT01083160

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | ACR Criteria Fulfill Rheumatoid Arthritis
Item
patients ≥18 and <75 years of age that meet the american college of rheumatology (acr) criteria for ra.
boolean
C0001779 (UMLS CUI [1])
C3273747 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
C0003873 (UMLS CUI [2,3])
Rheumatoid Arthritis
Item
patients with active ra defined as:
boolean
C0003873 (UMLS CUI [1])
Tender joint count | Swollen joint count
Item
1. ≥3 tender joints and ≥3 swollen joints, or
boolean
C0451530 (UMLS CUI [1])
C0451521 (UMLS CUI [2])
Disease activity score DAS28
Item
2. das 28 score >3.1
boolean
C4481729 (UMLS CUI [1])
Infliximab Discontinued | Etanercept Discontinued
Item
patients who are discontinuing treatment with either infliximab or etanercept due to:
boolean
C0666743 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0717758 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Lack of Efficacy
Item
1. lack of efficacy, or
boolean
C0235828 (UMLS CUI [1])
Response Incomplete
Item
2. incomplete response.
boolean
C1704632 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
adalimumab | Therapeutic procedure Patient benefit
Item
patients that, in the opinion of the physician could result beneficiated with the locally approved treatment scheme of adalimumab
boolean
C1122087 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0814225 (UMLS CUI [2,3])
Infliximab | Etanercept | Therapy change | Adalimumab
Item
those patients who switch from infliximab or etanercept to adalimumab has been done in the last 60 days could be included in the study.
boolean
C0666743 (UMLS CUI [1])
C0717758 (UMLS CUI [2])
C3665894 (UMLS CUI [3])
C1122087 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Patients Excluded
Item
the following patients will not be included in the study:
boolean
C0030705 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Communicable Diseases
Item
patients who have active infections.
boolean
C0009450 (UMLS CUI [1])
Latent Tuberculosis | Induration Thickness | Data Suggestive Medical History | Data Suggestive Chest X-ray
Item
patients with latent tb. for this protocol, evidence of latent tb infection is defined as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement. any suggested data on the clinical history or chest x-ray.
boolean
C1609538 (UMLS CUI [1])
C0332534 (UMLS CUI [2,1])
C1280412 (UMLS CUI [2,2])
C1511726 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0262926 (UMLS CUI [3,3])
C1511726 (UMLS CUI [4,1])
C0332299 (UMLS CUI [4,2])
C0039985 (UMLS CUI [4,3])
Study Subject Participation Status
Item
patients participating into another study or clinical trial
boolean
C2348568 (UMLS CUI [1])
Condition Interferes with Completion of clinical trial | Condition Study Subject Participation Status At risk
Item
any condition that according to the criteria of the participating physician represents an obstacle for study conduct and/or represents a potential unacceptable risk for patients.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
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