ID

31971

Beschreibung

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

Stichworte

Versionen (1)
  1. 09.10.18 09.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Oktober 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Rheumatoid Arthritis NCT01083160

Englisch

Eligibility Rheumatoid Arthritis NCT01083160

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age | ACR Criteria Fulfill Rheumatoid Arthritis

Datentyp

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:
Beschreibung

Rheumatoid Arthritis

Datentyp

boolean

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

Tender joint count | Swollen joint count

Datentyp

boolean

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

Disease activity score DAS28

Datentyp

boolean

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

Infliximab Discontinued | Etanercept Discontinued

Datentyp

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
Beschreibung

Lack of Efficacy

Datentyp

boolean

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

Response Incomplete

Datentyp

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
Beschreibung

adalimumab | Therapeutic procedure Patient benefit

Datentyp

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.
Beschreibung

Infliximab | Etanercept | Therapy change | Adalimumab

Datentyp

boolean

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

Exclusion Criteria

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

Patients Excluded

Datentyp

boolean

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

Communicable Diseases

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Study Subject Participation Status

Datentyp

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.
Beschreibung

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

Datentyp

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
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT01083160

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video