ID

15982

Descrizione

Real Life Evaluation of Rheumatoid Arthritis Patients in Israel Treated With HUMIRA; ODM derived from: https://clinicaltrials.gov/show/NCT02322723

collegamento

https://clinicaltrials.gov/show/NCT02322723

Keywords

versioni (2)
  1. 21/06/16 21/06/16 -
  2. 24/06/16 24/06/16 - Julian Varghese
Caricato su

24 giugno 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Rheumatoid Arthritis NCT02322723

Inglese

Eligibility Rheumatoid Arthritis NCT02322723

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient is eligible to adalimumab treatment according to the israeli national health basket and for whom a decision of initiating adalimumab has already been taken. patients that are naïve to adalimumab therapy, that have been prescribed adalimumab in accordance to physician's clinical decision and according to local guidelines, up to 30 days prior to screening.
Descrizione

Therapeutic procedure adalimumab | Therapy naive adalimumab

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1122087
UMLS CUI [2,1]
C0919936
UMLS CUI [2,2]
C1122087
2. patient has performed tuberculosis (tb) screening and treatment according to national guidelines for tb screening prior to anti tumor necrosis factor (anti-tnf) treatment.
Descrizione

Tuberculosis screening | Tuberculosis treatment | Anti-tumor necrosis factor therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0420004
UMLS CUI [2]
C0749724
UMLS CUI [3]
C0281481
3. patient has been diagnosed with rheumatoid arthritis (ra) and has disease duration < 3 years.
Descrizione

Rheumatoid Arthritis | disease length

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
4. patient has moderately to severely active ra defined by disease activity score (das) (moderately (3.2 ≤ das ≤ 5.1) severely (das ≥5.1))
Descrizione

Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe | Disease activity score in rheumatoid arthritis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C2732410
5. patient is able to sign written informed consent.
Descrizione

Informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
6. patient is treated with methotrexate (mtx) alone or in combination with other disease modifying antirheumatic drugs (dmards)
Descrizione

Therapeutic procedure Methotrexate | Therapeutic procedure Methotrexate Combined Disease-Modifying Antirheumatic Drugs

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0025677
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0025677
UMLS CUI [2,3]
C0205195
UMLS CUI [2,4]
C0242708
7. patient might have been treated with another anti-tnf inhibitor agent if discontinued due to secondary loss of efficacy or side effects.
Descrizione

Drug therapy discontinued Due to Lack of Efficacy Secondary | Drug therapy discontinued Due to Adverse effects | Tumor necrosis factor alpha (TNF-) inhibitors Other

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0558681
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0235828
UMLS CUI [1,4]
C0175668
UMLS CUI [2,1]
C0558681
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0879626
UMLS CUI [3,1]
C3653350
UMLS CUI [3,2]
C0205394
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient with known hypersensitivity to adalimumab, or any of its components.
Descrizione

Hypersensitivity adalimumab | Hypersensitivity adalimumab Component

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1122087
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1122087
UMLS CUI [2,3]
C1705248
2. patients suffering from serious infection, latent tb or other conditions prohibiting the use of adalimumab.
Descrizione

Communicable Diseases Serious | Latent Tuberculosis | Condition Preventing adalimumab Use

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C1609538
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C1122087
UMLS CUI [3,4]
C1524063
3. patient had previous non-response to an anti-tnf agent.
Descrizione

Anti-tumor necrosis factor alpha drug Previous | Unresponsive to Treatment

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1562242
UMLS CUI [1,2]
C0205269
4. patients currently treated with other biologic therapy.
Descrizione

biological therap

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0205460
Ritorna all'inizio della pagina

Similar models

Eligibility Rheumatoid Arthritis NCT02322723

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Therapeutic procedure adalimumab | Therapy naive adalimumab
Item
1. patient is eligible to adalimumab treatment according to the israeli national health basket and for whom a decision of initiating adalimumab has already been taken. patients that are naïve to adalimumab therapy, that have been prescribed adalimumab in accordance to physician's clinical decision and according to local guidelines, up to 30 days prior to screening.
boolean
C0087111 (UMLS CUI [1,1])
C1122087 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2,1])
C1122087 (UMLS CUI [2,2])
Tuberculosis screening | Tuberculosis treatment | Anti-tumor necrosis factor therapy
Item
2. patient has performed tuberculosis (tb) screening and treatment according to national guidelines for tb screening prior to anti tumor necrosis factor (anti-tnf) treatment.
boolean
C0420004 (UMLS CUI [1])
C0749724 (UMLS CUI [2])
C0281481 (UMLS CUI [3])
Rheumatoid Arthritis | disease length
Item
3. patient has been diagnosed with rheumatoid arthritis (ra) and has disease duration < 3 years.
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe | Disease activity score in rheumatoid arthritis
Item
4. patient has moderately to severely active ra defined by disease activity score (das) (moderately (3.2 ≤ das ≤ 5.1) severely (das ≥5.1))
boolean
C0003873 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2732410 (UMLS CUI [3])
Informed consent
Item
5. patient is able to sign written informed consent.
boolean
C0021430 (UMLS CUI [1])
Therapeutic procedure Methotrexate | Therapeutic procedure Methotrexate Combined Disease-Modifying Antirheumatic Drugs
Item
6. patient is treated with methotrexate (mtx) alone or in combination with other disease modifying antirheumatic drugs (dmards)
boolean
C0087111 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
C0205195 (UMLS CUI [2,3])
C0242708 (UMLS CUI [2,4])
Drug therapy discontinued Due to Lack of Efficacy Secondary | Drug therapy discontinued Due to Adverse effects | Tumor necrosis factor alpha (TNF-) inhibitors Other
Item
7. patient might have been treated with another anti-tnf inhibitor agent if discontinued due to secondary loss of efficacy or side effects.
boolean
C0558681 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0235828 (UMLS CUI [1,3])
C0175668 (UMLS CUI [1,4])
C0558681 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0879626 (UMLS CUI [2,3])
C3653350 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity adalimumab | Hypersensitivity adalimumab Component
Item
1. patient with known hypersensitivity to adalimumab, or any of its components.
boolean
C0020517 (UMLS CUI [1,1])
C1122087 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1122087 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Communicable Diseases Serious | Latent Tuberculosis | Condition Preventing adalimumab Use
Item
2. patients suffering from serious infection, latent tb or other conditions prohibiting the use of adalimumab.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1609538 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C1122087 (UMLS CUI [3,3])
C1524063 (UMLS CUI [3,4])
Anti-tumor necrosis factor alpha drug Previous | Unresponsive to Treatment
Item
3. patient had previous non-response to an anti-tnf agent.
boolean
C1562242 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
biological therap
Item
4. patients currently treated with other biologic therapy.
boolean
C0205460 (UMLS CUI [1])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial