ID

15982

Description

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

Link

https://clinicaltrials.gov/show/NCT02322723

Keywords

Versions (2)
  1. 6/21/16 6/21/16 -
  2. 6/24/16 6/24/16 - Julian Varghese
Uploaded on

June 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02322723

English

Eligibility Rheumatoid Arthritis NCT02322723

1 forms  
Inclusion Criteria
Description

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.
Description

Therapeutic procedure adalimumab | Therapy naive adalimumab

Data type

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.
Description

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

Data type

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.
Description

Rheumatoid Arthritis | disease length

Data type

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))
Description

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

Data type

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.
Description

Informed consent

Data type

boolean

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

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

Data type

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.
Description

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

Data type

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
Description

Exclusion Criteria

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

Hypersensitivity adalimumab | Hypersensitivity adalimumab Component

Data type

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.
Description

Communicable Diseases Serious | Latent Tuberculosis | Condition Preventing adalimumab Use

Data type

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.
Description

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

Data type

boolean

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

biological therap

Data type

boolean

Alias
UMLS CUI [1]
C0205460
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Similar models

Eligibility Rheumatoid Arthritis NCT02322723

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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