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ID
15957
Beschreibung
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
Stichworte
Versionen (2)
- 21.06.16 21.06.16 -
- 24.06.16 24.06.16 - Julian Varghese
Hochgeladen am
21. Juni 2016
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Eligibility Rheumatoid Arthritis NCT02322723
Eligibility Rheumatoid Arthritis NCT02322723
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Rheumatoid Arthritis NCT02322723
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
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])
C0872146 (UMLS CUI [2])
C0872146 (UMLS CUI [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])
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])
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])
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])
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])
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])
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])
C0205156 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2])
C0205156 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2])
Therapeutic procedure biological Other
Item
4. patients currently treated with other biologic therapy.
boolean
C0087111 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205460 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])