ID

31858

Descrição

Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study; ODM derived from: https://clinicaltrials.gov/show/NCT00780793

Link

https://clinicaltrials.gov/show/NCT00780793

Palavras-chave

Versões (1)
  1. 04/10/2018 04/10/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de outubro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00780793

Inglês

Eligibility Rheumatoid Arthritis NCT00780793

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged 18 or more, diagnosed with ra according to the 1987 acr classification criteria;
Descrição

Age | Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0003873
ra treated with subcutaneous tnf-blockers (étanercept or adalimumab) at stable and standard dosage for 1 year or more, as monotherapy or associated with stable conventional dmard;
Descrição

Therapeutic procedure Rheumatoid Arthritis | Tumor Necrosis Factor Blocker Subcutaneous Dose Stable | Etanercept | adalimumab | Antirheumatic Drugs, Disease-Modifying | Combined Modality Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003873
UMLS CUI [2,1]
C2343929
UMLS CUI [2,2]
C1522438
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [3]
C0717758
UMLS CUI [4]
C1122087
UMLS CUI [5]
C0242708
UMLS CUI [6]
C0009429
ra in clinical remission, defined as a stable das28 ≤ 2.6 for 6 months or more, without any structural damage progression on x-rays (local reading by the treating rheumatologist);
Descrição

Rheumatoid Arthritis Remission | Disease activity score das28 Stable | Absence Disease Progression structural X-ray

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0544452
UMLS CUI [2,1]
C4481729
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0242656
UMLS CUI [3,3]
C0678594
UMLS CUI [3,4]
C0034571
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with steroids;
Descrição

Steroid therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149783
progressing disease on x-rays during the year preceding the trial;
Descrição

Disease Progression X-ray

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0034571
surgery planed in the 18 coming months;
Descrição

Operative Surgical Procedures Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
pregnancy;
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
on-going neoplastic disease;
Descrição

Neoplastic disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1882062
other auto-immune disorders different from ra;
Descrição

Autoimmune Diseases | Exception Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
inability to speak or understand french;
Descrição

Lacking Able to speak French language | Comprehension French language Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376246
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376246
UMLS CUI [2,3]
C1299582
absence of signed informed consent;
Descrição

Informed Consent Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332197
absence of medical insurance coverage.
Descrição

Medical insurance coverage Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2136534
UMLS CUI [1,2]
C0332197
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Similar models

Eligibility Rheumatoid Arthritis NCT00780793

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Rheumatoid Arthritis
Item
patients aged 18 or more, diagnosed with ra according to the 1987 acr classification criteria;
boolean
C0001779 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
Therapeutic procedure Rheumatoid Arthritis | Tumor Necrosis Factor Blocker Subcutaneous Dose Stable | Etanercept | adalimumab | Antirheumatic Drugs, Disease-Modifying | Combined Modality Therapy
Item
ra treated with subcutaneous tnf-blockers (étanercept or adalimumab) at stable and standard dosage for 1 year or more, as monotherapy or associated with stable conventional dmard;
boolean
C0087111 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C2343929 (UMLS CUI [2,1])
C1522438 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C0717758 (UMLS CUI [3])
C1122087 (UMLS CUI [4])
C0242708 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
Rheumatoid Arthritis Remission | Disease activity score das28 Stable | Absence Disease Progression structural X-ray
Item
ra in clinical remission, defined as a stable das28 ≤ 2.6 for 6 months or more, without any structural damage progression on x-rays (local reading by the treating rheumatologist);
boolean
C0003873 (UMLS CUI [1,1])
C0544452 (UMLS CUI [1,2])
C4481729 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0242656 (UMLS CUI [3,2])
C0678594 (UMLS CUI [3,3])
C0034571 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Steroid therapy
Item
treatment with steroids;
boolean
C0149783 (UMLS CUI [1])
Disease Progression X-ray
Item
progressing disease on x-rays during the year preceding the trial;
boolean
C0242656 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Operative Surgical Procedures Planned
Item
surgery planed in the 18 coming months;
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
Neoplastic disease
Item
on-going neoplastic disease;
boolean
C1882062 (UMLS CUI [1])
Autoimmune Diseases | Exception Rheumatoid Arthritis
Item
other auto-immune disorders different from ra;
boolean
C0004364 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Lacking Able to speak French language | Comprehension French language Unable
Item
inability to speak or understand french;
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376246 (UMLS CUI [1,3])
C0233733 (UMLS CUI [2,1])
C0376246 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Informed Consent Absent
Item
absence of signed informed consent;
boolean
C0021430 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Medical insurance coverage Absent
Item
absence of medical insurance coverage.
boolean
C2136534 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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