ID

31858

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00780793

Trefwoorden

  1. 04-10-18 04-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 oktober 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00780793

Eligibility Rheumatoid Arthritis NCT00780793

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age | Rheumatoid Arthritis

Datatype

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;
Beschrijving

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

Datatype

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);
Beschrijving

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

Datatype

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
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with steroids;
Beschrijving

Steroid therapy

Datatype

boolean

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

Disease Progression X-ray

Datatype

boolean

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

Operative Surgical Procedures Planned

Datatype

boolean

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

Pregnancy

Datatype

boolean

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

Neoplastic disease

Datatype

boolean

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

Autoimmune Diseases | Exception Rheumatoid Arthritis

Datatype

boolean

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

Lacking Able to speak French language | Comprehension French language Unable

Datatype

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;
Beschrijving

Informed Consent Absent

Datatype

boolean

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

Medical insurance coverage Absent

Datatype

boolean

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

Similar models

Eligibility Rheumatoid Arthritis NCT00780793

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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