ID

31858

Description

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

Link

https://clinicaltrials.gov/show/NCT00780793

Keywords

Versions (1)
  1. 10/4/18 10/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Rheumatoid Arthritis NCT00780793

English

Eligibility Rheumatoid Arthritis NCT00780793

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age | Rheumatoid Arthritis

Data type

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;
Description

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

Data type

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);
Description

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

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with steroids;
Description

Steroid therapy

Data type

boolean

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

Disease Progression X-ray

Data type

boolean

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

Operative Surgical Procedures Planned

Data type

boolean

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

Pregnancy

Data type

boolean

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

Neoplastic disease

Data type

boolean

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

Autoimmune Diseases | Exception Rheumatoid Arthritis

Data type

boolean

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

Lacking Able to speak French language | Comprehension French language Unable

Data type

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;
Description

Informed Consent Absent

Data type

boolean

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

Medical insurance coverage Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2136534
UMLS CUI [1,2]
C0332197
Back to the top of the page

Similar models

Eligibility Rheumatoid Arthritis NCT00780793

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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