ID

31958

Description

Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01078155

Link

https://clinicaltrials.gov/show/NCT01078155

Keywords

Versions (1)
  1. 10/9/18 10/9/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 9, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01078155

English

Eligibility Rheumatoid Arthritis NCT01078155

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with active early and long-standing ra according to american college of rheumatology (acr) 1987 revised criteria.
Description

Early Rheumatoid Arthritis Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C3899278
UMLS CUI [1,2]
C0443252
patients with high disease activity das28 ≥ 5.1 according to the czech rheumatological society criteria.
Description

Rheumatoid arthritis disease activity high DAS28

Data type

boolean

Alias
UMLS CUI [1,1]
C2368568
UMLS CUI [1,2]
C4481729
patients must fulfill national guidelines for use of anti-tnf: inadequate clinical response to at least one disease-modifying antirheumatic drug (dmard; methotrexate, sulphasalazine, leflunomide, hydroxychloroquine, or combinations) and oral glucocorticoids (equivalent to ≥ 5 mg prednisolone per day), (for romania except glucocorticoids); chest x-ray, purified protein derivative (ppd)-skin test, quantiferon/tuberculosis (tb) gold test (if available) negative for tb.
Description

Guidelines Fulfill Use of Anti-TNF drug | DMARDs Quantity Response Inadequate | DMARDs | Methotrexate | Sulfasalazine | leflunomide | Hydroxychloroquine | Combined Modality Therapy | Glucocorticoids Oral | Equivalent Prednisolone U/day | Tuberculosis test negative Chest X-ray | PPD skin test negative | QuantiFERON-TB test without active tuberculosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0162791
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C1562242
UMLS CUI [2,1]
C0242708
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1704632
UMLS CUI [2,4]
C0205412
UMLS CUI [3]
C0242708
UMLS CUI [4]
C0025677
UMLS CUI [5]
C0036078
UMLS CUI [6]
C0063041
UMLS CUI [7]
C0020336
UMLS CUI [8]
C0009429
UMLS CUI [9,1]
C0017710
UMLS CUI [9,2]
C1527415
UMLS CUI [10,1]
C0205163
UMLS CUI [10,2]
C0032950
UMLS CUI [10,3]
C0456683
UMLS CUI [11,1]
C2242735
UMLS CUI [11,2]
C0039985
UMLS CUI [12]
C1328483
UMLS CUI [13]
C3161222
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have had a history of tnf blocking or rituximab therapy.
Description

Tumor necrosis factor alpha inhibitor | rituximab

Data type

boolean

Alias
UMLS CUI [1]
C4521709
UMLS CUI [2]
C0393022
patients who are being treated or will be treated with drug at risk of interaction with adalimumab (humira).
Description

Pharmaceutical Preparations At risk Interaction Adalimumab | Pharmaceutical Preparations At risk Interaction Humira

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0687133
UMLS CUI [1,4]
C1122087
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0687133
UMLS CUI [2,4]
C1171255
pregnant females and/or females without adequate method of contraception.
Description

Pregnancy | Gender Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
patients who didn't receive prior dmard therapy.
Description

DMARD Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0332197
patients participating in another study or clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
patients with severe osteoporosis (t-score [number that indicates whether or not bone loss has occurred] of ≤ -2.5 and/or prior vertebral fracture/s).
Description

Severe osteoporosis | T score Bone Density | Vertebral Fractures

Data type

boolean

Alias
UMLS CUI [1]
C1859443
UMLS CUI [2,1]
C3854607
UMLS CUI [2,2]
C0005938
UMLS CUI [3]
C0080179
patients with a history of total hip replacement of both extremities.
Description

Total Hip Replacement Extremities Both

Data type

boolean

Alias
UMLS CUI [1,1]
C0040508
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C1706086
patients who currently receive and/or received bone metabolism modulating agents including selective estrogen receptor modulators (serms), bisphosphonates, parathyroid hormone or anti-receptor activator of nuclear factor-kappab ligand (rankl) therapy.
Description

Pharmaceutical Preparations Modulating Bone metabolism | Selective Estrogen Receptor Modulators | Diphosphonates | Parathyroid Hormone | RANK Ligand Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0443264
UMLS CUI [1,3]
C0596204
UMLS CUI [2]
C0732611
UMLS CUI [3]
C0012544
UMLS CUI [4]
C0030520
UMLS CUI [5]
C3665044
subjects who are not eligible for tnf-blocking therapy according to the czech national registry (attra).
Description

Patients Ineligible TNF alpha inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C4521709
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Similar models

Eligibility Rheumatoid Arthritis NCT01078155

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Early Rheumatoid Arthritis Long-term
Item
patients with active early and long-standing ra according to american college of rheumatology (acr) 1987 revised criteria.
boolean
C3899278 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
Rheumatoid arthritis disease activity high DAS28
Item
patients with high disease activity das28 ≥ 5.1 according to the czech rheumatological society criteria.
boolean
C2368568 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
Guidelines Fulfill Use of Anti-TNF drug | DMARDs Quantity Response Inadequate | DMARDs | Methotrexate | Sulfasalazine | leflunomide | Hydroxychloroquine | Combined Modality Therapy | Glucocorticoids Oral | Equivalent Prednisolone U/day | Tuberculosis test negative Chest X-ray | PPD skin test negative | QuantiFERON-TB test without active tuberculosis
Item
patients must fulfill national guidelines for use of anti-tnf: inadequate clinical response to at least one disease-modifying antirheumatic drug (dmard; methotrexate, sulphasalazine, leflunomide, hydroxychloroquine, or combinations) and oral glucocorticoids (equivalent to ≥ 5 mg prednisolone per day), (for romania except glucocorticoids); chest x-ray, purified protein derivative (ppd)-skin test, quantiferon/tuberculosis (tb) gold test (if available) negative for tb.
boolean
C0162791 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C1562242 (UMLS CUI [1,4])
C0242708 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1704632 (UMLS CUI [2,3])
C0205412 (UMLS CUI [2,4])
C0242708 (UMLS CUI [3])
C0025677 (UMLS CUI [4])
C0036078 (UMLS CUI [5])
C0063041 (UMLS CUI [6])
C0020336 (UMLS CUI [7])
C0009429 (UMLS CUI [8])
C0017710 (UMLS CUI [9,1])
C1527415 (UMLS CUI [9,2])
C0205163 (UMLS CUI [10,1])
C0032950 (UMLS CUI [10,2])
C0456683 (UMLS CUI [10,3])
C2242735 (UMLS CUI [11,1])
C0039985 (UMLS CUI [11,2])
C1328483 (UMLS CUI [12])
C3161222 (UMLS CUI [13])
Item Group
C0680251 (UMLS CUI)
Tumor necrosis factor alpha inhibitor | rituximab
Item
patients who have had a history of tnf blocking or rituximab therapy.
boolean
C4521709 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
Pharmaceutical Preparations At risk Interaction Adalimumab | Pharmaceutical Preparations At risk Interaction Humira
Item
patients who are being treated or will be treated with drug at risk of interaction with adalimumab (humira).
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0687133 (UMLS CUI [1,3])
C1122087 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0687133 (UMLS CUI [2,3])
C1171255 (UMLS CUI [2,4])
Pregnancy | Gender Contraceptive methods Absent
Item
pregnant females and/or females without adequate method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
DMARD Absent
Item
patients who didn't receive prior dmard therapy.
boolean
C0242708 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patients participating in another study or clinical trial.
boolean
C2348568 (UMLS CUI [1])
Severe osteoporosis | T score Bone Density | Vertebral Fractures
Item
patients with severe osteoporosis (t-score [number that indicates whether or not bone loss has occurred] of ≤ -2.5 and/or prior vertebral fracture/s).
boolean
C1859443 (UMLS CUI [1])
C3854607 (UMLS CUI [2,1])
C0005938 (UMLS CUI [2,2])
C0080179 (UMLS CUI [3])
Total Hip Replacement Extremities Both
Item
patients with a history of total hip replacement of both extremities.
boolean
C0040508 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1706086 (UMLS CUI [1,3])
Pharmaceutical Preparations Modulating Bone metabolism | Selective Estrogen Receptor Modulators | Diphosphonates | Parathyroid Hormone | RANK Ligand Inhibitor
Item
patients who currently receive and/or received bone metabolism modulating agents including selective estrogen receptor modulators (serms), bisphosphonates, parathyroid hormone or anti-receptor activator of nuclear factor-kappab ligand (rankl) therapy.
boolean
C0013227 (UMLS CUI [1,1])
C0443264 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C0732611 (UMLS CUI [2])
C0012544 (UMLS CUI [3])
C0030520 (UMLS CUI [4])
C3665044 (UMLS CUI [5])
Patients Ineligible TNF alpha inhibitor
Item
subjects who are not eligible for tnf-blocking therapy according to the czech national registry (attra).
boolean
C0030705 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C4521709 (UMLS CUI [1,3])
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