ID

44096

Description

Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00650078

Link

https://clinicaltrials.gov/show/NCT00650078

Keywords

Versions (3)
  1. 10/2/18 10/2/18 -
  2. 10/2/18 10/2/18 -
  3. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00650078

English

Eligibility Rheumatoid Arthritis NCT00650078

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented history of ra in agreement with acr criteria
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
dmard treatment for ra greater than or equal to 6 months, with a stable dose greater than or equal to 6 weeks prior to screening visit
Description

DMARD Dose Stable Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0003873
duration of morning stiffness greater than or equal to 45 minutes
Description

Morning stiffness Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0457086
UMLS CUI [1,2]
C0449238
greater than or equal to 4 swollen joints (out of 28)
Description

Swollen joint count

Data type

boolean

Alias
UMLS CUI [1]
C0451521
greater than or equal to 4 tender joints (out of 28)
Description

Tender joint count

Data type

boolean

Alias
UMLS CUI [1]
C0451530
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
suffering from another disease, which requires glucocorticoid treatment during the study period
Description

Disease Requirement Glucocorticoids

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0017710
synovectomy within 4 months prior to study start
Description

Synovectomy

Data type

boolean

Alias
UMLS CUI [1]
C0185304
use of glucocorticoids:
Description

Glucocorticoids

Data type

boolean

Alias
UMLS CUI [1]
C0017710
continued use of systemic glucocorticoids within 4 weeks prior to screening visit
Description

Glucocorticoids, Systemic

Data type

boolean

Alias
UMLS CUI [1]
C3540777
intermittent use of glucocorticoids within 2 weeks prior to screening visit.
Description

Glucocorticoids Intermittent administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C0444735
joint injections within 6 weeks prior to screening visit
Description

Joint injection

Data type

boolean

Alias
UMLS CUI [1]
C0021488
topical glucocorticoids must be stopped at screening visit
Description

Topical glucocorticoid To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0017712
UMLS CUI [1,2]
C1272691
use of biologicals such as: tumor necrosis factor α (tnfα) inhibitors and other compounds within 5 serum half lives prior to screening visit
Description

Biological agents | Tumor necrosis factor alpha (TNF-) inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0005515
UMLS CUI [2]
C3653350
pregnancy or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Rheumatoid Arthritis NCT00650078

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
documented history of ra in agreement with acr criteria
boolean
C0003873 (UMLS CUI [1])
DMARD Dose Stable Rheumatoid Arthritis
Item
dmard treatment for ra greater than or equal to 6 months, with a stable dose greater than or equal to 6 weeks prior to screening visit
boolean
C0242708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003873 (UMLS CUI [1,4])
Morning stiffness Duration
Item
duration of morning stiffness greater than or equal to 45 minutes
boolean
C0457086 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Swollen joint count
Item
greater than or equal to 4 swollen joints (out of 28)
boolean
C0451521 (UMLS CUI [1])
Tender joint count
Item
greater than or equal to 4 tender joints (out of 28)
boolean
C0451530 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Requirement Glucocorticoids
Item
suffering from another disease, which requires glucocorticoid treatment during the study period
boolean
C0012634 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0017710 (UMLS CUI [1,3])
Synovectomy
Item
synovectomy within 4 months prior to study start
boolean
C0185304 (UMLS CUI [1])
Glucocorticoids
Item
use of glucocorticoids:
boolean
C0017710 (UMLS CUI [1])
Glucocorticoids, Systemic
Item
continued use of systemic glucocorticoids within 4 weeks prior to screening visit
boolean
C3540777 (UMLS CUI [1])
Glucocorticoids Intermittent administration
Item
intermittent use of glucocorticoids within 2 weeks prior to screening visit.
boolean
C0017710 (UMLS CUI [1,1])
C0444735 (UMLS CUI [1,2])
Joint injection
Item
joint injections within 6 weeks prior to screening visit
boolean
C0021488 (UMLS CUI [1])
Topical glucocorticoid To be stopped
Item
topical glucocorticoids must be stopped at screening visit
boolean
C0017712 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Biological agents | Tumor necrosis factor alpha (TNF-) inhibitors
Item
use of biologicals such as: tumor necrosis factor α (tnfα) inhibitors and other compounds within 5 serum half lives prior to screening visit
boolean
C0005515 (UMLS CUI [1])
C3653350 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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