ID

12560

Descrizione

A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, Administered to Patients With Rheumatoid Arthritis to Determine Safety, Tolerability, Pharmacokinetic and Synovial Tissue Outcomes; ODM derived from: https://clinicaltrials.gov/show/NCT00642629

collegamento

https://clinicaltrials.gov/show/NCT00642629

Keywords

versioni (1)
  1. 30/11/15 30/11/15 -
Caricato su

30 novembre 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Active, Moderate to Severe Rheumatoid Arthritis NCT00642629

Inglese

Eligibility Active, Moderate to Severe Rheumatoid Arthritis NCT00642629

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female 18 years of age or older.
Descrizione

Patient sex and age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0150831
UMLS CUI [2]
C0001779
has diagnosis of ra in conformance with the american college of rheumatology (acr) criteria for at least 6 months.
Descrizione

Diagnosis of Rheumatoid arthritis for at least 6 months

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0003873
has at least one knee, wrist, or ankle that has active synovitis and is amenable to arthroscopic procedures for the acquisition of synovial tissue via biopsy.
Descrizione

active synovitis and is amenable to arthroscopic procedures

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0039103
UMLS CUI [2]
C0750934
must be taking methotrexate for a minimum of 4 months prior to day 1, with a stable dose regimen for at least 2 months, and
Descrizione

must be taking methotrexate with a stable dose regimen

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0746573
UMLS CUI [1,2]
C0205360
have plans to remain on the stable dose regimen of methotrexate for the duration of this study.
Descrizione

have plans to remain on the stable dose regimen of methotrexate for the duration of this study.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1321605
if female of childbearing potential, must be neither pregnant nor breast feeding, and
Descrizione

if female of childbearing potential, must be neither pregnant nor breast feeding

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
must have a negative pregnancy test (serum β-hcg) within 1 week of day 1. must be willing to use "double-barrier" contraception methods for the duration of the study.
Descrizione

negative pregnancy test must be willing to use

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2]
C0700589
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
is taking any disease-modifying anti-rheumatic drug (dmard) other than mtx concomitantly or within 1 month prior to day 1.
Descrizione

is taking any disease-modifying anti-rheumatic drug (dmard) other than mtx

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0242708
a positive (≥10 mm) tuberculin (ppd) skin test, unless the patient has had prior bcg immunization or has received prior suppressive treatment such as 1 year of inh.
Descrizione

positive (≥10 mm) tuberculin (ppd) skin test

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3161220
has received any investigational drug or experimental procedure for the treatment of ra within 3 months of day 1 for a biologic compound or within 1 month of day 1 for a non-biologic compound.
Descrizione

has received any investigational drug or experimental procedure for the treatment of ra

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
has any clinically significant disease that, in the opinion of the investigator, would make the patient an unsuitable candidate for this trial.
Descrizione

(e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrine, psychiatric, hematologic, urologic, or other acute or chronic illness)

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
Ritorna all'inizio della pagina

Similar models

Eligibility Active, Moderate to Severe Rheumatoid Arthritis NCT00642629

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Patient sex and age
Item
male or female 18 years of age or older.
boolean
C0150831 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diagnosis of Rheumatoid arthritis for at least 6 months
Item
has diagnosis of ra in conformance with the american college of rheumatology (acr) criteria for at least 6 months.
boolean
C0003873 (UMLS CUI [1])
active synovitis and is amenable to arthroscopic procedures
Item
has at least one knee, wrist, or ankle that has active synovitis and is amenable to arthroscopic procedures for the acquisition of synovial tissue via biopsy.
boolean
C0039103 (UMLS CUI [1])
C0750934 (UMLS CUI [2])
must be taking methotrexate with a stable dose regimen
Item
must be taking methotrexate for a minimum of 4 months prior to day 1, with a stable dose regimen for at least 2 months, and
boolean
C0746573 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
have plans to remain on the stable dose regimen of methotrexate for the duration of this study.
Item
have plans to remain on the stable dose regimen of methotrexate for the duration of this study.
boolean
C1321605 (UMLS CUI [1])
if female of childbearing potential, must be neither pregnant nor breast feeding
Item
if female of childbearing potential, must be neither pregnant nor breast feeding, and
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
negative pregnancy test must be willing to use
Item
must have a negative pregnancy test (serum β-hcg) within 1 week of day 1. must be willing to use "double-barrier" contraception methods for the duration of the study.
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
is taking any disease-modifying anti-rheumatic drug (dmard) other than mtx
Item
is taking any disease-modifying anti-rheumatic drug (dmard) other than mtx concomitantly or within 1 month prior to day 1.
boolean
C2347852 (UMLS CUI [1,1])
C0242708 (UMLS CUI [1,2])
positive (≥10 mm) tuberculin (ppd) skin test
Item
a positive (≥10 mm) tuberculin (ppd) skin test, unless the patient has had prior bcg immunization or has received prior suppressive treatment such as 1 year of inh.
boolean
C3161220 (UMLS CUI [1])
has received any investigational drug or experimental procedure for the treatment of ra
Item
has received any investigational drug or experimental procedure for the treatment of ra within 3 months of day 1 for a biologic compound or within 1 month of day 1 for a non-biologic compound.
boolean
C2348568 (UMLS CUI [1])
has any clinically significant disease that would make the patient an unsuitable candidate for this trial.
Item
has any clinically significant disease that, in the opinion of the investigator, would make the patient an unsuitable candidate for this trial.
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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