ID

12560

Description

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

Link

https://clinicaltrials.gov/show/NCT00642629

Keywords

Versions (1)
  1. 11/30/15 11/30/15 -
Uploaded on

November 30, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Active, Moderate to Severe Rheumatoid Arthritis NCT00642629

English

Eligibility Active, Moderate to Severe Rheumatoid Arthritis NCT00642629

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Patient sex and age

Data type

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.
Description

Diagnosis of Rheumatoid arthritis for at least 6 months

Data type

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.
Description

active synovitis and is amenable to arthroscopic procedures

Data type

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
Description

must be taking methotrexate with a stable dose regimen

Data type

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.
Description

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

Data type

boolean

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

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

Data type

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.
Description

negative pregnancy test must be willing to use

Data type

boolean

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

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
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Similar models

Eligibility Active, Moderate to Severe Rheumatoid Arthritis NCT00642629

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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