ID

25261

Description

Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00504595

Link

https://clinicaltrials.gov/show/NCT00504595

Keywords

Versions (1)
  1. 8/29/17 8/29/17 -
Uploaded on

August 29, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00504595

English

Eligibility Rheumatoid Arthritis NCT00504595

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ra patients:
Description

Rheumatoid Arthritis Patients

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0030705
male and female patients aged 18 - 75 years (inclusive).
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
body weight between 50 and 100 kg (inclusive).
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
post menopausal or surgically sterile female patients are allowed. female patients of child-bearing potential may participate if they are already on a stable dose of methotrexate. additional birth control details to be provided at screening. male patients must use an effective contraception method during the study and at least for 2 months following the completion/discontinuation of the study.
Description

Postmenopausal state | Female Sterilization | Childbearing Potential Methotrexate Dose Stable | Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0025677
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205360
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
diagnosis of ra, classified by american rheumatism association 1987 revised criteria. disease duration of at least 6 months is essential.
Description

Rheumatoid Arthritis disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
functional status class i, ii or iii classified according to the american college of rheumatology 1991 revised criteria.
Description

Rheumatoid Arthritis Functional Status Class

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
active disease evaluation (≥ 6 tender and ≥ 6 swollen joints)
Description

Disease Evaluation | Tender joint count | Swollen joint count

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1261322
UMLS CUI [2]
C0451530
UMLS CUI [3]
C0451521
prior treatment with 1-3 disease-modifying anti-rheumatic drugs (dmards) - patients should have failed at least 1 dmard but should not be deemed "refractory to all therapies". it is expected that patients are on a current treatment with methotrexate
Description

Disease-Modifying Antirheumatic Drugs Quantity failed | Methotrexate U/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0560588
≤ 25 mg/week and with the current dose stable for at least 3 months, however patients who did not tolerate mtx may also be considered. all patients will take folic acid 1 mg daily, or 5 mg weekly post mtx dose, to minimize toxicity, according to local guidelines. in addition to methotrexate, patients may be on either a stable dose of non-steroidal anti-inflammatory drugs (nsaids) and/or a stable dose of oral corticosteroids (prednisone or equivalent ≤ 10 mg daily) for at least 4 weeks prior to randomization. patients who failed any dmards will be allowed.
Description

Methotrexate Dose Stable | Intolerance to Methotrexate | Folic Acid U/day | Folic Acid U/week | Toxicity Reduction | Non-Steroidal Anti-Inflammatory Agents Dose Stable | Adrenal Cortex Hormones Oral Dose Stable | Prednisone U/day | Prednisone Equivalent U/day | Disease-Modifying Antirheumatic Drugs Any failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0025677
UMLS CUI [3,1]
C0016410
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C0016410
UMLS CUI [4,2]
C0560588
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C0392756
UMLS CUI [6,1]
C0003211
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
UMLS CUI [7,1]
C0001617
UMLS CUI [7,2]
C1527415
UMLS CUI [7,3]
C0178602
UMLS CUI [7,4]
C0205360
UMLS CUI [8,1]
C0032952
UMLS CUI [8,2]
C0456683
UMLS CUI [9,1]
C0032952
UMLS CUI [9,2]
C0205163
UMLS CUI [9,3]
C0456683
UMLS CUI [10,1]
C0242708
UMLS CUI [10,2]
C1552551
UMLS CUI [10,3]
C0231175
negative purified protein derivative (ppd) tuberculin skin test reaction (ppd 5 tuberculin units or as according to local standard practice).
Description

Tuberculin Test Negative | PPD of Tuberculin Units

Data type

boolean

Alias
UMLS CUI [1,1]
C0041290
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C0034131
UMLS CUI [2,2]
C1519795
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ra patients:
Description

Rheumatoid Arthritis Patients

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0030705
previous treatment with anti-tumor necrosis factor (tnf)-α or anti il-1 therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate or tacrolimus. the following washout period will be required for such patients to be eligible to participate in the trial.
Description

Anti-tumor necrosis factor therapy | Interleukin-1 Receptor Antagonist | Biological treatment | Immunosuppressive Agents | Cyclosporine | MYCOPHENOLATE | Tacrolimus

Data type

boolean

Alias
UMLS CUI [1]
C0281481
UMLS CUI [2]
C3536785
UMLS CUI [3]
C1531518
UMLS CUI [4]
C0021081
UMLS CUI [5]
C0010592
UMLS CUI [6]
C0883242
UMLS CUI [7]
C0085149
1. 2 months washout prior to screening for etanercept or adalimumab
Description

Washout Period | Etanercept | adalimumab

Data type

boolean

Alias
UMLS CUI [1]
C1710661
UMLS CUI [2]
C0717758
UMLS CUI [3]
C1122087
2. 3 months washout prior to screening for infliximab
Description

Washout Period | infliximab

Data type

boolean

Alias
UMLS CUI [1]
C1710661
UMLS CUI [2]
C0666743
3. 3 months washout prior to screening for rituximab
Description

Washout Period | rituximab

Data type

boolean

Alias
UMLS CUI [1]
C1710661
UMLS CUI [2]
C0393022
4. 1 month washout prior to screening for cyclosporine, mycophenolate and tacrolimus.
Description

Washout Period | Cyclosporine | MYCOPHENOLATE | Tacrolimus

Data type

boolean

Alias
UMLS CUI [1]
C1710661
UMLS CUI [2]
C0010592
UMLS CUI [3]
C0883242
UMLS CUI [4]
C0085149
if patient has been discontinued from other dmards (disease modifying antirheumatic drugs) for lack of efficacy or toxicity, the patient should be at least 1 month off the agent.
Description

Disease-Modifying Antirheumatic Drugs Discontinued Due to Lack of Efficacy | Disease-Modifying Antirheumatic Drugs Discontinued Due to Toxicity

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0235828
UMLS CUI [2,1]
C0242708
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0600688
patients with congestive heart failure, qt prolongation syndrome or poorly controlled diabetes mellitus. patients with a history of qtc prolongation will be excluded.
Description

Congestive heart failure | Long QT Syndrome | Diabetes mellitus poor control | QT corrected interval prolonged

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0023976
UMLS CUI [3]
C0860161
UMLS CUI [4]
C0855333
patients who have received intra-articular or systemic corticosteroid injections having been required for treatment of acute ra flare (not being part of a regular therapeutic regimen) within 4 weeks prior to randomization.
Description

Intraarticular injection of corticosteroids | Corticosteroids injection systemic | Therapeutic procedure Flare of rheumatoid arthritis

Data type

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2,1]
C2095490
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0581345
exclusion criteria 2-6 of the health volunteer section also applies here.
Description

ID.20

Data type

boolean

other protocol-defined inclusion/exclusion criteria may apply
Description

Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Rheumatoid Arthritis NCT00504595

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis Patients
Item
ra patients:
boolean
C0003873 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Age
Item
male and female patients aged 18 - 75 years (inclusive).
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
body weight between 50 and 100 kg (inclusive).
boolean
C0005910 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Childbearing Potential Methotrexate Dose Stable | Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
post menopausal or surgically sterile female patients are allowed. female patients of child-bearing potential may participate if they are already on a stable dose of methotrexate. additional birth control details to be provided at screening. male patients must use an effective contraception method during the study and at least for 2 months following the completion/discontinuation of the study.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0025677 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Rheumatoid Arthritis disease length
Item
diagnosis of ra, classified by american rheumatism association 1987 revised criteria. disease duration of at least 6 months is essential.
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Rheumatoid Arthritis Functional Status Class
Item
functional status class i, ii or iii classified according to the american college of rheumatology 1991 revised criteria.
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Disease Evaluation | Tender joint count | Swollen joint count
Item
active disease evaluation (≥ 6 tender and ≥ 6 swollen joints)
boolean
C0012634 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
Disease-Modifying Antirheumatic Drugs Quantity failed | Methotrexate U/week
Item
prior treatment with 1-3 disease-modifying anti-rheumatic drugs (dmards) - patients should have failed at least 1 dmard but should not be deemed "refractory to all therapies". it is expected that patients are on a current treatment with methotrexate
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0025677 (UMLS CUI [2,1])
C0560588 (UMLS CUI [2,2])
Methotrexate Dose Stable | Intolerance to Methotrexate | Folic Acid U/day | Folic Acid U/week | Toxicity Reduction | Non-Steroidal Anti-Inflammatory Agents Dose Stable | Adrenal Cortex Hormones Oral Dose Stable | Prednisone U/day | Prednisone Equivalent U/day | Disease-Modifying Antirheumatic Drugs Any failed
Item
≤ 25 mg/week and with the current dose stable for at least 3 months, however patients who did not tolerate mtx may also be considered. all patients will take folic acid 1 mg daily, or 5 mg weekly post mtx dose, to minimize toxicity, according to local guidelines. in addition to methotrexate, patients may be on either a stable dose of non-steroidal anti-inflammatory drugs (nsaids) and/or a stable dose of oral corticosteroids (prednisone or equivalent ≤ 10 mg daily) for at least 4 weeks prior to randomization. patients who failed any dmards will be allowed.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
C0016410 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0016410 (UMLS CUI [4,1])
C0560588 (UMLS CUI [4,2])
C0600688 (UMLS CUI [5,1])
C0392756 (UMLS CUI [5,2])
C0003211 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0001617 (UMLS CUI [7,1])
C1527415 (UMLS CUI [7,2])
C0178602 (UMLS CUI [7,3])
C0205360 (UMLS CUI [7,4])
C0032952 (UMLS CUI [8,1])
C0456683 (UMLS CUI [8,2])
C0032952 (UMLS CUI [9,1])
C0205163 (UMLS CUI [9,2])
C0456683 (UMLS CUI [9,3])
C0242708 (UMLS CUI [10,1])
C1552551 (UMLS CUI [10,2])
C0231175 (UMLS CUI [10,3])
Tuberculin Test Negative | PPD of Tuberculin Units
Item
negative purified protein derivative (ppd) tuberculin skin test reaction (ppd 5 tuberculin units or as according to local standard practice).
boolean
C0041290 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0034131 (UMLS CUI [2,1])
C1519795 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Rheumatoid Arthritis Patients
Item
ra patients:
boolean
C0003873 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Anti-tumor necrosis factor therapy | Interleukin-1 Receptor Antagonist | Biological treatment | Immunosuppressive Agents | Cyclosporine | MYCOPHENOLATE | Tacrolimus
Item
previous treatment with anti-tumor necrosis factor (tnf)-α or anti il-1 therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate or tacrolimus. the following washout period will be required for such patients to be eligible to participate in the trial.
boolean
C0281481 (UMLS CUI [1])
C3536785 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
C0010592 (UMLS CUI [5])
C0883242 (UMLS CUI [6])
C0085149 (UMLS CUI [7])
Washout Period | Etanercept | adalimumab
Item
1. 2 months washout prior to screening for etanercept or adalimumab
boolean
C1710661 (UMLS CUI [1])
C0717758 (UMLS CUI [2])
C1122087 (UMLS CUI [3])
Washout Period | infliximab
Item
2. 3 months washout prior to screening for infliximab
boolean
C1710661 (UMLS CUI [1])
C0666743 (UMLS CUI [2])
Washout Period | rituximab
Item
3. 3 months washout prior to screening for rituximab
boolean
C1710661 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
Washout Period | Cyclosporine | MYCOPHENOLATE | Tacrolimus
Item
4. 1 month washout prior to screening for cyclosporine, mycophenolate and tacrolimus.
boolean
C1710661 (UMLS CUI [1])
C0010592 (UMLS CUI [2])
C0883242 (UMLS CUI [3])
C0085149 (UMLS CUI [4])
Disease-Modifying Antirheumatic Drugs Discontinued Due to Lack of Efficacy | Disease-Modifying Antirheumatic Drugs Discontinued Due to Toxicity
Item
if patient has been discontinued from other dmards (disease modifying antirheumatic drugs) for lack of efficacy or toxicity, the patient should be at least 1 month off the agent.
boolean
C0242708 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0235828 (UMLS CUI [1,4])
C0242708 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0600688 (UMLS CUI [2,4])
Congestive heart failure | Long QT Syndrome | Diabetes mellitus poor control | QT corrected interval prolonged
Item
patients with congestive heart failure, qt prolongation syndrome or poorly controlled diabetes mellitus. patients with a history of qtc prolongation will be excluded.
boolean
C0018802 (UMLS CUI [1])
C0023976 (UMLS CUI [2])
C0860161 (UMLS CUI [3])
C0855333 (UMLS CUI [4])
Intraarticular injection of corticosteroids | Corticosteroids injection systemic | Therapeutic procedure Flare of rheumatoid arthritis
Item
patients who have received intra-articular or systemic corticosteroid injections having been required for treatment of acute ra flare (not being part of a regular therapeutic regimen) within 4 weeks prior to randomization.
boolean
C2064783 (UMLS CUI [1])
C2095490 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0581345 (UMLS CUI [3,2])
ID.20
Item
exclusion criteria 2-6 of the health volunteer section also applies here.
boolean
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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