ID

19234

Description

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Rheumatoid Arthritis With Ongoing Treatment With Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT00619905

Link

https://clinicaltrials.gov/show/NCT00619905

Keywords

Versions (1)
  1. 12/14/16 12/14/16 -
Uploaded on

December 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00619905

English

Eligibility Rheumatoid Arthritis NCT00619905

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients aged 18.5 - 65/75 years (depending on the dose group).
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of rheumatoid arthritis (acr 1987 revised classification for criteria for ra) with a disease duration of at least 6 months prior to randomization.
Description

Rheumatoid Arthritis disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
active disease at screening and baseline evaluation (same evaluator) ) with more than 6 tender and 6 swollen joints of 28 examined (including any effused joint) and either a) westergren erythrocyte sedimentation (esr) ≥ 28 mm/hour, or b) crp ≥ 6 mg/l.
Description

Disease | Evaluation | Joints tender Quantity | Joints swollen Quantity | Examination of joint Quantity | Hydrarthrosis | Sedimentation rate, Westergren | C-reactive protein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1261322
UMLS CUI [3,1]
C0240094
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0152031
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C0562263
UMLS CUI [5,2]
C1265611
UMLS CUI [6]
C1253936
UMLS CUI [7]
C0200705
UMLS CUI [8]
C0201657
patients should have failed at least 1 dmard in the past, but should not be deemed "refractory to all therapies"
Description

Disease-Modifying Antirheumatic Drugs Quantity failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
patients should have a current treatment regimen of ≥ 15 mg methotrexate/week and with the current dose stable for approximately 3 months.
Description

Methotrexate Dose Stable U/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
patients were required to have an otherwise stable ra therapeutic regimen, consisting of either a stable dose of nsaids and/or a stable dose of oral corticosteroids (prednisone or equivalent < 10 mg daily) for at least 4 weeks prior to randomization.
Description

Therapeutic procedure Stable Rheumatoid Arthritis | Non-Steroidal Anti-Inflammatory Agents Dose Stable | Adrenal Cortex Hormones Oral Dose Stable | Prednisone U/day | Prednisone Equivalent U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0003873
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205360
UMLS CUI [4,1]
C0032952
UMLS CUI [4,2]
C0456683
UMLS CUI [5,1]
C0032952
UMLS CUI [5,2]
C0205163
UMLS CUI [5,3]
C0456683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with anti-tnf-α antibody therapy (or other biological therapy) within appropriate timeframe (considering the half life of the compound)
Description

anti-tumor necrosis factor therapy | Biological treatment

Data type

boolean

Alias
UMLS CUI [1]
C0281481
UMLS CUI [2]
C1531518
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 four weeks prior to randomization or require narcotic analgesics other than those accepted by the investigator for analgesia (e.g., codeine, tramadol, dextropropoxyphene)
Description

intraarticular injection of corticosteroids | corticosteroids injection Systemic | Therapeutic procedure Flare of rheumatoid arthritis Patient need for | Narcotic Analgesics Patient need for | Analgesia | Codeine | Tramadol | Propoxyphene

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
UMLS CUI [3,3]
C0686904
UMLS CUI [4,1]
C0027409
UMLS CUI [4,2]
C0686904
UMLS CUI [5]
C3202977
UMLS CUI [6]
C0009214
UMLS CUI [7]
C0040610
UMLS CUI [8]
C0033493
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 NCT00619905

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female patients aged 18.5 - 65/75 years (depending on the dose group).
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis disease length
Item
diagnosis of rheumatoid arthritis (acr 1987 revised classification for criteria for ra) with a disease duration of at least 6 months prior to randomization.
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Disease | Evaluation | Joints tender Quantity | Joints swollen Quantity | Examination of joint Quantity | Hydrarthrosis | Sedimentation rate, Westergren | C-reactive protein measurement
Item
active disease at screening and baseline evaluation (same evaluator) ) with more than 6 tender and 6 swollen joints of 28 examined (including any effused joint) and either a) westergren erythrocyte sedimentation (esr) ≥ 28 mm/hour, or b) crp ≥ 6 mg/l.
boolean
C0012634 (UMLS CUI [1])
C1261322 (UMLS CUI [2])
C0240094 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0152031 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0562263 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C1253936 (UMLS CUI [6])
C0200705 (UMLS CUI [7])
C0201657 (UMLS CUI [8])
Disease-Modifying Antirheumatic Drugs Quantity failed
Item
patients should have failed at least 1 dmard in the past, but should not be deemed "refractory to all therapies"
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Methotrexate Dose Stable U/week
Item
patients should have a current treatment regimen of ≥ 15 mg methotrexate/week and with the current dose stable for approximately 3 months.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Therapeutic procedure Stable Rheumatoid Arthritis | Non-Steroidal Anti-Inflammatory Agents Dose Stable | Adrenal Cortex Hormones Oral Dose Stable | Prednisone U/day | Prednisone Equivalent U/day
Item
patients were required to have an otherwise stable ra therapeutic regimen, consisting of either a stable dose of nsaids and/or a stable dose of oral corticosteroids (prednisone or equivalent < 10 mg daily) for at least 4 weeks prior to randomization.
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0001617 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C0032952 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0032952 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
anti-tumor necrosis factor therapy | Biological treatment
Item
previous treatment with anti-tnf-α antibody therapy (or other biological therapy) within appropriate timeframe (considering the half life of the compound)
boolean
C0281481 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
intraarticular injection of corticosteroids | corticosteroids injection Systemic | Therapeutic procedure Flare of rheumatoid arthritis Patient need for | Narcotic Analgesics Patient need for | Analgesia | Codeine | Tramadol | Propoxyphene
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 four weeks prior to randomization or require narcotic analgesics other than those accepted by the investigator for analgesia (e.g., codeine, tramadol, dextropropoxyphene)
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])
C0686904 (UMLS CUI [3,3])
C0027409 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
C3202977 (UMLS CUI [5])
C0009214 (UMLS CUI [6])
C0040610 (UMLS CUI [7])
C0033493 (UMLS CUI [8])
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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