ID

41785

Beschrijving

Pediatric Arthritis Study of Certolizumab Pegol; ODM derived from: https://clinicaltrials.gov/show/NCT01550003

Link

https://clinicaltrials.gov/show/NCT01550003

Trefwoorden

Versies (3)
  1. 20-01-21 20-01-21 - Ahmed Rafee, MD
  2. 21-01-21 21-01-21 - Ahmed Rafee, MD
  3. 22-01-21 22-01-21 - Sarah Riepenhausen
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20 januari 2021

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Creative Commons BY 4.0
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Eligibility Polyarticular-course Juvenile Idiopathic Arthritis (JIA) NCT01550003

Engels

Eligibility Polyarticular-course Juvenile Idiopathic Arthritis (JIA) NCT01550003

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
Onset of signs and symptoms consistent with a diagnosis of juvenile idiopathic arthritis (JIA) (according to the international league of associations for rheumatology classification of juvenile idiopathic arthritis, 2001) AND Initiation of JIA treatment for at least 6 months prior to baseline AND Active Polyarticular-course JIA disease (defined as ≥ 5 joints with active arthritis including: polyarticular rheumatoid factor (rf)-positive, polyarticular rf-negative, extended oligoarticular, juvenile psoriatic arthritis and enthesitis-related arthritis)
Beschrijving

Onset of Diagnosis of JIA and Initiation of treatment 6 months prior to baseline (Visit 2) | Diagnosis according to the International League of Associations for Rheumatology Classification of Juvenile Idiopathic Arthritis, 2001 | Active Polyarticular-course JIA

Datatype

boolean

Alias
UMLS CUI [1,1]
C3495559
UMLS CUI [1,2]
C4054703
UMLS CUI [2,1]
C4521004
UMLS CUI [2,2]
C2707252
UMLS CUI [2,3]
C3495559
children and adolescents, aged 2 to 17 years (inclusive); weight ≥ 10 kg
Beschrijving

Age | Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
inadequate response or intolerance to at least 1 disease-modifying antirheumatic drug (dmard) (previous exposure to a maximum of 2 biologic agents will be allowed)
Beschrijving

Unresponsive or intolerant to therapy | at least 1 DMARD | Maximum 2 biological agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C0277585
UMLS CUI [1,3]
C0242708
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0277585
UMLS CUI [2,3]
C0005515
UMLS CUI [2,4]
C1265611
have the study participant been on MTX for a minimum of 3 months at Screening AND have the dose been stable for at least 1 month before Screening at ≥10 to ≤15 mg/m^2 per week.
Beschrijving

(in case of current MTX-intake):

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0444921
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C0205360
have hte MTX-treatment been previously withdrawn for documented reasons of intolerability or inadequate response?
Beschrijving

(In case the study participant is currently not using MTX):

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0558681
UMLS CUI [1,3]
C0277585
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0420240
UMLS CUI [2,3]
C0877248
have the dose been stable for at least 7 days prior to the Baseline arthritis assessment at a maximum dose of 10 mg or 0.2 mg/kg prednisone (or equivalent) per day, whichever is the smaller dose?
Beschrijving

(If the study participant is using oral corticosteroid therapy):

Datatype

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C0205360
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Study participant has previously been exposed to more than 2 biologic agents
Beschrijving

Previous Exposure to 2 or more biological agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0005515
UMLS CUI [1,3]
C1265611
active uveitis or a history of active uveitis within the preceding 6 months
Beschrijving

Active Uveitis | Past history of active Uveitis in the last 6 Months

Datatype

boolean

Alias
UMLS CUI [1,1]
C2707252
UMLS CUI [1,2]
C0042164
UMLS CUI [2,1]
C0332119
UMLS CUI [2,2]
C0042164
Study participant has a current sign or symptom which may indicate infection (eg, fever, cough), a history of chronic or recurrent infections within the same organ system (more than 3 episodes requiring antibiotics/antivirals during the 12 months prior to Screening [Visit 1]), had a recent (within the 6 months prior to Screening [Visit 1]) serious or life-threatening infection (including herpes zoster), or is at a high risk of infection in the Investigator's opinion (eg, study participants with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound)
Beschrijving

Signs or symptoms of infection (e.g. fever or cough) | History of chronic infections | History of recurrent infections within the same system, more than 3 episodes requiring antibiotics/ antivirals 12 months prior to Visit 1 | Recent serious or life-threatening infection (including Herpes Zoster) within 6 months prior to Visit 1 | High risk of infection (e.g. leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound).

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0009450
UMLS CUI [2]
C0015967
UMLS CUI [3]
C0010200
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0151317
UMLS CUI [5,1]
C0262926
UMLS CUI [5,2]
C0239998
UMLS CUI [5,3]
C0460002
UMLS CUI [5,4]
C4086638
UMLS CUI [5,5]
C0338237
UMLS CUI [6,1]
C0262926
UMLS CUI [6,2]
C0239998
UMLS CUI [6,3]
C0460002
UMLS CUI [6,4]
C4086638
UMLS CUI [6,5]
C0280274
UMLS CUI [7,1]
C0009450
UMLS CUI [7,2]
C0332185
UMLS CUI [7,3]
C2826244
UMLS CUI [8]
C0019360
UMLS CUI [9,1]
C0332167
UMLS CUI [9,2]
C0009450
UMLS CUI [10]
C0023223
UMLS CUI [11]
C0521197
UMLS CUI [12,1]
C0425251
UMLS CUI [12,2]
C0205355
UMLS CUI [13]
C0558195
UMLS CUI [14,1]
C2945760
UMLS CUI [14,2]
C0009450
UMLS CUI [14,3]
C0817096
Study participant previously failed to respond to treatment with more than one tumor necrosis factor alpha (TNFα) antagonist drug
Beschrijving

Previous unresponsiveness to more than on TNFα Antagonists

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C3653350
UMLS CUI [1,3]
C1265611
Study participant is currently receiving or has received any experimental (biological or nonbiological) therapy (within or outside a clinical study) in the 3 months or 5 half-lives prior to Baseline (Visit 2), whichever is longer
Beschrijving

current or previous experimental therapy (biological or nonbiological) in the last 3 months

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0205156
Study participant had previous treatment with a biological therapy for juvenile idiopathic arthritis (JIA) that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
Beschrijving

Previous biological therapy with hypersensitivity or anaphylaxis

Datatype

boolean

Alias
UMLS CUI [1,1]
C1531518
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C0002792
Study participant previously participated in this study or has previously been treated with CZP (whether in a study or not)
Beschrijving

Previous participation in this study | Previous treatment with CZP

Datatype

boolean

Alias
UMLS CUI [1]
C2242969
UMLS CUI [2,1]
C0205156
UMLS CUI [2,2]
C1872109
Study participant has a secondary, noninflammatory type of rheumatic disease or of joint pains (eg, fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study medication
Beschrijving

Secondary noninflammatory rheumatic disease or joint pains (e.g. Fibormyalgia)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035435
UMLS CUI [1,2]
C0442743
UMLS CUI [1,3]
C0332138
UMLS CUI [2,1]
C0003862
UMLS CUI [2,2]
C0332138
UMLS CUI [3,1]
C0016053
UMLS CUI [3,2]
C0220825
UMLS CUI [3,3]
C0035173
Study participant has other inflammatory arthritis (eg, systemic lupus erythematosus, inflammatory bowel disease-related)
Beschrijving

Other inflammatory arthritis (e.g. SLE, IBD-associated)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0451528
UMLS CUI [3]
C0021390
Study participant has current, chronic or recurrent clinically significant infections
Beschrijving

Current chronic or recurrent clinically significant infections

Datatype

boolean

Alias
UMLS CUI [1,1]
C0151317
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0521116
UMLS CUI [2,3]
C2826293
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C2945760
UMLS CUI [3,3]
C2826293
history of systemic jia, with or without systemic features
Beschrijving

History of systemic JIA

Datatype

boolean

Alias
UMLS CUI [1]
C1384600
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Similar models

Eligibility Polyarticular-course Juvenile Idiopathic Arthritis (JIA) NCT01550003

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Onset of Diagnosis of JIA and Initiation of treatment 6 months prior to baseline (Visit 2) | Diagnosis according to the International League of Associations for Rheumatology Classification of Juvenile Idiopathic Arthritis, 2001 | Active Polyarticular-course JIA
Item
Onset of signs and symptoms consistent with a diagnosis of juvenile idiopathic arthritis (JIA) (according to the international league of associations for rheumatology classification of juvenile idiopathic arthritis, 2001) AND Initiation of JIA treatment for at least 6 months prior to baseline AND Active Polyarticular-course JIA disease (defined as ≥ 5 joints with active arthritis including: polyarticular rheumatoid factor (rf)-positive, polyarticular rf-negative, extended oligoarticular, juvenile psoriatic arthritis and enthesitis-related arthritis)
boolean
C3495559 (UMLS CUI [1,1])
C4054703 (UMLS CUI [1,2])
C4521004 (UMLS CUI [2,1])
C2707252 (UMLS CUI [2,2])
C3495559 (UMLS CUI [2,3])
Age | Weight
Item
children and adolescents, aged 2 to 17 years (inclusive); weight ≥ 10 kg
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Unresponsive or intolerant to therapy | at least 1 DMARD | Maximum 2 biological agents
Item
inadequate response or intolerance to at least 1 disease-modifying antirheumatic drug (dmard) (previous exposure to a maximum of 2 biologic agents will be allowed)
boolean
C0205269 (UMLS CUI [1,1])
C0277585 (UMLS CUI [1,2])
C0242708 (UMLS CUI [1,3])
C0205269 (UMLS CUI [2,1])
C0277585 (UMLS CUI [2,2])
C0005515 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
MTX-Therapy duration at least 3 months at screening| MTX-Dose must be stable in the last one month before screening
Item
have the study participant been on MTX for a minimum of 3 months at Screening AND have the dose been stable for at least 1 month before Screening at ≥10 to ≤15 mg/m^2 per week.
boolean
C0025677 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C3174092 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
MTX-Therapy stopped because of intolerance or adverse response
Item
have hte MTX-treatment been previously withdrawn for documented reasons of intolerability or inadequate response?
boolean
C0025677 (UMLS CUI [1,1])
C0558681 (UMLS CUI [1,2])
C0277585 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0420240 (UMLS CUI [2,2])
C0877248 (UMLS CUI [2,3])
Corticosteroid Dose stable
Item
have the dose been stable for at least 7 days prior to the Baseline arthritis assessment at a maximum dose of 10 mg or 0.2 mg/kg prednisone (or equivalent) per day, whichever is the smaller dose?
boolean
C0521116 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Previous Exposure to 2 or more biological agents
Item
Study participant has previously been exposed to more than 2 biologic agents
boolean
C0205156 (UMLS CUI [1,1])
C0005515 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Active Uveitis | Past history of active Uveitis in the last 6 Months
Item
active uveitis or a history of active uveitis within the preceding 6 months
boolean
C2707252 (UMLS CUI [1,1])
C0042164 (UMLS CUI [1,2])
C0332119 (UMLS CUI [2,1])
C0042164 (UMLS CUI [2,2])
Signs or symptoms of infection (e.g. fever or cough) | History of chronic infections | History of recurrent infections within the same system, more than 3 episodes requiring antibiotics/ antivirals 12 months prior to Visit 1 | Recent serious or life-threatening infection (including Herpes Zoster) within 6 months prior to Visit 1 | High risk of infection (e.g. leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound).
Item
Study participant has a current sign or symptom which may indicate infection (eg, fever, cough), a history of chronic or recurrent infections within the same organ system (more than 3 episodes requiring antibiotics/antivirals during the 12 months prior to Screening [Visit 1]), had a recent (within the 6 months prior to Screening [Visit 1]) serious or life-threatening infection (including herpes zoster), or is at a high risk of infection in the Investigator's opinion (eg, study participants with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound)
boolean
C0037088 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
C0010200 (UMLS CUI [3])
C0262926 (UMLS CUI [4,1])
C0151317 (UMLS CUI [4,2])
C0262926 (UMLS CUI [5,1])
C0239998 (UMLS CUI [5,2])
C0460002 (UMLS CUI [5,3])
C4086638 (UMLS CUI [5,4])
C0338237 (UMLS CUI [5,5])
C0262926 (UMLS CUI [6,1])
C0239998 (UMLS CUI [6,2])
C0460002 (UMLS CUI [6,3])
C4086638 (UMLS CUI [6,4])
C0280274 (UMLS CUI [6,5])
C0009450 (UMLS CUI [7,1])
C0332185 (UMLS CUI [7,2])
C2826244 (UMLS CUI [7,3])
C0019360 (UMLS CUI [8])
C0332167 (UMLS CUI [9,1])
C0009450 (UMLS CUI [9,2])
C0023223 (UMLS CUI [10])
C0521197 (UMLS CUI [11])
C0425251 (UMLS CUI [12,1])
C0205355 (UMLS CUI [12,2])
C0558195 (UMLS CUI [13])
C2945760 (UMLS CUI [14,1])
C0009450 (UMLS CUI [14,2])
C0817096 (UMLS CUI [14,3])
Previous unresponsiveness to more than on TNFα Antagonists
Item
Study participant previously failed to respond to treatment with more than one tumor necrosis factor alpha (TNFα) antagonist drug
boolean
C0205269 (UMLS CUI [1,1])
C3653350 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
current or previous experimental therapy (biological or nonbiological) in the last 3 months
Item
Study participant is currently receiving or has received any experimental (biological or nonbiological) therapy (within or outside a clinical study) in the 3 months or 5 half-lives prior to Baseline (Visit 2), whichever is longer
boolean
C0304229 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Previous biological therapy with hypersensitivity or anaphylaxis
Item
Study participant had previous treatment with a biological therapy for juvenile idiopathic arthritis (JIA) that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
boolean
C1531518 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C0002792 (UMLS CUI [2,2])
Previous participation in this study | Previous treatment with CZP
Item
Study participant previously participated in this study or has previously been treated with CZP (whether in a study or not)
boolean
C2242969 (UMLS CUI [1])
C0205156 (UMLS CUI [2,1])
C1872109 (UMLS CUI [2,2])
Secondary noninflammatory rheumatic disease or joint pains (e.g. Fibormyalgia)
Item
Study participant has a secondary, noninflammatory type of rheumatic disease or of joint pains (eg, fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study medication
boolean
C0035435 (UMLS CUI [1,1])
C0442743 (UMLS CUI [1,2])
C0332138 (UMLS CUI [1,3])
C0003862 (UMLS CUI [2,1])
C0332138 (UMLS CUI [2,2])
C0016053 (UMLS CUI [3,1])
C0220825 (UMLS CUI [3,2])
C0035173 (UMLS CUI [3,3])
Other inflammatory arthritis (e.g. SLE, IBD-associated)
Item
Study participant has other inflammatory arthritis (eg, systemic lupus erythematosus, inflammatory bowel disease-related)
boolean
C0003864 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0451528 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
Current chronic or recurrent clinically significant infections
Item
Study participant has current, chronic or recurrent clinically significant infections
boolean
C0151317 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
C2826293 (UMLS CUI [3,3])
History of systemic JIA
Item
history of systemic jia, with or without systemic features
boolean
C1384600 (UMLS CUI [1])
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