ID

15954

Description

A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02287922

Link

https://clinicaltrials.gov/show/NCT02287922

Keywords

Versions (1)
  1. 6/20/16 6/20/16 -
Uploaded on

June 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02287922

English

Eligibility Rheumatoid Arthritis NCT02287922

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of ra (according to the 2010 eular/americal college of rheumatology (acr) classification criteria) for at least 6 months prior to screening, and acr functional class i-iii.
Description

Rheumatoid Arthritis | American College of Rheumatology Improvement Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C3273747
received previous or current treatment with methotrexate (mtx), and is considered intolerant to mtx, or for whom continued treatment with mtx is inappropriate or has contraindications for mtx use.
Description

Therapeutic procedure Methotrexate | intolerance to Methotrexate | Medical contraindication Methotrexate

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0025677
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0025677
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0025677
subjects must not have received mtx for at least 4 weeks before first administration of the study drug.
Description

Methotrexate Intake Before Investigational New Drug Administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0013230
UMLS CUI [1,5]
C1533734
have active ra with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline, and c reactive protein (crp) >= 1.2 times uln (upper limit of normal) at screening
Description

Rheumatoid Arthritis | Joint swelling | Joint tenderness | Swollen joint count | Tender joint count | C-reactive protein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0152031
UMLS CUI [3]
C0240094
UMLS CUI [4]
C0451521
UMLS CUI [5]
C0451530
UMLS CUI [6]
C0201657
others as defined in the protocol
Description

Inclusion criteria Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205394
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have been treated with dmards(disease modifying antirheumatic drugs)/systemic immunosuppressives during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug.
Description

Therapeutic procedure Antirheumatic Drugs, Disease-Modifying | Therapeutic procedure Immunosuppressive Agents Systemic | Hydroxychloroquine | Chloroquine | leflunomide | Washout Period

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0242708
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0021081
UMLS CUI [2,3]
C0205373
UMLS CUI [3]
C0020336
UMLS CUI [4]
C0008269
UMLS CUI [5]
C0063041
UMLS CUI [6]
C1710661
have received approved or investigational biological or targeted synthetic dmard therapies for ra (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or janus kinase [jak]-inhibitors) less than 6 months prior to screening.
Description

Rheumatoid Arthritis | Therapeutic procedure Biologic DMARD | Targeted Therapy DMARD Synthetic | Tumor necrosis factor alpha (TNF-) inhibitors | abatacept | rituximab | Janus Kinase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C4055380
UMLS CUI [3,1]
C2985566
UMLS CUI [3,2]
C0242708
UMLS CUI [3,3]
C1883254
UMLS CUI [4]
C3653350
UMLS CUI [5]
C1619966
UMLS CUI [6]
C0393022
UMLS CUI [7]
C3856094
have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic dmards (including jak inhibitors), for ra.
Description

Rheumatoid Arthritis | Biological treatment | Toxic effect | Intolerance | Unresponsive to Treatment | Disease Response Inadequate | Targeted Therapy | Disease-Modifying Antirheumatic Drugs Synthetic | Janus Kinase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0600688
UMLS CUI [4]
C1744706
UMLS CUI [5]
C0205269
UMLS CUI [6,1]
C1704632
UMLS CUI [6,2]
C0205412
UMLS CUI [7]
C2985566
UMLS CUI [8,1]
C0242708
UMLS CUI [8,2]
C1883254
UMLS CUI [9]
C3856094
have received prior therapy blocking the interleukin-6 (il-6) pathway, at any time.
Description

Prior Therapy Blocking Interleukin-6 Pathway

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332206
UMLS CUI [1,3]
C0021760
UMLS CUI [1,4]
C0037080
others as defined in the protocol.
Description

Exclusion Criteria Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Rheumatoid Arthritis NCT02287922

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis | American College of Rheumatology Improvement Criteria
Item
diagnosis of ra (according to the 2010 eular/americal college of rheumatology (acr) classification criteria) for at least 6 months prior to screening, and acr functional class i-iii.
boolean
C0003873 (UMLS CUI [1])
C3273747 (UMLS CUI [2])
Therapeutic procedure Methotrexate | intolerance to Methotrexate | Medical contraindication Methotrexate
Item
received previous or current treatment with methotrexate (mtx), and is considered intolerant to mtx, or for whom continued treatment with mtx is inappropriate or has contraindications for mtx use.
boolean
C0087111 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0025677 (UMLS CUI [3,2])
Methotrexate Intake Before Investigational New Drug Administration
Item
subjects must not have received mtx for at least 4 weeks before first administration of the study drug.
boolean
C0025677 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C1533734 (UMLS CUI [1,5])
Rheumatoid Arthritis | Joint swelling | Joint tenderness | Swollen joint count | Tender joint count | C-reactive protein measurement
Item
have active ra with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline, and c reactive protein (crp) >= 1.2 times uln (upper limit of normal) at screening
boolean
C0003873 (UMLS CUI [1])
C0152031 (UMLS CUI [2])
C0240094 (UMLS CUI [3])
C0451521 (UMLS CUI [4])
C0451530 (UMLS CUI [5])
C0201657 (UMLS CUI [6])
Inclusion criteria Other
Item
others as defined in the protocol
boolean
C1512693 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Antirheumatic Drugs, Disease-Modifying | Therapeutic procedure Immunosuppressive Agents Systemic | Hydroxychloroquine | Chloroquine | leflunomide | Washout Period
Item
have been treated with dmards(disease modifying antirheumatic drugs)/systemic immunosuppressives during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug.
boolean
C0087111 (UMLS CUI [1,1])
C0242708 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0021081 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
C0020336 (UMLS CUI [3])
C0008269 (UMLS CUI [4])
C0063041 (UMLS CUI [5])
C1710661 (UMLS CUI [6])
Rheumatoid Arthritis | Therapeutic procedure Biologic DMARD | Targeted Therapy DMARD Synthetic | Tumor necrosis factor alpha (TNF-) inhibitors | abatacept | rituximab | Janus Kinase Inhibitors
Item
have received approved or investigational biological or targeted synthetic dmard therapies for ra (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or janus kinase [jak]-inhibitors) less than 6 months prior to screening.
boolean
C0003873 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C4055380 (UMLS CUI [2,2])
C2985566 (UMLS CUI [3,1])
C0242708 (UMLS CUI [3,2])
C1883254 (UMLS CUI [3,3])
C3653350 (UMLS CUI [4])
C1619966 (UMLS CUI [5])
C0393022 (UMLS CUI [6])
C3856094 (UMLS CUI [7])
Rheumatoid Arthritis | Biological treatment | Toxic effect | Intolerance | Unresponsive to Treatment | Disease Response Inadequate | Targeted Therapy | Disease-Modifying Antirheumatic Drugs Synthetic | Janus Kinase Inhibitors
Item
have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic dmards (including jak inhibitors), for ra.
boolean
C0003873 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0600688 (UMLS CUI [3])
C1744706 (UMLS CUI [4])
C0205269 (UMLS CUI [5])
C1704632 (UMLS CUI [6,1])
C0205412 (UMLS CUI [6,2])
C2985566 (UMLS CUI [7])
C0242708 (UMLS CUI [8,1])
C1883254 (UMLS CUI [8,2])
C3856094 (UMLS CUI [9])
Prior Therapy Blocking Interleukin-6 Pathway
Item
have received prior therapy blocking the interleukin-6 (il-6) pathway, at any time.
boolean
C1514463 (UMLS CUI [1,1])
C0332206 (UMLS CUI [1,2])
C0021760 (UMLS CUI [1,3])
C0037080 (UMLS CUI [1,4])
Exclusion Criteria Other
Item
others as defined in the protocol.
boolean
C0680251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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