ID

36158

Beschreibung

Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02144272

Link

https://clinicaltrials.gov/show/NCT02144272

Stichworte

Versionen (1)
  1. 18.04.19 18.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. April 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Inflammatory Arthritis NCT02144272

Englisch

Eligibility Inflammatory Arthritis NCT02144272

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
signs or symptoms of an inflammatory arthritis for a duration of at least 8 weeks at screening.
Beschreibung

Sign or Symptom Arthritis Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0003864
UMLS CUI [1,3]
C0449238
presence of at least 3 out of 66 swollen joints at screening and baseline, as determined by the swollen joint count assessment forms.
Beschreibung

Swollen joint count

Datentyp

boolean

Alias
UMLS CUI [1]
C0451521
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
synthetic disease-modifying antirheumatic drugs dmard use as follows:
Beschreibung

Synthetic Disease-Modifying Antirheumatic Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1883254
any treatment with tofacitinib within 28 days prior to baseline or planned treatment with tofacitinib during the study;
Beschreibung

Tofacitinib | Tofacitinib Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C2930696
UMLS CUI [2,1]
C2930696
UMLS CUI [2,2]
C1301732
treatment with other synthetic dmards (eg, hydroxychloroquine, methothrexate, leflunomide, sulfasalazine, and gold salts) at an unstable dose within 28 days prior to baseline or if the dose of drug is planned to be changed during the study.
Beschreibung

Synthetic Disease-Modifying Antirheumatic Drugs Dose Unstable | Synthetic Disease-Modifying Antirheumatic Drugs Change in drug dosage Planned | Hydroxychloroquine | Methotrexate | leflunomide | Sulfasalazine | Gold salt

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1883254
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0443343
UMLS CUI [2,1]
C0242708
UMLS CUI [2,2]
C1883254
UMLS CUI [2,3]
C0420247
UMLS CUI [2,4]
C1301732
UMLS CUI [3]
C0020336
UMLS CUI [4]
C0025677
UMLS CUI [5]
C0063041
UMLS CUI [6]
C0036078
UMLS CUI [7]
C0302210
previous treatment with marketed biologic dmards as follows:
Beschreibung

Biologic Disease-Modifying Antirheumatic Drug

Datentyp

boolean

Alias
UMLS CUI [1]
C4055380
etanercept, adalimumab, or anakinra <4 weeks prior to baseline;
Beschreibung

Etanercept | adalimumab | anakinra

Datentyp

boolean

Alias
UMLS CUI [1]
C0717758
UMLS CUI [2]
C1122087
UMLS CUI [3]
C0245109
infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab <8 weeks prior to baseline;
Beschreibung

infliximab | certolizumab pegol | golimumab | abatacept | tocilizumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0666743
UMLS CUI [2]
C1872109
UMLS CUI [3]
C2353893
UMLS CUI [4]
C1619966
UMLS CUI [5]
C1609165
rituximab <12 months prior to baseline
Beschreibung

rituximab

Datentyp

boolean

Alias
UMLS CUI [1]
C0393022
note: other biologic agents for indications other than an inflammatory arthritis may be allowed after discussion with the sponsor
Beschreibung

Exception Indication Arthritis | Biological agents allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0003864
UMLS CUI [2,1]
C0005515
UMLS CUI [2,2]
C0683607
treatment with >10 mg/day, or unstable dose, of oral prednisone or equivalent within 28 days prior to baseline.
Beschreibung

Prednisone Oral U/day | Prednisone Oral Dose Unstable | Prednisone Oral Equivalent U/day | Prednisone Oral Equivalent Dose Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3216040
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C3216040
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0443343
UMLS CUI [3,1]
C3216040
UMLS CUI [3,2]
C0205163
UMLS CUI [3,3]
C0456683
UMLS CUI [4,1]
C3216040
UMLS CUI [4,2]
C0205163
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C0443343
confirmed or suspected septic arthritis, crystal arthropathy, systemic lupus erythematosus, reactive arthritis, or certain other rheumatic conditions.
Beschreibung

Septic Arthritis | Septic Arthritis Suspected | Crystal Arthropathy | Lupus Erythematosus, Systemic | Arthritis, Reactive | Rheumatic disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0003869
UMLS CUI [2,1]
C0003869
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0152087
UMLS CUI [4]
C0024141
UMLS CUI [5]
C0085435
UMLS CUI [6]
C3495832
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Ähnliche Modelle

Eligibility Inflammatory Arthritis NCT02144272

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Sign or Symptom Arthritis Duration
Item
signs or symptoms of an inflammatory arthritis for a duration of at least 8 weeks at screening.
boolean
C3540840 (UMLS CUI [1,1])
C0003864 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Swollen joint count
Item
presence of at least 3 out of 66 swollen joints at screening and baseline, as determined by the swollen joint count assessment forms.
boolean
C0451521 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Synthetic Disease-Modifying Antirheumatic Drugs
Item
synthetic disease-modifying antirheumatic drugs dmard use as follows:
boolean
C0242708 (UMLS CUI [1,1])
C1883254 (UMLS CUI [1,2])
Tofacitinib | Tofacitinib Planned
Item
any treatment with tofacitinib within 28 days prior to baseline or planned treatment with tofacitinib during the study;
boolean
C2930696 (UMLS CUI [1])
C2930696 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Synthetic Disease-Modifying Antirheumatic Drugs Dose Unstable | Synthetic Disease-Modifying Antirheumatic Drugs Change in drug dosage Planned | Hydroxychloroquine | Methotrexate | leflunomide | Sulfasalazine | Gold salt
Item
treatment with other synthetic dmards (eg, hydroxychloroquine, methothrexate, leflunomide, sulfasalazine, and gold salts) at an unstable dose within 28 days prior to baseline or if the dose of drug is planned to be changed during the study.
boolean
C0242708 (UMLS CUI [1,1])
C1883254 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0443343 (UMLS CUI [1,4])
C0242708 (UMLS CUI [2,1])
C1883254 (UMLS CUI [2,2])
C0420247 (UMLS CUI [2,3])
C1301732 (UMLS CUI [2,4])
C0020336 (UMLS CUI [3])
C0025677 (UMLS CUI [4])
C0063041 (UMLS CUI [5])
C0036078 (UMLS CUI [6])
C0302210 (UMLS CUI [7])
Biologic Disease-Modifying Antirheumatic Drug
Item
previous treatment with marketed biologic dmards as follows:
boolean
C4055380 (UMLS CUI [1])
Etanercept | adalimumab | anakinra
Item
etanercept, adalimumab, or anakinra <4 weeks prior to baseline;
boolean
C0717758 (UMLS CUI [1])
C1122087 (UMLS CUI [2])
C0245109 (UMLS CUI [3])
infliximab | certolizumab pegol | golimumab | abatacept | tocilizumab
Item
infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab <8 weeks prior to baseline;
boolean
C0666743 (UMLS CUI [1])
C1872109 (UMLS CUI [2])
C2353893 (UMLS CUI [3])
C1619966 (UMLS CUI [4])
C1609165 (UMLS CUI [5])
rituximab
Item
rituximab <12 months prior to baseline
boolean
C0393022 (UMLS CUI [1])
Exception Indication Arthritis | Biological agents allowed
Item
note: other biologic agents for indications other than an inflammatory arthritis may be allowed after discussion with the sponsor
boolean
C1705847 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0003864 (UMLS CUI [1,3])
C0005515 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Prednisone Oral U/day | Prednisone Oral Dose Unstable | Prednisone Oral Equivalent U/day | Prednisone Oral Equivalent Dose Unstable
Item
treatment with >10 mg/day, or unstable dose, of oral prednisone or equivalent within 28 days prior to baseline.
boolean
C3216040 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C3216040 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
C3216040 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C3216040 (UMLS CUI [4,1])
C0205163 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0443343 (UMLS CUI [4,4])
Septic Arthritis | Septic Arthritis Suspected | Crystal Arthropathy | Lupus Erythematosus, Systemic | Arthritis, Reactive | Rheumatic disorder
Item
confirmed or suspected septic arthritis, crystal arthropathy, systemic lupus erythematosus, reactive arthritis, or certain other rheumatic conditions.
boolean
C0003869 (UMLS CUI [1])
C0003869 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0152087 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0085435 (UMLS CUI [5])
C3495832 (UMLS CUI [6])
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