ID

31948

Beskrivning

Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01023256

Länk

https://clinicaltrials.gov/show/NCT01023256

Nyckelord

Versioner (1)
  1. 2018-10-08 2018-10-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01023256

Engelsk

Eligibility Rheumatoid Arthritis NCT01023256

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
rheumatoid arthritis (ra) per revised 1987 acr criteria
Beskrivning

Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
active ra: ≥3 swollen and 3 tender joints with at least 1 swollen joint in the hand, excluding the pip joint
Beskrivning

Rheumatoid Arthritis | Swollen joint count | Tender joint count | Hand joint swollen Quantity | Exception Proximal interphalangeal joint

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0451521
UMLS CUI [3]
C0451530
UMLS CUI [4,1]
C0459470
UMLS CUI [4,2]
C0038999
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0932508
crp > 5.0 mg/l (rf and anti-ccp seronegative); crp >2 mg/l (rf and/or anti-ccp seropositive)
Beskrivning

C-reactive protein measurement | Rheumatoid Factor Seronegative | Anti-CCP Seronegative | Rheumatoid Factor Seropositive | Anti-CCP Seropositive

Datatyp

boolean

Alias
UMLS CUI [1]
C0201657
UMLS CUI [2,1]
C0035448
UMLS CUI [2,2]
C0521144
UMLS CUI [3,1]
C4318437
UMLS CUI [3,2]
C0521144
UMLS CUI [4,1]
C0035448
UMLS CUI [4,2]
C0521143
UMLS CUI [5,1]
C4318437
UMLS CUI [5,2]
C0521143
das28 ≤ 5.1
Beskrivning

Disease activity score das28

Datatyp

boolean

Alias
UMLS CUI [1]
C4481729
stable regimen of concomitant ra therapy (nsaids, steroids, non- biological dmards).
Beskrivning

Therapy Stable Rheumatoid Arthritis | NSAIDs | Steroids | Non-Biologic DMARDs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0003873
UMLS CUI [2]
C0003211
UMLS CUI [3]
C0038317
UMLS CUI [4]
C4054347
negative ppd tuberculin skin test
Beskrivning

PPD skin test Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0041290
UMLS CUI [1,2]
C1513916
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous therapy with b or t cell depleting agents other than rituximab (e.g. campath). prior treatment with rituximab, tnf-inhibitors, other biologics (e.g. anti-il-1 therapy) and systemic immunosuppressive agents is allowed with a washout period.
Beskrivning

B-cell depletion therapy | T-cell depletion | Exception Rituximab | Campath | Rituximab With Washout Period allowed | TNF inhibitor With Washout Period allowed | Biological agents With Washout Period allowed | Interleukin-1 Receptor Antagonist With Washout Period allowed | Immunosuppressive Agents Systemic With Washout Period allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C1171324
UMLS CUI [2]
C0677960
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0393022
UMLS CUI [4]
C0939276
UMLS CUI [5,1]
C0393022
UMLS CUI [5,2]
C0332287
UMLS CUI [5,3]
C1710661
UMLS CUI [5,4]
C0683607
UMLS CUI [6,1]
C4521709
UMLS CUI [6,2]
C0332287
UMLS CUI [6,3]
C1710661
UMLS CUI [6,4]
C0683607
UMLS CUI [7,1]
C0005515
UMLS CUI [7,2]
C0332287
UMLS CUI [7,3]
C1710661
UMLS CUI [7,4]
C0683607
UMLS CUI [8,1]
C3536785
UMLS CUI [8,2]
C0332287
UMLS CUI [8,3]
C1710661
UMLS CUI [8,4]
C0683607
UMLS CUI [9,1]
C0021081
UMLS CUI [9,2]
C0205373
UMLS CUI [9,3]
C0332287
UMLS CUI [9,4]
C1710661
UMLS CUI [9,5]
C0683607
any history of ongoing, significant or recurring infections
Beskrivning

Communicable Diseases | Recurrent infections

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0239998
any active inflammatory diseases other than ra
Beskrivning

Inflammatory disorder | Exception Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C1290884
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
treatment with a systemic investigational drug within 6 months prior to screening
Beskrivning

Investigational New Drugs Systemic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205373
women of childbearing potential, unless receiving stable doses of methotrexate or leflunomide
Beskrivning

Childbearing Potential | Exception Methotrexate Dose Stable | Exception Leflunomide Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025677
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0063041
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205360
significant cardiac or pulmonary disease (including methotrexate- associated lung toxicity)
Beskrivning

Heart Disease | Lung disease | Lung Toxicity Associated with Methotrexate

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0024115
UMLS CUI [3,1]
C0024109
UMLS CUI [3,2]
C0600688
UMLS CUI [3,3]
C0332281
UMLS CUI [3,4]
C0025677
hepatic or renal insufficiency
Beskrivning

Hepatic Insufficiency | Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C1565489
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Similar models

Eligibility Rheumatoid Arthritis NCT01023256

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
rheumatoid arthritis (ra) per revised 1987 acr criteria
boolean
C0003873 (UMLS CUI [1])
Rheumatoid Arthritis | Swollen joint count | Tender joint count | Hand joint swollen Quantity | Exception Proximal interphalangeal joint
Item
active ra: ≥3 swollen and 3 tender joints with at least 1 swollen joint in the hand, excluding the pip joint
boolean
C0003873 (UMLS CUI [1])
C0451521 (UMLS CUI [2])
C0451530 (UMLS CUI [3])
C0459470 (UMLS CUI [4,1])
C0038999 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0932508 (UMLS CUI [5,2])
C-reactive protein measurement | Rheumatoid Factor Seronegative | Anti-CCP Seronegative | Rheumatoid Factor Seropositive | Anti-CCP Seropositive
Item
crp > 5.0 mg/l (rf and anti-ccp seronegative); crp >2 mg/l (rf and/or anti-ccp seropositive)
boolean
C0201657 (UMLS CUI [1])
C0035448 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
C4318437 (UMLS CUI [3,1])
C0521144 (UMLS CUI [3,2])
C0035448 (UMLS CUI [4,1])
C0521143 (UMLS CUI [4,2])
C4318437 (UMLS CUI [5,1])
C0521143 (UMLS CUI [5,2])
Disease activity score das28
Item
das28 ≤ 5.1
boolean
C4481729 (UMLS CUI [1])
Therapy Stable Rheumatoid Arthritis | NSAIDs | Steroids | Non-Biologic DMARDs
Item
stable regimen of concomitant ra therapy (nsaids, steroids, non- biological dmards).
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
C4054347 (UMLS CUI [4])
PPD skin test Negative
Item
negative ppd tuberculin skin test
boolean
C0041290 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
B-cell depletion therapy | T-cell depletion | Exception Rituximab | Campath | Rituximab With Washout Period allowed | TNF inhibitor With Washout Period allowed | Biological agents With Washout Period allowed | Interleukin-1 Receptor Antagonist With Washout Period allowed | Immunosuppressive Agents Systemic With Washout Period allowed
Item
previous therapy with b or t cell depleting agents other than rituximab (e.g. campath). prior treatment with rituximab, tnf-inhibitors, other biologics (e.g. anti-il-1 therapy) and systemic immunosuppressive agents is allowed with a washout period.
boolean
C1171324 (UMLS CUI [1])
C0677960 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0393022 (UMLS CUI [3,2])
C0939276 (UMLS CUI [4])
C0393022 (UMLS CUI [5,1])
C0332287 (UMLS CUI [5,2])
C1710661 (UMLS CUI [5,3])
C0683607 (UMLS CUI [5,4])
C4521709 (UMLS CUI [6,1])
C0332287 (UMLS CUI [6,2])
C1710661 (UMLS CUI [6,3])
C0683607 (UMLS CUI [6,4])
C0005515 (UMLS CUI [7,1])
C0332287 (UMLS CUI [7,2])
C1710661 (UMLS CUI [7,3])
C0683607 (UMLS CUI [7,4])
C3536785 (UMLS CUI [8,1])
C0332287 (UMLS CUI [8,2])
C1710661 (UMLS CUI [8,3])
C0683607 (UMLS CUI [8,4])
C0021081 (UMLS CUI [9,1])
C0205373 (UMLS CUI [9,2])
C0332287 (UMLS CUI [9,3])
C1710661 (UMLS CUI [9,4])
C0683607 (UMLS CUI [9,5])
Communicable Diseases | Recurrent infections
Item
any history of ongoing, significant or recurring infections
boolean
C0009450 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
Inflammatory disorder | Exception Rheumatoid Arthritis
Item
any active inflammatory diseases other than ra
boolean
C1290884 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Investigational New Drugs Systemic
Item
treatment with a systemic investigational drug within 6 months prior to screening
boolean
C0013230 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Childbearing Potential | Exception Methotrexate Dose Stable | Exception Leflunomide Dose Stable
Item
women of childbearing potential, unless receiving stable doses of methotrexate or leflunomide
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0063041 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Heart Disease | Lung disease | Lung Toxicity Associated with Methotrexate
Item
significant cardiac or pulmonary disease (including methotrexate- associated lung toxicity)
boolean
C0018799 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0024109 (UMLS CUI [3,1])
C0600688 (UMLS CUI [3,2])
C0332281 (UMLS CUI [3,3])
C0025677 (UMLS CUI [3,4])
Hepatic Insufficiency | Renal Insufficiency
Item
hepatic or renal insufficiency
boolean
C1306571 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
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