ID

31904

Beschreibung

A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00993317

Link

https://clinicaltrials.gov/show/NCT00993317

Stichworte

Versionen (1)
  1. 08.10.18 08.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. Oktober 2018

DOI

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Eligibility Rheumatoid Arthritis NCT00993317

Englisch

Eligibility Rheumatoid Arthritis NCT00993317

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult-onset ra of at least 6 months but not longer than 15 years in duration as defined by the 1987 american college of rheumatology classification criteria
Beschreibung

Adult onset Rheumatoid Arthritis Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1853562
UMLS CUI [1,2]
C0003873
UMLS CUI [1,3]
C0449238
active ra disease as defined by at least 9 tender joints and 9 swollen joints, esr of 30 mm/hour or crp of 1.5 mg/dl
Beschreibung

Rheumatoid Arthritis | Tender joint count | Swollen joint count | Erythrocyte sedimentation rate measurement | C-reactive protein measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0451530
UMLS CUI [3]
C0451521
UMLS CUI [4]
C1176468
UMLS CUI [5]
C0201657
mtx (with or without folic acid) for at least 24 weeks prior to the baseline visit, the dose of mtx and route of administration must have been stable for at least 8 weeks prior to the baseline visit. the minimum stable dose of mtx allowed is 10 mg weekly.
Beschreibung

Methotrexate Dose Stable U/week | Methotrexate Route of Administration Stable | Folic Acid

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0013153
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0016410
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
Beschreibung

Arthritis Other | Arthritis, Psoriatic | Ankylosing spondylitis | Arthritis, Reactive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0003872
UMLS CUI [3]
C0038013
UMLS CUI [4]
C0085435
secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
Beschreibung

Arthritis Secondary Noninflammatory | Osteoarthritis | Fibromyalgia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0442743
UMLS CUI [2]
C0029408
UMLS CUI [3]
C0016053
nyha (new york heart association) class iii or iv congestive heart failure
Beschreibung

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
current or history of, tuberculosis
Beschreibung

Tuberculosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0041296
history of chronic infection, recent serious or life-threatening infection (within 24 weeks , including herpes zoster), or any current sign or symptom that may indicate an infection (e.g., fever, cough)
Beschreibung

Chronic infectious disease | Communicable Disease Serious | Communicable Disease Life Threatening | Herpes zoster | Sign or Symptom Communicable Disease | Fever | Cough

Datentyp

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C2826244
UMLS CUI [4]
C0019360
UMLS CUI [5,1]
C3540840
UMLS CUI [5,2]
C0009450
UMLS CUI [6]
C0015967
UMLS CUI [7]
C0010200
high risk of infection
Beschreibung

High risk of Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0009450
have received any experimental non-biological therapy, within or outside a clinical trial in the 12 weeks prior to baseline
Beschreibung

Therapy, Investigational | Exception Biological treatment | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1531518
UMLS CUI [3]
C2348568
have received previous b-cell therapy (eg. rituximab)
Beschreibung

B cell therapy | rituximab

Datentyp

boolean

Alias
UMLS CUI [1]
C0545321
UMLS CUI [2]
C0393022
have received any other biological therapy for ra within 24 weeks prior to baseline visit, except for etanercept where a three month washout prior to baseline visit is acceptable
Beschreibung

Biological treatment Rheumatoid Arthritis | Exception Etanercept Associated with Washout Period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1531518
UMLS CUI [1,2]
C0003873
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0717758
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C1710661
have received previous treatment with a biological therapy for ra that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
Beschreibung

Biological treatment Rheumatoid Arthritis | Result Severe allergic reaction | Result Anaphylaxis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1531518
UMLS CUI [1,2]
C0003873
UMLS CUI [2,1]
C1274040
UMLS CUI [2,2]
C2220378
UMLS CUI [3,1]
C1274040
UMLS CUI [3,2]
C0002792
failed to respond to previous treatment with an anti-tnf drug
Beschreibung

Anti-TNF drug Unresponsive to Treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1562242
UMLS CUI [1,2]
C0205269
female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug
Beschreibung

Breast Feeding | Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00993317

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult onset Rheumatoid Arthritis Duration
Item
adult-onset ra of at least 6 months but not longer than 15 years in duration as defined by the 1987 american college of rheumatology classification criteria
boolean
C1853562 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Rheumatoid Arthritis | Tender joint count | Swollen joint count | Erythrocyte sedimentation rate measurement | C-reactive protein measurement
Item
active ra disease as defined by at least 9 tender joints and 9 swollen joints, esr of 30 mm/hour or crp of 1.5 mg/dl
boolean
C0003873 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
C1176468 (UMLS CUI [4])
C0201657 (UMLS CUI [5])
Methotrexate Dose Stable U/week | Methotrexate Route of Administration Stable | Folic Acid
Item
mtx (with or without folic acid) for at least 24 weeks prior to the baseline visit, the dose of mtx and route of administration must have been stable for at least 8 weeks prior to the baseline visit. the minimum stable dose of mtx allowed is 10 mg weekly.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
C0025677 (UMLS CUI [2,1])
C0013153 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0016410 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Arthritis Other | Arthritis, Psoriatic | Ankylosing spondylitis | Arthritis, Reactive
Item
any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
boolean
C0003864 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0003872 (UMLS CUI [2])
C0038013 (UMLS CUI [3])
C0085435 (UMLS CUI [4])
Arthritis Secondary Noninflammatory | Osteoarthritis | Fibromyalgia
Item
secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
boolean
C0003864 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0442743 (UMLS CUI [1,3])
C0029408 (UMLS CUI [2])
C0016053 (UMLS CUI [3])
Congestive heart failure New York Heart Association Classification
Item
nyha (new york heart association) class iii or iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Tuberculosis
Item
current or history of, tuberculosis
boolean
C0041296 (UMLS CUI [1])
Chronic infectious disease | Communicable Disease Serious | Communicable Disease Life Threatening | Herpes zoster | Sign or Symptom Communicable Disease | Fever | Cough
Item
history of chronic infection, recent serious or life-threatening infection (within 24 weeks , including herpes zoster), or any current sign or symptom that may indicate an infection (e.g., fever, cough)
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
C0019360 (UMLS CUI [4])
C3540840 (UMLS CUI [5,1])
C0009450 (UMLS CUI [5,2])
C0015967 (UMLS CUI [6])
C0010200 (UMLS CUI [7])
High risk of Communicable Disease
Item
high risk of infection
boolean
C0332167 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
Therapy, Investigational | Exception Biological treatment | Study Subject Participation Status
Item
have received any experimental non-biological therapy, within or outside a clinical trial in the 12 weeks prior to baseline
boolean
C0949266 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1531518 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3])
B cell therapy | rituximab
Item
have received previous b-cell therapy (eg. rituximab)
boolean
C0545321 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
Biological treatment Rheumatoid Arthritis | Exception Etanercept Associated with Washout Period
Item
have received any other biological therapy for ra within 24 weeks prior to baseline visit, except for etanercept where a three month washout prior to baseline visit is acceptable
boolean
C1531518 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0717758 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C1710661 (UMLS CUI [2,4])
Biological treatment Rheumatoid Arthritis | Result Severe allergic reaction | Result Anaphylaxis
Item
have received previous treatment with a biological therapy for ra that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
boolean
C1531518 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C2220378 (UMLS CUI [2,2])
C1274040 (UMLS CUI [3,1])
C0002792 (UMLS CUI [3,2])
Anti-TNF drug Unresponsive to Treatment
Item
failed to respond to previous treatment with an anti-tnf drug
boolean
C1562242 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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