ID

39176

Beschreibung

Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA); ODM derived from: https://clinicaltrials.gov/show/NCT01185301

Link

https://clinicaltrials.gov/show/NCT01185301

Stichworte

Versionen (1)
  1. 08.12.19 08.12.19 -
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See clinicaltrials.gov

Hochgeladen am

8. Dezember 2019

DOI

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Eligibility Early Rheumatoid Arthritis NCT01185301

Englisch

Eligibility Early Rheumatoid Arthritis NCT01185301

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects at least 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
subject has a diagnosis of rheumatoid arthritis (ra) as defined by either the 1987-revised american college of rheumatology (acr) classification criteria or the new acr/ european league against rheumatism (eular) diagnostic criteria for ra 2010 and has a disease duration of less than 1 year from diagnosis by a licensed health care provider
Beschreibung

Rheumatoid Arthritis Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
subject must meet the following criteria:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. disease activity score of c-reactive protein (das28[crp]) ≥ 3.2 (at the baseline visit only)
Beschreibung

C-reactive protein Disease activity score DAS28

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006560
UMLS CUI [1,2]
C4481729
2. at least 6 swollen joints out of 66 assessed (at the screening and baseline visits)
Beschreibung

Swollen joint count

Datentyp

boolean

Alias
UMLS CUI [1]
C0451521
3. at least 8 tender joints out of 68 assessed (at the screening and baseline visits)
Beschreibung

Tender joint count

Datentyp

boolean

Alias
UMLS CUI [1]
C0451530
4. c-reactive protein (crp) ≥ 1.5 mg/dl (at the screening visit only), or erythrocyte sedimentation rate (esr) ≥ 28 mm/1h (at the screening and baseline visits)
Beschreibung

C-reactive protein measurement | Erythrocyte sedimentation rate measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201657
UMLS CUI [2]
C1176468
5. fulfill at least one of the following three criteria: rheumatoid factor (rf) positive, have at least 1 bony erosion, anti-cyclic citrullinated peptide (anti-ccp) antibody positive
Beschreibung

Criteria Fulfill Quantity | Rheumatoid factor positive | Bone erosion Quantity | Anti-cyclic citrullinated peptide antibody positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0151379
UMLS CUI [3,1]
C0587240
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C2609056
subject is judged to be in good health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (cxr), and a 12-lead electrocardiogram (ecg) performed during screening
Beschreibung

Study Subject Good health Medical History | Study Subject Good health Profile | Study Subject Good health Physical Examination | Study Subject Good health Chest X-ray | Study Subject Good health 12 lead ECG

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C3813622
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C3813622
UMLS CUI [2,3]
C1979963
UMLS CUI [3,1]
C0681850
UMLS CUI [3,2]
C3813622
UMLS CUI [3,3]
C0031809
UMLS CUI [4,1]
C0681850
UMLS CUI [4,2]
C3813622
UMLS CUI [4,3]
C0039985
UMLS CUI [5,1]
C0681850
UMLS CUI [5,2]
C3813622
UMLS CUI [5,3]
C0430456
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has previous exposure to any systemic biologic therapy including adalimumab
Beschreibung

Exposure to Biological treatment Systemic | adalimumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1531518
UMLS CUI [1,3]
C0205373
UMLS CUI [2]
C1122087
subject has been previously treated with greater than 1 disease modifying antirheumatic drugs (dmards) or with methotrexate (mtx)
Beschreibung

Disease-Modifying Antirheumatic Drugs Quantity | Methotrexate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0025677
subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study)
Beschreibung

Operation on joint | Clinical Trial Assessment Joints

Datentyp

boolean

Alias
UMLS CUI [1]
C0185132
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0022417
subject has chronic arthritis diagnosed before age 17 years
Beschreibung

Chronic arthritis | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0263680
UMLS CUI [2]
C0001779
history of invasive infection (e.g., listeriosis and histoplasmosis), chronic or active hepatitis c infection, human immunodeficiency virus (hiv) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (tb)
Beschreibung

Communicable Disease Invasive | Listeriosis | Histoplasmosis | Hepatitis C, Chronic | Hepatitis C | HIV Infection | Immunologic Deficiency Syndromes | Recurrent infections chronic | Tuberculosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205281
UMLS CUI [2]
C0023860
UMLS CUI [3]
C0019655
UMLS CUI [4]
C0524910
UMLS CUI [5]
C0019196
UMLS CUI [6]
C0019693
UMLS CUI [7]
C0021051
UMLS CUI [8,1]
C0239998
UMLS CUI [8,2]
C0205191
UMLS CUI [9]
C0041296
hepatitis b virus: hepatitis b surface antigen (hbs ag) positive (+) or detected sensitivity on the hepatitis b virus dna (hbv dna) polymerase chain reaction (pcr) qualitative test
Beschreibung

Hepatitis B Virus | Hepatitis B surface antigen positive | Hepatitis B DNA detectable Polymerase chain reaction test

Datentyp

boolean

Alias
UMLS CUI [1]
C0019169
UMLS CUI [2]
C0149709
UMLS CUI [3,1]
C1096264
UMLS CUI [3,2]
C1658604
infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days prior to the baseline visit or oral anti-infectives within 14 days prior to the baseline visit
Beschreibung

Communicable Diseases Requirement Anti-Infective Agents Intravenous | Communicable Diseases Requirement Anti-Infective Agents Oral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003204
UMLS CUI [1,4]
C1522726
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003204
UMLS CUI [2,4]
C1527415
female subject who is pregnant or breast-feeding or considering becoming pregnant
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

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

Eligibility Early Rheumatoid Arthritis NCT01185301

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female subjects at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis Disease length
Item
subject has a diagnosis of rheumatoid arthritis (ra) as defined by either the 1987-revised american college of rheumatology (acr) classification criteria or the new acr/ european league against rheumatism (eular) diagnostic criteria for ra 2010 and has a disease duration of less than 1 year from diagnosis by a licensed health care provider
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Criteria Fulfill
Item
subject must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C-reactive protein Disease activity score DAS28
Item
1. disease activity score of c-reactive protein (das28[crp]) ≥ 3.2 (at the baseline visit only)
boolean
C0006560 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
Swollen joint count
Item
2. at least 6 swollen joints out of 66 assessed (at the screening and baseline visits)
boolean
C0451521 (UMLS CUI [1])
Tender joint count
Item
3. at least 8 tender joints out of 68 assessed (at the screening and baseline visits)
boolean
C0451530 (UMLS CUI [1])
C-reactive protein measurement | Erythrocyte sedimentation rate measurement
Item
4. c-reactive protein (crp) ≥ 1.5 mg/dl (at the screening visit only), or erythrocyte sedimentation rate (esr) ≥ 28 mm/1h (at the screening and baseline visits)
boolean
C0201657 (UMLS CUI [1])
C1176468 (UMLS CUI [2])
Criteria Fulfill Quantity | Rheumatoid factor positive | Bone erosion Quantity | Anti-cyclic citrullinated peptide antibody positive
Item
5. fulfill at least one of the following three criteria: rheumatoid factor (rf) positive, have at least 1 bony erosion, anti-cyclic citrullinated peptide (anti-ccp) antibody positive
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0151379 (UMLS CUI [2])
C0587240 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C2609056 (UMLS CUI [4])
Study Subject Good health Medical History | Study Subject Good health Profile | Study Subject Good health Physical Examination | Study Subject Good health Chest X-ray | Study Subject Good health 12 lead ECG
Item
subject is judged to be in good health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (cxr), and a 12-lead electrocardiogram (ecg) performed during screening
boolean
C0681850 (UMLS CUI [1,1])
C3813622 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2,1])
C3813622 (UMLS CUI [2,2])
C1979963 (UMLS CUI [2,3])
C0681850 (UMLS CUI [3,1])
C3813622 (UMLS CUI [3,2])
C0031809 (UMLS CUI [3,3])
C0681850 (UMLS CUI [4,1])
C3813622 (UMLS CUI [4,2])
C0039985 (UMLS CUI [4,3])
C0681850 (UMLS CUI [5,1])
C3813622 (UMLS CUI [5,2])
C0430456 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Exposure to Biological treatment Systemic | adalimumab
Item
subject has previous exposure to any systemic biologic therapy including adalimumab
boolean
C0332157 (UMLS CUI [1,1])
C1531518 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C1122087 (UMLS CUI [2])
Disease-Modifying Antirheumatic Drugs Quantity | Methotrexate
Item
subject has been previously treated with greater than 1 disease modifying antirheumatic drugs (dmards) or with methotrexate (mtx)
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2])
Operation on joint | Clinical Trial Assessment Joints
Item
subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study)
boolean
C0185132 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
Chronic arthritis | Age
Item
subject has chronic arthritis diagnosed before age 17 years
boolean
C0263680 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Communicable Disease Invasive | Listeriosis | Histoplasmosis | Hepatitis C, Chronic | Hepatitis C | HIV Infection | Immunologic Deficiency Syndromes | Recurrent infections chronic | Tuberculosis
Item
history of invasive infection (e.g., listeriosis and histoplasmosis), chronic or active hepatitis c infection, human immunodeficiency virus (hiv) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (tb)
boolean
C0009450 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0023860 (UMLS CUI [2])
C0019655 (UMLS CUI [3])
C0524910 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
C0019693 (UMLS CUI [6])
C0021051 (UMLS CUI [7])
C0239998 (UMLS CUI [8,1])
C0205191 (UMLS CUI [8,2])
C0041296 (UMLS CUI [9])
Hepatitis B Virus | Hepatitis B surface antigen positive | Hepatitis B DNA detectable Polymerase chain reaction test
Item
hepatitis b virus: hepatitis b surface antigen (hbs ag) positive (+) or detected sensitivity on the hepatitis b virus dna (hbv dna) polymerase chain reaction (pcr) qualitative test
boolean
C0019169 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1096264 (UMLS CUI [3,1])
C1658604 (UMLS CUI [3,2])
Communicable Diseases Requirement Anti-Infective Agents Intravenous | Communicable Diseases Requirement Anti-Infective Agents Oral
Item
infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days prior to the baseline visit or oral anti-infectives within 14 days prior to the baseline visit
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003204 (UMLS CUI [1,3])
C1522726 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003204 (UMLS CUI [2,3])
C1527415 (UMLS CUI [2,4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
female subject who is pregnant or breast-feeding or considering becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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