ID

22930

Description

A Study to Evaluate Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00299130

Lien

https://clinicaltrials.gov/show/NCT00299130

Mots-clés

Versions (2)
  1. 16/06/2017 16/06/2017 -
  2. 16/06/2017 16/06/2017 -
Téléchargé le

16 juin 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00299130

Anglais

Eligibility Rheumatoid Arthritis NCT00299130

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients 18-80 years of age.
Description

Adult | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
rheumatoid arthritis (ra) for ≥ 6 months, diagnosed according to the revised 1987 american college of rheumatology (acr) criteria for the classification of rheumatoid arthritis.
Description

Rheumatoid Arthritis disease length

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
receiving outpatient treatment for ra.
Description

Outpatient procedure Rheumatoid Arthritis

Type de données

boolean

Alias
UMLS CUI [1,1]
C1299353
UMLS CUI [1,2]
C0003873
swollen joint count (sjc) ≥ 8 (66 joint count), and tender joint count (tjc) ≥ 8 (68 joint count) at screening and baseline.
Description

Swollen joint count | Tender joint count

Type de données

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2]
C0451530
at screening, either
Description

Screening

Type de données

boolean

Alias
UMLS CUI [1]
C1409616
c-reactive protein (crp) ≥ 0.6 mg/dl (6 mg/l), or
Description

C-reactive protein measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201657
erythrocyte sedimentation rate (esr) ≥ 28 mm/hour.
Description

Erythrocyte sedimentation rate measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1176468
inadequate response to methotrexate, having received and tolerated at a dose of 10-25 mg/week it for ≥ 12 weeks.
Description

Methotrexate Dose U/week | Response Inadequate

Type de données

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0560588
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205412
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra.
Description

Autoimmune Disease Rheumatic | Rheumatoid Arthritis | Involvement Systemic Secondary to Rheumatoid Arthritis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C3495832
UMLS CUI [2]
C0003873
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C0175668
UMLS CUI [3,4]
C0003873
inflammatory joint disease other than ra, or other systemic autoimmune disorder.
Description

inflammatory joint disease | Rheumatoid Arthritis | Autoimmune disease (systemic)

Type de données

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2]
C0003873
UMLS CUI [3]
C2895206
diagnosis of juvenile rheumatoid arthritis, or ra before the age of 16.
Description

Juvenile rheumatoid arthritis | Rheumatoid Arthritis Age

Type de données

boolean

Alias
UMLS CUI [1]
C3714757
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0001779
surgery within 12 weeks of study or planned within 24 weeks of randomization.
Description

Operative Surgical Procedures | Operative Surgical Procedures Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1301732
previous treatment with any approved or investigational biological agent for ra, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.
Description

Biological Agents Rheumatoid Arthritis | Biological Agents Investigational Rheumatoid Arthritis | natalizumab | blood cell depletion therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C0003873
UMLS CUI [2,1]
C0005515
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0003873
UMLS CUI [3]
C1172734
UMLS CUI [4]
C0596186
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Similar models

Eligibility Rheumatoid Arthritis NCT00299130

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients 18-80 years of age.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Rheumatoid Arthritis disease length
Item
rheumatoid arthritis (ra) for ≥ 6 months, diagnosed according to the revised 1987 american college of rheumatology (acr) criteria for the classification of rheumatoid arthritis.
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Outpatient procedure Rheumatoid Arthritis
Item
receiving outpatient treatment for ra.
boolean
C1299353 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
Swollen joint count | Tender joint count
Item
swollen joint count (sjc) ≥ 8 (66 joint count), and tender joint count (tjc) ≥ 8 (68 joint count) at screening and baseline.
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
Screening
Item
at screening, either
boolean
C1409616 (UMLS CUI [1])
C-reactive protein measurement
Item
c-reactive protein (crp) ≥ 0.6 mg/dl (6 mg/l), or
boolean
C0201657 (UMLS CUI [1])
Erythrocyte sedimentation rate measurement
Item
erythrocyte sedimentation rate (esr) ≥ 28 mm/hour.
boolean
C1176468 (UMLS CUI [1])
Methotrexate Dose U/week | Response Inadequate
Item
inadequate response to methotrexate, having received and tolerated at a dose of 10-25 mg/week it for ≥ 12 weeks.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0560588 (UMLS CUI [1,3])
C1704632 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease Rheumatic | Rheumatoid Arthritis | Involvement Systemic Secondary to Rheumatoid Arthritis
Item
rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra.
boolean
C0004364 (UMLS CUI [1,1])
C3495832 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2])
C1314939 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0175668 (UMLS CUI [3,3])
C0003873 (UMLS CUI [3,4])
inflammatory joint disease | Rheumatoid Arthritis | Autoimmune disease (systemic)
Item
inflammatory joint disease other than ra, or other systemic autoimmune disorder.
boolean
C0683381 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C2895206 (UMLS CUI [3])
Juvenile rheumatoid arthritis | Rheumatoid Arthritis Age
Item
diagnosis of juvenile rheumatoid arthritis, or ra before the age of 16.
boolean
C3714757 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
Operative Surgical Procedures | Operative Surgical Procedures Planned
Item
surgery within 12 weeks of study or planned within 24 weeks of randomization.
boolean
C0543467 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Biological Agents Rheumatoid Arthritis | Biological Agents Investigational Rheumatoid Arthritis | natalizumab | blood cell depletion therapy
Item
previous treatment with any approved or investigational biological agent for ra, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.
boolean
C0005515 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0005515 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0003873 (UMLS CUI [2,3])
C1172734 (UMLS CUI [3])
C0596186 (UMLS CUI [4])
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