ID

22969

Description

A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA); ODM derived from: https://clinicaltrials.gov/show/NCT00422942

Link

https://clinicaltrials.gov/show/NCT00422942

Keywords

  1. 6/19/17 6/19/17 -
Uploaded on

June 19, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00422942

Eligibility Rheumatoid Arthritis NCT00422942

Inclusion Criteria
Description

Inclusion Criteria

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

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
ra for >=3 months;
Description

Rheumatoid Arthritis disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
receiving outpatient treatment;
Description

Outpatient procedure

Data type

boolean

Alias
UMLS CUI [1]
C1299353
failed treatment with >=1 dmard (but not anti tnf or other biologic therapy);
Description

Disease-Modifying Antirheumatic Drugs Quantity failed | Anti-TNF drug Absent | Biological treatment Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C1562242
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1531518
UMLS CUI [3,2]
C0332197
inadequate response to methotrexate, having taken and tolerated it for >=12 weeks, with a stable dose for >=4 weeks.
Description

Methotrexate Dose Stable | Response Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
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

Data type

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
history of, or current, inflammatory joint disease other than ra, or other systemic autoimmune disorder;
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2]
C0003873
UMLS CUI [3]
C2895206
diagnosis of ra before the age of 16;
Description

Rheumatoid Arthritis | Age

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0001779
bone/joint surgery within 12 weeks of study;
Description

Bone Operative Surgical Procedures | Operation on joint

Data type

boolean

Alias
UMLS CUI [1,1]
C0262950
UMLS CUI [1,2]
C0543467
UMLS CUI [2]
C0185132
prior use of anti-tnf or other biologic therapy, an anti-alpha 4 integrin, or any cell-depleting therapies.
Description

Anti-TNF drug | Biological treatment | natalizumab | blood cell depletion therapy

Data type

boolean

Alias
UMLS CUI [1]
C1562242
UMLS CUI [2]
C1531518
UMLS CUI [3]
C1172734
UMLS CUI [4]
C0596186

Similar models

Eligibility Rheumatoid Arthritis NCT00422942

Name
Type
Description | Question | Decode (Coded Value)
Data type
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
ra for >=3 months;
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Outpatient procedure
Item
receiving outpatient treatment;
boolean
C1299353 (UMLS CUI [1])
Disease-Modifying Antirheumatic Drugs Quantity failed | Anti-TNF drug Absent | Biological treatment Absent
Item
failed treatment with >=1 dmard (but not anti tnf or other biologic therapy);
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1562242 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1531518 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Methotrexate Dose Stable | Response Inadequate
Item
inadequate response to methotrexate, having taken and tolerated it for >=12 weeks, with a stable dose for >=4 weeks.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (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
history of, or current, inflammatory joint disease other than ra, or other systemic autoimmune disorder;
boolean
C0683381 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C2895206 (UMLS CUI [3])
Rheumatoid Arthritis | Age
Item
diagnosis of ra before the age of 16;
boolean
C0003873 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Bone Operative Surgical Procedures | Operation on joint
Item
bone/joint surgery within 12 weeks of study;
boolean
C0262950 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0185132 (UMLS CUI [2])
Anti-TNF drug | Biological treatment | natalizumab | blood cell depletion therapy
Item
prior use of anti-tnf or other biologic therapy, an anti-alpha 4 integrin, or any cell-depleting therapies.
boolean
C1562242 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C1172734 (UMLS CUI [3])
C0596186 (UMLS CUI [4])

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