ID
40152
Description
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid
Keywords
Versions (1)
- 3/17/20 3/17/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 17, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455
Screen - Biomarker Samples; Diagnosis/ History of Rheumatoid Arthritis; Prior Methotrexate Treatment; Prior RA Medications; Screen Failure
Description
Diagnosis/ History of Rheumatoid Arthritis
Alias
- UMLS CUI-1
- C0003873
- UMLS CUI-2
- C0011900
- UMLS CUI-3
- C0262926
Description
Indicate Pain diagnosis
Data type
text
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0011900
Description
Disease onset date
Data type
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Description
Functional class pertaining to subject?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0003873
- UMLS CUI [1,2]
- C0598463
- UMLS CUI [1,3]
- C0456387
Description
Prior Methotrexate Treatment
Alias
- UMLS CUI-1
- C1514463
- UMLS CUI-2
- C0025677
Description
Category for medication code - Prior Methotrexate Treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0009219
- UMLS CUI [1,3]
- C0683312
- UMLS CUI [2,1]
- C1514463
- UMLS CUI [2,2]
- C0025677
Description
Medication Type - Prior Methotrexate Treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [2,1]
- C1514463
- UMLS CUI [2,2]
- C0025677
Description
Prior Methotrexate Treatment
Alias
- UMLS CUI-1
- C1514463
- UMLS CUI-2
- C0025677
Description
Prior Methotrexate Treatment - Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0025677
- UMLS CUI [2]
- C2348184
Description
Prior Methotrexate Treatment - Drug Name
Data type
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0025677
- UMLS CUI [2]
- C2360065
Description
Prior Methotrexate Treatment - Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0025677
- UMLS CUI [2]
- C0808070
Description
Please insert reason for failing methotrexate
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0025677
- UMLS CUI [2]
- C0549178
Description
Prior Methotrexate Treatment - End Date if not ongoing
Data type
date
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0025677
- UMLS CUI [2]
- C0806020
Description
Prior Methotrexate Treatment - Unit Dose
Data type
float
Measurement units
- mg/week
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0025677
- UMLS CUI [2]
- C0869039
Description
Prior Methotrexate Treatment - Units
Data type
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0025677
- UMLS CUI [2]
- C1519795
Description
Prior Methotrexate Treatment - Frequency
Data type
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0025677
- UMLS CUI [2]
- C3476109
Description
Prior Methotrexate Treatment - Route
Data type
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0025677
- UMLS CUI [2]
- C0013153
Description
Primary reason for failing methotrexate
Data type
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0025677
- UMLS CUI [2,1]
- C0025677
- UMLS CUI [2,2]
- C0231175
- UMLS CUI [2,3]
- C0392360
Description
Prior Methotrexate Treatment - If other reason for failing methotrexate, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0025677
- UMLS CUI [2,1]
- C0025677
- UMLS CUI [2,2]
- C0231175
- UMLS CUI [2,3]
- C0392360
- UMLS CUI [3,1]
- C0205394
- UMLS CUI [3,2]
- C2348235
Description
Prior RA Medications
Alias
- UMLS CUI-1
- C1514463
- UMLS CUI-2
- C0003873
Description
Category for medication code - Prior RA Medications
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0009219
- UMLS CUI [1,3]
- C0683312
- UMLS CUI [2,1]
- C1514463
- UMLS CUI [2,2]
- C0003873
Description
Medication Type - Prior RA Medications
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [2,1]
- C1514463
- UMLS CUI [2,2]
- C0003873
Description
Prior RA Medications
Alias
- UMLS CUI-1
- C1514463
- UMLS CUI-2
- C0003873
Description
Prior RA Medications - Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0003873
- UMLS CUI [2]
- C2348184
Description
Prior RA Medications - Drug Name
Data type
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0003873
- UMLS CUI [2]
- C2360065
Description
Primary reason medication stopped - Prior RA Medications
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1444662
- UMLS CUI [2,1]
- C1514463
- UMLS CUI [2,2]
- C0003873
Description
If other reason for medication stopped, specify - Prior RA Medications
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1444662
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C2348235
- UMLS CUI [3,1]
- C1514463
- UMLS CUI [3,2]
- C0003873
Description
Screen Failure
Alias
- UMLS CUI-1
- C1710476
Description
Was this subject a screen failure?
Data type
boolean
Alias
- UMLS CUI [1]
- C1710476
Description
Screen failure date
Data type
date
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0011008
Description
Reason for screen failure
Data type
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Similar models
Screen - Biomarker Samples; Diagnosis/ History of Rheumatoid Arthritis; Prior Methotrexate Treatment; Prior RA Medications; Screen Failure
C0005516 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0005516 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0011900 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0011900 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C0025677 (UMLS CUI-2)
C0009219 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
C0332307 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
C0025677 (UMLS CUI-2)
C0025677 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
C0025677 (UMLS CUI [1,2])
C2360065 (UMLS CUI [2])
C0025677 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2])
C0025677 (UMLS CUI [1,2])
C0549178 (UMLS CUI [2])
C0025677 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2])
C0025677 (UMLS CUI [1,2])
C0869039 (UMLS CUI [2])
C0025677 (UMLS CUI [1,2])
C1519795 (UMLS CUI [2])
C0025677 (UMLS CUI [1,2])
C3476109 (UMLS CUI [2])
C0025677 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2])
C0025677 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
C0025677 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
C0009219 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0332307 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0003873 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
C0003873 (UMLS CUI [1,2])
C2360065 (UMLS CUI [2])
C0013227 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0013227 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])
C0011008 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])