ID

40152

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2020-03-17 2020-03-17 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 mars 2020

DOI

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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

Engelsk

Screen - Biomarker Samples; Diagnosis/ History of Rheumatoid Arthritis; Prior Methotrexate Treatment; Prior RA Medications; Screen Failure

1 Formulär  
Biomarker Samples
Beskrivning

Biomarker Samples

Alias
UMLS CUI-1
C0005516
UMLS CUI-2
C0370003
Has sample been collected?
Beskrivning

Has sample been collected?

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Beskrivning

Date sample taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
If sample has not been collected, provide reason
Beskrivning

If sample has not been collected, provide reason

Datatyp

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0005516
UMLS CUI [1,3]
C2826287
If other reason for sample has not been collected, specify
Beskrivning

If other reason for sample has not been collected, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0005516
UMLS CUI [1,3]
C2826287
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Sample Type
Beskrivning

Sample Type

Datatyp

text

Alias
UMLS CUI [1]
C2347029
Sample Number
Beskrivning

Sample Number

Datatyp

text

Alias
UMLS CUI [1]
C1299222
Diagnosis/ History of Rheumatoid Arthritis
Beskrivning

Diagnosis/ History of Rheumatoid Arthritis

Alias
UMLS CUI-1
C0003873
UMLS CUI-2
C0011900
UMLS CUI-3
C0262926
Indicate Pain diagnosis
Beskrivning

Indicate Pain diagnosis

Datatyp

text

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0011900
Disease onset date
Beskrivning

Disease onset date

Datatyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Functional class pertaining to subject?
Beskrivning

Functional class pertaining to subject?

Datatyp

integer

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
Prior Methotrexate Treatment
Beskrivning

Prior Methotrexate Treatment

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0025677
Category for medication code - Prior Methotrexate Treatment
Beskrivning

Category for medication code - Prior Methotrexate Treatment

Datatyp

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
Medication Type - Prior Methotrexate Treatment
Beskrivning

Medication Type - Prior Methotrexate Treatment

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0025677
Prior Methotrexate Treatment
Beskrivning

Prior Methotrexate Treatment

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0025677
Prior Methotrexate Treatment - Sequence Number
Beskrivning

Prior Methotrexate Treatment - Sequence Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0025677
UMLS CUI [2]
C2348184
Prior Methotrexate Treatment - Drug Name
Beskrivning

Prior Methotrexate Treatment - Drug Name

Datatyp

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0025677
UMLS CUI [2]
C2360065
Prior Methotrexate Treatment - Start Date
Beskrivning

Prior Methotrexate Treatment - Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0025677
UMLS CUI [2]
C0808070
Prior Methotrexate Treatment - Ongoing?
Beskrivning

Please insert reason for failing methotrexate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0025677
UMLS CUI [2]
C0549178
Prior Methotrexate Treatment - End Date if not ongoing
Beskrivning

Prior Methotrexate Treatment - End Date if not ongoing

Datatyp

date

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0025677
UMLS CUI [2]
C0806020
Prior Methotrexate Treatment - Unit Dose
Beskrivning

Prior Methotrexate Treatment - Unit Dose

Datatyp

float

Måttenheter
  • mg/week
Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0025677
UMLS CUI [2]
C0869039
mg/week
Prior Methotrexate Treatment - Units
Beskrivning

Prior Methotrexate Treatment - Units

Datatyp

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0025677
UMLS CUI [2]
C1519795
Prior Methotrexate Treatment - Frequency
Beskrivning

Prior Methotrexate Treatment - Frequency

Datatyp

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0025677
UMLS CUI [2]
C3476109
Prior Methotrexate Treatment - Route
Beskrivning

Prior Methotrexate Treatment - Route

Datatyp

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0025677
UMLS CUI [2]
C0013153
Prior Methotrexate Treatment - Primary reason for failing methotrexate
Beskrivning

Primary reason for failing methotrexate

Datatyp

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
Prior Methotrexate Treatment - If other reason for failing methotrexate, specify
Beskrivning

Prior Methotrexate Treatment - If other reason for failing methotrexate, specify

Datatyp

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
Prior RA Medications
Beskrivning

Prior RA Medications

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0003873
Category for medication code - Prior RA Medications
Beskrivning

Category for medication code - Prior RA Medications

Datatyp

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
Medication Type - Prior RA Medications
Beskrivning

Medication Type - Prior RA Medications

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0003873
Prior RA Medications
Beskrivning

Prior RA Medications

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0003873
Prior RA Medications - Sequence Number
Beskrivning

Prior RA Medications - Sequence Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0003873
UMLS CUI [2]
C2348184
Prior RA Medications - Drug Name
Beskrivning

Prior RA Medications - Drug Name

Datatyp

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0003873
UMLS CUI [2]
C2360065
Primary reason medication stopped - Prior RA Medications
Beskrivning

Primary reason medication stopped - Prior RA Medications

Datatyp

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
If other reason for medication stopped, specify - Prior RA Medications
Beskrivning

If other reason for medication stopped, specify - Prior RA Medications

Datatyp

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
Screen Failure
Beskrivning

Screen Failure

Alias
UMLS CUI-1
C1710476
Was this subject a screen failure?
Beskrivning

Was this subject a screen failure?

Datatyp

boolean

Alias
UMLS CUI [1]
C1710476
Screen failure date
Beskrivning

Screen failure date

Datatyp

date

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0011008
Reason for screen failure
Beskrivning

Reason for screen failure

Datatyp

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
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Similar models

Screen - Biomarker Samples; Diagnosis/ History of Rheumatoid Arthritis; Prior Methotrexate Treatment; Prior RA Medications; Screen Failure

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Biomarker Samples
C0005516 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
Has sample been collected?
Item
Has sample been collected?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
If sample has not been collected, provide reason
text
C0200345 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
If sample has not been collected, provide reason
Code List
If sample has not been collected, provide reason
CL Item
Subject not asked by investigator (2)
CL Item
Other, specify (OT)
If other reason for sample has not been collected, specify
Item
If other reason for sample has not been collected, specify
text
C0200345 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Sample Type
Item
Sample Type
text
C2347029 (UMLS CUI [1])
Sample Number
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Item Group
Diagnosis/ History of Rheumatoid Arthritis
C0003873 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
Indicate Pain diagnosis
Item
Indicate Pain diagnosis
text
C0030193 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Disease onset date
Item
Disease onset date
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Functional class pertaining to subject?
integer
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Functional class pertaining to subject?
Code List
Functional class pertaining to subject?
CL Item
Class I - Completely able to perform usual activities of daily living (1)
CL Item
Class II- Able to perform self-care & vocational activities, limited avocational (2)
CL Item
Class III-Able to perform self-care activities, limited vocational & avocational (3)
CL Item
Class IV-Limited ability to perform self-care vocational &avocational activities (4)
Item Group
Prior Methotrexate Treatment
C1514463 (UMLS CUI-1)
C0025677 (UMLS CUI-2)
Category for medication code - Prior Methotrexate Treatment
Item
Category for medication code - Prior Methotrexate Treatment
text
C0013227 (UMLS CUI [1,1])
C0009219 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
Medication Type - Prior Methotrexate Treatment
Item
Medication Type - Prior Methotrexate Treatment
text
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
Item Group
Prior Methotrexate Treatment
C1514463 (UMLS CUI-1)
C0025677 (UMLS CUI-2)
Prior Methotrexate Treatment - Sequence Number
Item
Prior Methotrexate Treatment - Sequence Number
integer
C1514463 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
Prior Methotrexate Treatment - Drug Name
Item
Prior Methotrexate Treatment - Drug Name
text
C1514463 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C2360065 (UMLS CUI [2])
Prior Methotrexate Treatment - Start Date
Item
Prior Methotrexate Treatment - Start Date
date
C1514463 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2])
Prior Methotrexate Treatment - Ongoing?
Item
Prior Methotrexate Treatment - Ongoing?
boolean
C1514463 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0549178 (UMLS CUI [2])
Prior Methotrexate Treatment - End Date if not ongoing
Item
Prior Methotrexate Treatment - End Date if not ongoing
date
C1514463 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2])
Prior Methotrexate Treatment - Unit Dose
Item
Prior Methotrexate Treatment - Unit Dose
float
C1514463 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0869039 (UMLS CUI [2])
Prior Methotrexate Treatment - Units
Item
Prior Methotrexate Treatment - Units
text
C1514463 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C1519795 (UMLS CUI [2])
Prior Methotrexate Treatment - Frequency
Item
Prior Methotrexate Treatment - Frequency
text
C1514463 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C3476109 (UMLS CUI [2])
Item
Prior Methotrexate Treatment - Route
text
C1514463 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2])
Prior Methotrexate Treatment - Route
Code List
Prior Methotrexate Treatment - Route
CL Item
Intravenous  (IV)
CL Item
Subcutaneous  (SC)
CL Item
Oral  (PO)
CL Item
Intramuscular (IM)
Item
Prior Methotrexate Treatment - Primary reason for failing methotrexate
text
C1514463 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
Prior Methotrexate Treatment - Primary reason for failing methotrexate
Code List
Prior Methotrexate Treatment - Primary reason for failing methotrexate
CL Item
Lack of efficacy  (11)
CL Item
Non-treatment related Adverse Event  (14)
CL Item
Treatment related toxicity/treatment not tolerated (15)
CL Item
Subject no longer wanted treatment  (17)
CL Item
Unknown (18)
CL Item
If reason for failing methotrexate is other, specify (?)
Prior Methotrexate Treatment - If other reason for failing methotrexate, specify
Item
Prior Methotrexate Treatment - If other reason for failing methotrexate, specify
text
C1514463 (UMLS CUI [1,1])
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])
Item Group
Prior RA Medications
C1514463 (UMLS CUI-1)
C0003873 (UMLS CUI-2)
Category for medication code - Prior RA Medications
Item
Category for medication code - Prior RA Medications
text
C0013227 (UMLS CUI [1,1])
C0009219 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Medication Type - Prior RA Medications
Item
Medication Type - Prior RA Medications
text
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Item Group
Prior RA Medications
C1514463 (UMLS CUI-1)
C0003873 (UMLS CUI-2)
Prior RA Medications - Sequence Number
Item
Prior RA Medications - Sequence Number
integer
C1514463 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
Prior RA Medications - Drug Name
Item
Prior RA Medications - Drug Name
text
C1514463 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C2360065 (UMLS CUI [2])
Item
Primary reason medication stopped - Prior RA Medications
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Primary reason medication stopped - Prior RA Medications
Code List
Primary reason medication stopped - Prior RA Medications
CL Item
Lack of efficacy  (11)
CL Item
Non-treatment related Adverse Event  (14)
CL Item
Treatment related toxicity/treatment not tolerated (15)
CL Item
Washout of prohibited medication prior to trial entry  (16)
CL Item
Subject no longer wanted treatment  (17)
CL Item
Unknown (18)
CL Item
Reason medication stopped, other specify (OT)
If other reason for medication stopped, specify - Prior RA Medications
Item
If other reason for medication stopped, specify - Prior RA Medications
text
C0392360 (UMLS CUI [1,1])
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])
Item Group
Screen Failure
C1710476 (UMLS CUI-1)
Was this subject a screen failure?
Item
Was this subject a screen failure?
boolean
C1710476 (UMLS CUI [1])
Screen failure date
Item
Screen failure date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason for screen failure
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason for screen failure
Code List
Reason for screen failure
CL Item
Did not meet inclusion/exclusion criteria (F01)
CL Item
Adverse Event (unspecified) (F02)
CL Item
Protocol deviation (unspecified) (F04)
CL Item
Study closed/terminated (unspecified) (F06)
CL Item
Withdrew consent, specify (F09)
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