ID

40301

Beschreibung

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

Stichworte

Versionen (1)
  1. 31.03.20 31.03.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

31. März 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

Englisch

Status of Treatment Blind; Pregnancy Information; Pharmacogenetic Research Withdrawal of Consent; Study Conclusion; Infusion

1 Formulare  
Status of Treatment Blind
Beschreibung

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Beschreibung

If yes, complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product forms as appropriate

Datentyp

boolean

Alias
UMLS CUI [1]
C3897431
Date/time blind broken
Beschreibung

Date/time blind broken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C1264639
Reason blind broken
Beschreibung

Reason blind broken

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Pregnancy Information
Beschreibung

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschreibung

If Yes, complete the paper Pregnancy Notification form

Datentyp

boolean

Alias
UMLS CUI [1]
C3828490
Did a female partner of the male subject become pregnant during the study?
Beschreibung

If Yes, complete the paper Pregnancy Notification form Check Not Applicable if female partner not of childbearing potential or no female partner

Datentyp

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008972
Pharmacogenetic Research Withdrawal of Consent
Beschreibung

Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C0031325
Has subject withdrawn consent for PGx research?
Beschreibung

If yes, date informed consent withdrawn

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
Date informed consent withdrawn
Beschreibung

Date informed consent withdrawn

Datentyp

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0011008
Has a request been made for PGx sample destruction?
Beschreibung

Has a request been made for PGx sample destruction?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
If a request has been made for PGx sample destruction, check reason
Beschreibung

If a request has been made for PGx sample destruction, check reason

Datentyp

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
UMLS CUI [1,5]
C0392360
Sample type
Beschreibung

Sample type

Datentyp

text

Alias
UMLS CUI [1]
C2347029
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Beschreibung

Date of subject completion or withdrawal

Datentyp

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Beschreibung

If yes, complete primary reason for withdrawal

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Beschreibung

Primary reason for withdrawal

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Infusion
Beschreibung

Infusion

Alias
UMLS CUI-1
C0574032
Was an infusion administered at this visit?
Beschreibung

If yes was Infusion A or B administered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0545082
Was Infusion A or B administered
Beschreibung

Was Infusion A or B administered

Datentyp

text

Alias
UMLS CUI [1]
C0574032
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Ähnliche Modelle

Status of Treatment Blind; Pregnancy Information; Pharmacogenetic Research Withdrawal of Consent; Study Conclusion; Infusion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date/time blind broken
Item
Date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (Z)
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Did a female partner of the male subject become pregnant during the study?
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (X)
Item Group
Pharmacogenetic Research Withdrawal of Consent
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Has subject withdrawn consent for PGx research?
Item
Has subject withdrawn consent for PGx research?
boolean
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Date informed consent withdrawn
Item
Date informed consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Has a request been made for PGx sample destruction?
Item
Has a request been made for PGx sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
If a request has been made for PGx sample destruction, check reason
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0392360 (UMLS CUI [1,5])
If a request has been made for PGx sample destruction, check reason
Code List
If a request has been made for PGx sample destruction, check reason
CL Item
Subject withdrew consent for PGx (3)
CL Item
Screen failure (2)
CL Item
Other, specify (Z)
Sample type
Item
Sample type
text
C2347029 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse event  (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation  (3)
CL Item
Subject reached protocol-defined stopping criteria (4)
CL Item
Study closed/terminated  (5)
CL Item
Lost to follow-up  (6)
CL Item
Withdrew consent, specify (8)
Item Group
Infusion
C0574032 (UMLS CUI-1)
Was an infusion administered at this visit?
Item
Was an infusion administered at this visit?
boolean
C0574032 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Item
Was Infusion A or B administered
text
C0574032 (UMLS CUI [1])
Was Infusion A or B administered
Code List
Was Infusion A or B administered
CL Item
Infusion A (A)
CL Item
Infusion B (B)
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