ID

23478

Beschreibung

Responsible Party: Prof. Dr. Nikolas von Bubnoff, Coordinating Investigator, University Hospital Freiburg ClinicalTrials.gov Identifier: NCT02396628 History of Changes Other Study ID Numbers: RIG-P000814 2014-004267-20 ( EudraCT Number ) DRKS00007939 ( Registry Identifier: DRKS ) Study First Received: March 10, 2015 Last Updated: May 3, 2017 Ruxolitinib In GvHD (RIG) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02396628

Link

https://clinicaltrials.gov/ct2/show/NCT02396628

Stichworte

Versionen (1)
  1. 07.07.17 07.07.17 -
Hochgeladen am

7. Juli 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Graft versus Host Disease NCT02396628 DRKS00007939

Englisch

Eligibility Graft versus Host Disease NCT02396628 DRKS00007939

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Acute skin, intestinal or liver GvHD > grade 1 according to standard criteria
Beschreibung

Graft-versus-Host-Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018133
2. Histological confirmation in case of acute intestinal GvHD
Beschreibung

Histological Confirmation

Datentyp

boolean

Alias
UMLS CUI [1]
C0449575
3. Age ≥18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. Failure of previous treatment, defined as presence of at least one of the following criteria: 1. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and lack of response after at least 7 days treatment 2. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and progression after at least 3 days of treatment 3. Failure to taper the prednisone/prednisolone dose to 0.6 mg/kg/day or methylpredniso-lone dose to <0.5 mg/kg/day
Beschreibung

Treatment Failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0162643
5. Written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
6. Ability to understand the nature of the study and the study related procedures and to comply with them
Beschreibung

Understanding Ability

Datentyp

boolean

Alias
UMLS CUI [1]
C0582778
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Beschreibung

Control Group

Datentyp

boolean

Alias
UMLS CUI [1]
C0009932
1. Uncontrolled underlying disease
Beschreibung

Comorbidity

Datentyp

boolean

2. Active bleeding
Beschreibung

Bleeding Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
3. Absence of clinical signs of acute GvHD
Beschreibung

Asymptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0231221
4. Diagnostic or distinctive clinical signs of chronic GvHD
Beschreibung

Chronic Graft-versus-Host-Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0867389
5. Uncontrolled bacterial, viral or fungal infection
Beschreibung

Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
6. Any previous JAK2 inhibitor treatment prior to study enrolment, except Ruxolitinib given prior to the allogeneic stem cell transplantati
Beschreibung

JAK2 inhibitor

Datentyp

boolean

Alias
UMLS CUI [1]
C4086530
7. Known Hypersensitivity to Ruxolitinib or any of the excipients
Beschreibung

Hypersensitivity to Ruxolitinib

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2931926
8. Known positivity for HIV, Hepatitis B or Hepatitis C at the time of screening.
Beschreibung

HIV, HBV, HCV

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1112419
9. Female patients who are pregnant or breast feeding
Beschreibung

Gynaecological Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
10. Concomitant use of any other investigational drug within the last thirty days before the start of this study
Beschreibung

Experimental Drug

Datentyp

boolean

Alias
UMLS CUI [1]
C0304229
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Ähnliche Modelle

Eligibility Graft versus Host Disease NCT02396628 DRKS00007939

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Graft-versus-Host-Disease
Item
1. Acute skin, intestinal or liver GvHD > grade 1 according to standard criteria
boolean
C0018133 (UMLS CUI [1])
Histological Confirmation
Item
2. Histological confirmation in case of acute intestinal GvHD
boolean
C0449575 (UMLS CUI [1])
Age
Item
3. Age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Treatment Failure
Item
4. Failure of previous treatment, defined as presence of at least one of the following criteria: 1. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and lack of response after at least 7 days treatment 2. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and progression after at least 3 days of treatment 3. Failure to taper the prednisone/prednisolone dose to 0.6 mg/kg/day or methylpredniso-lone dose to <0.5 mg/kg/day
boolean
C0162643 (UMLS CUI [1])
Informed Consent
Item
5. Written informed consent
boolean
C0021430 (UMLS CUI [1])
Understanding Ability
Item
6. Ability to understand the nature of the study and the study related procedures and to comply with them
boolean
C0582778 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
0. Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Comorbidity
Item
1. Uncontrolled underlying disease
boolean
Bleeding Disorder
Item
2. Active bleeding
boolean
C0005779 (UMLS CUI [1])
Asymptomatic
Item
3. Absence of clinical signs of acute GvHD
boolean
C0231221 (UMLS CUI [1])
Chronic Graft-versus-Host-Disease
Item
4. Diagnostic or distinctive clinical signs of chronic GvHD
boolean
C0867389 (UMLS CUI [1])
Infection
Item
5. Uncontrolled bacterial, viral or fungal infection
boolean
C0009450 (UMLS CUI [1])
JAK2 inhibitor
Item
6. Any previous JAK2 inhibitor treatment prior to study enrolment, except Ruxolitinib given prior to the allogeneic stem cell transplantati
boolean
C4086530 (UMLS CUI [1])
Hypersensitivity to Ruxolitinib
Item
7. Known Hypersensitivity to Ruxolitinib or any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C2931926 (UMLS CUI [1,2])
HIV, HBV, HCV
Item
8. Known positivity for HIV, Hepatitis B or Hepatitis C at the time of screening.
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Gynaecological Status
Item
9. Female patients who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Experimental Drug
Item
10. Concomitant use of any other investigational drug within the last thirty days before the start of this study
boolean
C0304229 (UMLS CUI [1])
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