ID

23478

Descrição

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

Palavras-chave

Versões (1)
  1. 07/07/2017 07/07/2017 -
Transferido a

7 de julho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Graft versus Host Disease NCT02396628 DRKS00007939

Inglês

Eligibility Graft versus Host Disease NCT02396628 DRKS00007939

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Graft-versus-Host-Disease

Tipo de dados

boolean

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

Histological Confirmation

Tipo de dados

boolean

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

Age

Tipo de dados

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
Descrição

Treatment Failure

Tipo de dados

boolean

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

Informed Consent

Tipo de dados

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
Descrição

Understanding Ability

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0582778
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Descrição

Control Group

Tipo de dados

boolean

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

Comorbidity

Tipo de dados

boolean

2. Active bleeding
Descrição

Bleeding Disorder

Tipo de dados

boolean

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

Asymptomatic

Tipo de dados

boolean

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

Chronic Graft-versus-Host-Disease

Tipo de dados

boolean

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

Infection

Tipo de dados

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
Descrição

JAK2 inhibitor

Tipo de dados

boolean

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

Hypersensitivity to Ruxolitinib

Tipo de dados

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.
Descrição

HIV, HBV, HCV

Tipo de dados

boolean

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

Gynaecological Status

Tipo de dados

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
Descrição

Experimental Drug

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304229
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Similar models

Eligibility Graft versus Host Disease NCT02396628 DRKS00007939

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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