ID

23478

Description

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

Lien

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

Mots-clés

Versions (1)
  1. 07/07/2017 07/07/2017 -
Téléchargé le

7 juillet 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Graft versus Host Disease NCT02396628 DRKS00007939

Anglais

Eligibility Graft versus Host Disease NCT02396628 DRKS00007939

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Graft-versus-Host-Disease

Type de données

boolean

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

Histological Confirmation

Type de données

boolean

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

Age

Type de données

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
Description

Treatment Failure

Type de données

boolean

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

Informed Consent

Type de données

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
Description

Understanding Ability

Type de données

boolean

Alias
UMLS CUI [1]
C0582778
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Description

Control Group

Type de données

boolean

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

Comorbidity

Type de données

boolean

2. Active bleeding
Description

Bleeding Disorder

Type de données

boolean

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

Asymptomatic

Type de données

boolean

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

Chronic Graft-versus-Host-Disease

Type de données

boolean

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

Infection

Type de données

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
Description

JAK2 inhibitor

Type de données

boolean

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

Hypersensitivity to Ruxolitinib

Type de données

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.
Description

HIV, HBV, HCV

Type de données

boolean

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

Gynaecological Status

Type de données

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
Description

Experimental Drug

Type de données

boolean

Alias
UMLS CUI [1]
C0304229
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Similar models

Eligibility Graft versus Host Disease NCT02396628 DRKS00007939

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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