Clinical Trial Results:
Crise Rénale sclérodermique : amélioration du pronostic par adjonction de Bosentan au traitement de référence de la maladie.
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Summary
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EudraCT number |
2010-021452-26 |
Trial protocol |
FR |
Global end of trial date |
20 Apr 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jun 2022
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First version publication date |
29 Jun 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
P081217
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01241383 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
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Sponsor organisation address |
4 Avenue Victoria, PARIS, France, 75004
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Public contact |
Investigateur Coordonnateur, Dr Alice BEREZNE, aberezne@ch-annecygenevois.fr
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Scientific contact |
Investigateur Coordonnateur, Dr Alice BEREZNE
, aberezne@ch-annecygenevois.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
18 Oct 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Apr 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Apr 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
L'objectif principal est de déterminer l'efficacité à un an du bosentan, prescrit durant 6 mois, chez des patients présentant une crise rénale sclérodermique venant d'être diagnostiquée. En l'absence de toute étude et de possibilité de réaliser à ce stade de nos connaissances une étude randomisée contre placebo, nous nous donnons l'objectif d'obtenir au cours de cette étude, au moins la même efficacité en terme de survie et de taux d'insuffisance rénale que ce qui est observé dans les études les plus récentes de la littérature.
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Protection of trial subjects |
Présence d'un DSMB
Remise au patient d'un carnet de suivi de l’observance (recueil des doses de Tracleer®, d’IEC, de notifier les éventuels EI).
Questionnaires SF36 et HAQ pour le patient.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
09 Mar 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 16
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Worldwide total number of subjects |
16
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EEA total number of subjects |
16
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
8
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||
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Pre-assignment
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Screening details |
number of patients screened=44 28 patients not included: - 20 with non inclusion criteria (other disease or delay for inclusion) - 7 not included because of organisation problems (non declared centers) - 1 no reason known | ||||||||
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Period 1
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Period 1 title |
Etude "SCS REINBO" overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||
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Arms
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Arm title
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one arm | ||||||||
Arm description |
Bosentan en association du traitement conventionnel incluant un IEC | ||||||||
Arm type |
one arm | ||||||||
Investigational medicinal product name |
Tracleer
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Investigational medicinal product code |
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Other name |
Bosentan
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Pharmaceutical forms |
Buccal tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Les médicaments utilisés dans le cadre de cette étude seront le Tracleer® 62,5 et 125 mg.
Le traitement sera débuté à 62,5 mg deux fois par jour pendant 28 jours et en l’absence d’intolérance, augmenté à 125 mg deux fois par jours pendant 5 mois (5 fois 28 jours de traitement).
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Baseline characteristics reporting groups
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Reporting group title |
Etude "SCS REINBO" overall trial
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Reporting group description |
Bras unique_ Bosentan en association avec le traitement conventionnel incluant un IEC | ||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
one arm
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Reporting group description |
Bosentan en association du traitement conventionnel incluant un IEC | ||
Subject analysis set title |
workaround needs
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
We reported the same number of subjects declared in the single arm for the workaround to work (note that no subjects were included in this subgroup).
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End point title |
Renal survival at one year defined as increase of two-fold of creatine level | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Le critère de jugement principal sera l’évolution de la fonction rénale à 6 mois et 1 an du début de la crise rénale
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| Notes [1] - One arm [2] - workaround needs |
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Statistical analysis title |
Analyse descriptive | |||||||||
Statistical analysis description |
Single-arm descriptive analysis of 16 subjects only.
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Comparison groups |
one arm v workaround needs
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Number of subjects included in analysis |
32
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Analysis specification |
Pre-specified
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Analysis type |
other [3] | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Analyse descriptive | |||||||||
Parameter type |
renal survival at M6 and M12 | |||||||||
Confidence interval |
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Variability estimate |
Standard deviation
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| Notes [3] - We reported the same number of subjects declared in the single arm for the workaround to work (note that no subjects were included in the subgroup workarounds needs). |
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Adverse events information
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Timeframe for reporting adverse events |
12 months
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19
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Reporting groups
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Reporting group title |
Etude ScS REINBO
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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11 Jan 2011 |
MS1
- ajout de prélèvements aux visites M6 et M12 ;
- ajout de la liste investigateur (inchangée) au niveau du protocole
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16 Dec 2011 |
MS2 : ajout de nouveaux centres |
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10 Jan 2012 |
MS3 : interruption des inclusions |
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06 Apr 2012 |
MS4 : Description du renforcement des mesures de surveillances des patients traités par le Bosentan suite à la demande de l’afssaps. |
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05 Jun 2012 |
MS5:
- demande d'autorisation pour la reprise des inclusions dans l’étude SCS-Reinbo suite aux conclusions du rapport des membres du Comité de surveillance indépendant
- pour pallier à l'absence des inclusions depuis la première réunion du CSI en date du 05/01/2012, nous souhaitons prolonger la période des inclusions de 6 mois, soit fin de la recherche au 02/05/2014.
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23 Feb 2013 |
MS6 :
- Allongement du délai autorisé entre le diagnostic de la crise rénale sclérodermique et l’inclusion dans le protocole.
- Suppression du test grossesse Béta HCG sanguin à la visite M6.
- Ajout de l’interdiction de prescrire du Tacleer pendant les 6 mois de suivi des patients.
- Ajout de 3 nouveaux centres investigateurs
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11 Oct 2013 |
MS7 : Prolongation de la durée des inclusions de 1 an avec une fin d’étude au 09/09/2015 afin d’atteindre les objectifs en termes d’inclusions |
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07 Mar 2014 |
MS8 : Mise à jour de la liste des centres investigateurs. |
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20 Apr 2015 |
MS9 :
- Mise à jour des coordonnées des personnes en charge de l’étude chez le promoteur et de l’investigatrice coordinatrice qui exerce maintenant à Pringy.
- Ajout d’une précision dans le protocole sur le nombre de patients à inclure.
- Mise à jour de la liste des investigateurs.
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Interruptions (globally) |
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| Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
| None reported | |||||||
