Clinical Trial Results:
Myfortic (enteric-coated mycophenolate sodium) for the treatment of non-infectous intermediate uveitis – a prospective, controlled randomized multicenter trial
|
Summary
|
|
EudraCT number |
2009-009998-10 |
Trial protocol |
DE |
Global end of trial date |
02 Oct 2015
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
02 Dec 2021
|
First version publication date |
02 Dec 2021
|
Other versions |
|
Summary report(s) |
Statistical analysis report Safety report_Adverse events |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
MYCUV-IIT02
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Centre for Ophthalmology, University of Tübingen
|
||
Sponsor organisation address |
Schleichstraße 12, Tübingen, Germany, 72076
|
||
Public contact |
Dr. med. Bodo Wahlländer, Centre for Ophthalmology, University of Tübingen, +49 0911-27312633, christoph.deuter@med.uni-tuebingen.de
|
||
Scientific contact |
Dr. med. Christoph Deuter, Centre for Ophthalmology, University of Tübingen, +49 0911-27312633, christoph.deuter@med.uni-tuebingen.de
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
15 Oct 2015
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
02 Oct 2015
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
02 Oct 2015
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The objective of this clinical trial to evaluate the efficacy, safety and tolerability of enteric-coated mycophenolate sodium in combination with low-dose corticosteroids compared to a monotherapy with low-dose corticosteroids in subjects with non-infectious intermediate uveitis.
|
||
Protection of trial subjects |
This study was reviewed and approved by the ethics committees of the participating study centers as well as by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) in Bonn. The leading ethics committee for this trial was the Clinical Ethics Committee at the University Hospital Tübingen. This study was conducted in accordance with the tenets of the Declaration of Helsinki. All patients received a written patient information. Patients were given sufficient time for consideration and opportunity to ask questions. Finally, written informed consent was obtained at the screening visit, before any studyrelated procedures were performed. Patients received a copy of the signed informed consent form.
|
||
Background therapy |
The following concomitant treatments for uveitis were allowed during the study: • Oral acetazolamide (e.g. Diamox®) in a dose up to 250 mg BID. Dose had to be stable for at least 2 weeks prior to screening. Tapering should be started at visit 4 (month 3) at the discretion of the investigator. • Topical prednisolone, topical non-steroidal anti-inflammatory drugs. Dose had to be stable for at least 2 weeks prior to screening. Tapering should be started at visit 4 (month 3) at the discretion of the investigator. • Mydriatics | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Apr 2010
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Germany: 47
|
||
Worldwide total number of subjects |
47
|
||
EEA total number of subjects |
47
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
47
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
Centre for Ophthalmology, University Hospital Tübingen, Germany (PD Dr. Christoph Deuter) • Eye Clinic, Klinikum Chemnitz gGmbH, Chemnitz, Germany (Prof. Dr. Katrin Engelmann) • Department of Ophthalmology, St. Franziskus Hospital, Münster, Germany (Prof. Dr. Arnd Heiligenhaus) • Department of Ophthalmology, Technical University of Munich, | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
Unfortunately, the projected number of 144 patients could not be reached and the recruitment had to be stopped prematurely after screening of 47 patients and randomisation of 44 patients at eight sites. | |||||||||
|
Period 1
|
||||||||||
Period 1 title |
Baseline period (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
Blinding implementation details |
It was an open-label study. Patients who were allocated to the control group and who developed the first relapse within 6 months after randomisation changed to the ‘crossover group’.
|
|||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
Prednisolone + Myfortic | |||||||||
Arm description |
Treatment group: Tapering of oral prednisolone continued over approximately 3 months to a maintenance dose of 5 mg/day plus EC-MPS (Myfortic; Novartis, Basel, Switzerland) at a dose of 720 mg/day during the first week and 1440 mg/day from week 2 onwards. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Prednisolone
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
Decortin H®
|
|||||||||
Pharmaceutical forms |
Capsule, hard
|
|||||||||
Routes of administration |
Oral use
|
|||||||||
Dosage and administration details |
Tapering of oral prednisolone continued over approximately 3 months to a maintenance dose of 5 mg/day
|
|||||||||
Investigational medicinal product name |
Myfortic
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Capsule
|
|||||||||
Routes of administration |
Oral use
|
|||||||||
Dosage and administration details |
Tapering of oral prednisolone continued over approximately 3 months to a maintenance dose of 5 mg/day plus EC-MPS (Myfortic; Novartis, Basel, Switzerland) at
a dose of 720 mg/day during the first week and 1440 mg/day from week 2 onwards.
|
|||||||||
|
Arm title
|
Control arm | |||||||||
Arm description |
Control group: Tapering of oral prednisolone continued over approximately 3 months to a maintenance dose of 5 mg/day. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Prednisolone
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
Decortin H
|
|||||||||
Pharmaceutical forms |
Capsule, hard
|
|||||||||
Routes of administration |
Oral use
|
|||||||||
Dosage and administration details |
Tapering of oral prednisolone continued over approximately 3 months to a maintenance dose of
5 mg/day.
|
|||||||||
|
||||||||||
| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 47 patients were enrolled and 41 were evaluable (22 in the treatment group and 19 in the control group) |
||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Baseline period
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Subject analysis sets
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Final analysis
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Intent-to-treat population and safety population were defined as all subjects who received at least one dose of prednisolone or
EC-MPS and did have at least one post-baseline assessment or at least one post-therapy safety assessment, respectively.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Prednisolone + Myfortic
|
||
Reporting group description |
Treatment group: Tapering of oral prednisolone continued over approximately 3 months to a maintenance dose of 5 mg/day plus EC-MPS (Myfortic; Novartis, Basel, Switzerland) at a dose of 720 mg/day during the first week and 1440 mg/day from week 2 onwards. | ||
Reporting group title |
Control arm
|
||
Reporting group description |
Control group: Tapering of oral prednisolone continued over approximately 3 months to a maintenance dose of 5 mg/day. | ||
Subject analysis set title |
Final analysis
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Intent-to-treat population and safety population were defined as all subjects who received at least one dose of prednisolone or
EC-MPS and did have at least one post-baseline assessment or at least one post-therapy safety assessment, respectively.
|
||
|
|||||||||||||
End point title |
time from study entry to the first relapse [1] | ||||||||||||
End point description |
To evaluate whether a EC-MPS based regimen will be able to reduce the probability of a relapse compared to steroid therapy alone. The primary endpoint of the study is defined as the time from study entry to the first relapse.
Definition of relapse:
• Deterioration of best corrected visual acuity (BCVA) ≥ 3 lines
compared to best BCVA from baseline.
At least 2-step increase of vitreous haze compared to lowest
grade of vitreous haze from baseline or increase from 3+ to 4+.
• At least 2-step increase of anterior chamber cells compared to
lowest grade of anterior chamber cells from baseline or increase
from 3+ to 4+.
• New onset or worsening of preexisting cystoid macular edema,
proven by Optical Coherence Tomography (OCT)
• New onset or worsening of retinal vasculitis (sheating and/or
leakage of retinal vessels), proven by fluorescein angiography
(FA).
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Until first relapse
|
||||||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis can be found in the attached documents |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||
|
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
The whole duration of the trial
|
||
Assessment type |
Systematic | ||
|
Dictionary used for adverse event reporting
|
|||
Dictionary name |
MedDRA | ||
Dictionary version |
1
|
||
| Frequency threshold for reporting non-serious adverse events: 1% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Safety Report can be found in the attached documents |
|||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
|||
| http://www.ncbi.nlm.nih.gov/pubmed/28903965 |
|||
