Clinical Trial Results:
A multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin (IVIg) versus standard therapy for the treatment of transverse myelitis in adults and children
Summary
|
|
EudraCT number |
2014-002335-34 |
Trial protocol |
GB |
Global end of trial date |
11 May 2016
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
06 Oct 2018
|
First version publication date |
06 Oct 2018
|
Other versions |
|
Summary report(s) |
FINAL STUDY REPORT |
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 |
STRiVE
|
||
Additional study identifiers
|
|||
ISRCTN number |
ISRCTN12127581 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Guy's and St Thomas' NHS Foundation Trust
|
||
Sponsor organisation address |
Great Maze Pond, London, United Kingdom, SE19RT
|
||
Public contact |
Dr Ming Lim, Guy's and St Thomas NHS Foundation Trust, 0044 0207188 4002, Ming.Lim@gstt.nhs.uk
|
||
Scientific contact |
Dr Ming Lim, Guy's and St Thomas NHS Foundation Trust, 0044 0207188 4002, Ming.Lim@gstt.nhs.uk
|
||
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 |
11 May 2016
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
11 May 2016
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
11 May 2016
|
||
Was the trial ended prematurely? |
Yes
|
||
General information about the trial
|
|||
Main objective of the trial |
The primary objective of this randomized controlled trial is to evaluate if additional, and early, treatment with IVIg is of extra benefit in TM when compared to the current standard therapy of intravenous steroids.
|
||
Protection of trial subjects |
Patients will be eligible for inclusion in the trial if on presentation they:
Are aged 1 year or over
Have been diagnosed with: EITHER acute first onset transverse myelitis
(The TM CONSORTIUM WORKING GROUP 2002 criteria for probable TM will be used. Hence, following clinical and radiological exclusion of a compressive myelopathy
|
||
Background therapy |
none | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Jul 2015
|
||
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 |
United Kingdom: 2
|
||
Worldwide total number of subjects |
2
|
||
EEA total number of subjects |
2
|
||
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) |
1
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
1
|
||
85 years and over |
0
|
|
||||||||||||||||
Recruitment
|
||||||||||||||||
Recruitment details |
Only 2 participants were recruited into this multi center trial located within the UK | |||||||||||||||
Pre-assignment
|
||||||||||||||||
Screening details |
Patients will be eligible for inclusion in the trial if on presentation they: Are aged 1 year or over Have been diagnosed with: EITHER acute first onset transverse myelitis (The TM CONSORTIUM WORKING GROUP 2002 criteria for probable TM will be used. Hence, following clinical and radiological exclusion of a compressive myelopathy | |||||||||||||||
Period 1
|
||||||||||||||||
Period 1 title |
Overall Trial (overall period)
|
|||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
|
|||||||||||||||
Blinding used |
Single blind | |||||||||||||||
Roles blinded |
Assessor [1] | |||||||||||||||
Blinding implementation details |
Due to the technical challenges of masking IVIg from saline, the need for rapid recruitment and the fact that follow-up will be many months after the event using objective well-defined clinical endpoints; treatment will not be blinded (no placebo). The trial manager, pharmacy, and those administering treatment are not blinded; whilst staff carrying out primary outcome assessments at follow-up and statistical analyses will be blinded to intervention.
|
|||||||||||||||
Arms
|
||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||
Arm title
|
Intervention | |||||||||||||||
Arm description |
Only1 participants were recruited into this arm before early termination. Therefore no statistical analysis has been performed. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
IViG
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
Intratect
|
|||||||||||||||
Pharmaceutical forms |
Solution for injection/infusion
|
|||||||||||||||
Routes of administration |
Intravenous drip use
|
|||||||||||||||
Dosage and administration details |
Participants were randomised 1:1 to treatme.nt with IV methylprednisolone alone (control arm) or IV methylprednisolone plus 2kg/kg IVIG in divided doses (treatment arm).
|
|||||||||||||||
Arm title
|
No intervention | |||||||||||||||
Arm description |
Participants were randomised 1:1 to treatment with IV methylprednisolone alone (control arm) as standard of care. | |||||||||||||||
Arm type |
No intervention | |||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
|||||||||||||||
Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: Due to the technical challenges of masking IVIg from saline, the need for rapid recruitment and the fact that follow-up will be many months after the event using objective well-defined clinical endpoints; treatment will not be blinded (no placebo). The trial manager, pharmacy, and those administering treatment are not blinded; whilst staff carrying out primary outcome assessments at follow-up and statistical analyses will be blinded to intervention. |
||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Intervention
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Only1 participants were recruited into this arm before early termination. Therefore no statistical analysis has been performed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
No intervention
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants were randomised 1:1 to treatment with IV methylprednisolone alone (control arm) as standard of care. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Intervention
|
||
Reporting group description |
Only1 participants were recruited into this arm before early termination. Therefore no statistical analysis has been performed. | ||
Reporting group title |
No intervention
|
||
Reporting group description |
Participants were randomised 1:1 to treatment with IV methylprednisolone alone (control arm) as standard of care. |
|
|||||||||||||
End point title |
Clinical Endpoint [1] | ||||||||||||
End point description |
The primary objective of the study was to evaluate if additional and early treatment with IVIG
is of extra benefit in transverse myelitis compared to standard therapy of intravenous
steroids. An improvement of 2 points or greater on the ASIA Impairment scale (classified A-E) at 6 months after randomisation, compared to the value measured at baseline just prior to randomisation.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
baseline to 6 months post randomisation
|
||||||||||||
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: Trial was terminated early, with only 1 participant randomised to intervional arm and 1 participant to non interventional arm. No analysis performed. |
|||||||||||||
|
|||||||||||||
Notes [2] - Trial was discontinued due to inability to recruit. Only 2 participants randomised and 0 completed. [3] - Trial was discontinued due to inability to recruit. Only 2 participants randomised and 0 completed. |
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
randomisation to 6 months
|
|||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||
Dictionary version |
17.1
|
|||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||
Reporting group title |
Group 1 - Intervention
|
|||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||
Reporting group title |
Group 2 - No Intervention
|
|||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||
|
|
|||
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. | |||
Study was ended prematurely, after12months of recruitment. 2 Participants randomised into the study were withdrawn from the study following their 6-month visit post randomisation visit. As n=2 no statistical analysis will be carried out on the data | |||
Online references |
|||
http://www.ncbi.nlm.nih.gov/pubmed/28639937 |