STRIVE is a multicentre randomiSed controlled TRial of IntraVEnous Immunoglobulin (IVlg) versus standard therapy for the treatment of transverse myelitis in adults and children.

Trial Overview

STRIVE is a multi-centred trial taking place in the United Kingdom. Its primary objective is to evaluate if early treatment with intravenous immunoglobulin (IVIg) added to standard therapy (steroids) is of extra benefit in patients who present with symptoms of TM for the first time.

It will take about three years to complete and publication of outcomes is expected in summer 2018. The trial is being funded by the National Institute for Health Research.

Why is this important for the TM Society?

There are a number of reasons why this trial is welcome news for us.
  • In addition to establishing whether the IVig  treatment produces better outcomes, the trial itself will raise awareness of TM amongst the medical profession. 
  • It will effectively establish 'centres of excellence' in the treatment of TM and NMO, because all the participants will be channeled through the participating sites. That means that now and in the future, when someone gets TM, there will be a number of hospitals with good experience of the condition. 
  • Patients will be measured for functionality and pain, at 3, 6 and 12 months post onset. This is a longer period of interest in how a TM patient is recovering than is normal for most hospitals at the moment. 

What can the TM Society do to help?

For the trial to be valid, we need to get around 170 patients to these hospitals by 2017. Participants can be:
  • children or adults
  • with a diagnosis of TM or NMO
  • and they must be within 21 days of their first onset.

The TM Society is working to publicise the STRIVE trial to ensure that we get an adequate number of patients participating.

Why is a trial necessary?

TM causes weakness or complete paralysis of the legs and sometimes the arms with loss of bladder and bowel control and loss of feeling in the skin. It usually develops over several hours, and can become severely and permanently disabling. It occurs when the immune system targets the spinal cord. TM affects adults and children with equal frequency and severity causing significant lifelong disability, often despite undergoing a protracted and intensive rehabilitative regime. As people can be affected in their prime working life, the condition poses a significant demand on the health resources in the UK and also results in loss of productivity. Early recognition, diagnosis and treatment are considered integral to the management of this condition. The diagnostic criteria of an international TM Consortium Working Group, in operation for about 10 years, have helped clinicians and scientists improve the diagnosis of TM and accurately select patients to evaluate treatments. However, despite this, there are no good studies to determine the best treatment. 

What is being trialled?

As in most immune disorders, treatment involves strategies to suppress the immune response to reduce irreversible spinal cord damage. Typically, this includes steroids, intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) – but the treatment that is given is based on expert panel recommendations rather than the results of well controlled trials. IVIg is used increasingly in the management of a range of neurological conditions and is easy to administer. This multi-centre randomised trial will evaluate if additional treatment with intravenous immunoglobulin (IVIg) is of added benefit in TM when compared to standard therapy.

What will the trial entail?

The trial requires a planned sample size of 170 patients. This constitutes two groups: 85 in the control arm and 85 in the treatment arm. These numbers assume that 10% of participants will leave the trial early. Participants randomised to the control group of this study will be prescribed intravenous steroids in line with the local clinical practice. Those randomised to the intervention group will additionally receive IVIg for up to five days. 

Participating Study Sites

There are a number of hospitals participating in this study throughout the UK. The hospitals involved are listed below together with the service offered - either Paediatric or Adult.
Patients must be recruited from within the hospitals where the trial is being conducted. 

Who can participate?

If you are newly diagnosed with TM or NMO and are within 21 days of experiencing the first symptoms, you can have your GP or consultant refer you to one of the hospitals below that is nearest to you. 

To measure the effectiveness of treatment, standardized disease specific and generic  tools that evaluate disability will be used. They will be easy to administer within the NHS service structure during routine follow-up appointments. Importantly, the effect of this treatment on the quality of life in patients will be measured as well as the economic impact on the NHS. The trial will be conducted to a high standard in order to generate evidence to inform clinical decision making in the NHS.

What groups are behind this trial?

To perform this trial, a group of clinicians, clinician-scientists and social scientists specialising in looking after adults and children with immune mediated disorders and with a proven track record in leading and/or participating in large multi-centre trials, have teamed up with a successful and nationally renowned clinical trials unit based at Kings College Hospital. By way of public involvement, the Transverse Myelitis Society (UK), MS Society (UK), and the Guthy-Jackson Charitable Foundation, which supports multinational Neuromyelitis Optica research, have supported the research design, and their involvement will continue. 

Further Information

Further information about the STRIVE clinical trial can be found at the STRIVE page of the National Institute for Health Research website and on the ISRCTN clinical trials register.
The Clinical Trial Manager is  Onyi Diribe at King's Clinical Trials Unit at KHP, King's College London. 

Participating Study Sites 

The sites that are participating in the STRIVE trial are listed below. If the site is OPEN for recruitment, the city designation is in BOLD. The sites not listed in bold are due to begin recruitment over the next few months.

The information that follows is: 
  • the hospital name (in italics), 
  • the name of the NHS Trust, 
  • the service offered designated as Adults or Paeds (for Paediatric) 
  • and the name of the Principal Investigator (PI). 
LONDON  Evelina Children's Hospital, Guy’s & St Thomas’ NHS Foundation Trust (Paeds)  -  PI Dr Ming Lim & Dr Michael Absoud
LONDON  St Thomas's Hospital, Guy's and St Thomas' NHS Foundation Trust (Adults) - PI Dr Victoria Williams
LONDON Great Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust (Paeds) - PI Dr Cheryl Hemingway
LONDON  Royal London Hospital, Barts Health NHS Trust (Adults) - PI Prof Gavin Giovannoni
LONDON  King’s College Hospital, King’s College Hospital NHS Foundation Trust (Adults) - PI Dr Peter Brex
LIVERPOOL Alder Hey Children’s Hospital, Alder Hey Children’s NHS   Foundation Trust (Paeds) - PI Dr Rachel Kneen
LIVERPOOL The Walton Centre,  The Walton Centre NHS Foundation Trust (Adults) - PI Dr Anu Jacob
OXFORD Children's Hospital, John Radcliffe Hospital, Oxford University Hospitals NHS Trust (Paeds) - PI Dr Kate Lamb
OXFORD John Radcliffe Hospital, Oxford University Hospitals NHS Trust (Adults) - PI Dr Jacqueline Palace
BIRMINGHAM Birmingham Children’s Hospital, Birmingham Children’s Hospital NHS Foundation Trust (Paeds) - PI Dr Evangeline Wassmer
BIRMINGHAM Queen Elizabeth Hospital, University Hospitals Birmingham NHS Trust (Adults) - PI Dr Saiju Jacob
CARDIFF The Noah's Ark Children's Hospital for Wales, Cardiff & Vale University Health Board, NHS Wales (Paeds - PI Dr Johann te Water Naude
CARDIFF University Hospital of Wales, Cardiff & Vale University Health Board, NHS Wales (Adult) - PI Prof Neil Robertson
BRISTOL Bristol Royal Hospital for Children, University Hospital Bristol NHS Trust (Paeds) - PI Dr Kayal Vijayakumar
BRISTOL North Bristol NHS Trust (Adults) - PI tba
MANCHESTER Royal Manchester Children's Hospital, Central Manchester University Hospitals NHS Foundation Trust (Paeds) -
PI Dr Siobhan West
SOUTHAMPTON  Southampton General Hospital, University Southampton NHS Foundation Trust (Paeds) - PI Dr Katherine Forrest 
SOUTHAMPTON  Southampton General Hospital, University Southampton NHS Foundation Trust (Adults) - PI Dr Ian Galea
NEWCASTLE  Great Northern Children's Hospital, Newcastle Hospitals NHS Foundation Trust (Paeds) - PI Dr Venkateswaran Ramesh
NEWCASTLE  Royal Victoria Infirmary, Newcastle Hospitals NHS Foundation Trust (Adults) - PI Dr Martin Duddy 
NOTTINGHAM  Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust (Paeds) - PI Dr William Whitehouse
EDINBURGH Western General Hospital, NHS Lothian (Adults) - PI Dr Katy Murray
Transverse Myelitis Society