Take Part in Clinical Trials

Open Clinical Trials

PREDSS – PRednisolone in Early Diffuse Systemic Sclerosis

What is the study and why is it important?

The PRedSS (PRednisolone in Early Diffuse Systemic Sclerosis) study is a research investigation with the aim of testing whether or not prednisolone can help people living with early diffuse scleroderma. Prednisolone is a widely used corticosteroid, that is prescribed to treat a number of inflammatory and autoimmune conditions.

Drugs which have an effect on the immune system, referred to as immunosuppressants, are generally prescribed by clinicians to those with early diffuse systemic sclerosis (dcSSc), however many of the debilitating symptoms experienced by patients have an inflammatory component. These symptoms can have a profound impact on an individual's quality of life, however patients tend not to be given corticosteroids to reduce these because of the potentially harmful side-effects. Several clinicians are often unsure about whether or not prescribe prednisolone to those living with early dcSSc, as corticosteroids such as these may lead to increased risk of kidney failure. There is a lack of evidence within this area and so there is a major need for a study such as PRedSS.

What is the study process?

Participants of the study are randomly placed into one of two groups. One group will receive the prednisolone in the form of an oral capsule, whereas the other group will receive a placebo ('dummy' treatment). This will be for 6 months, and the overall results will be compared to see if one treatment is better than the other. The study is double-blind, meaning that neither the individual nor their doctor will know which treatment group each patient is in. Manchester Clinical Trials Unit (MCTU) will process the data and a team of researchers at the University of Manchester, led by Professor Ariane Herrick, will analyse the results. For more information on what the study involves, please head to: http://www.predss.org/index.php/the-study/what-does-the-study-involve/.

Who is eligible?

Identifying patients from this rare disease patient is critical for the success of this investigation, so if you are aged over 18 and are presenting with dcSSc with skin involvement of less than three years, extending to proximal limb and/or trunk, then please do get in touch with the team here: http://www.predss.org/index.php/contact/.


RECITAL – Rituximab versus cyclophosphamide for the treatment of connective tissue disease-associated interstitial lung disease (RECITAL)

What is the study and why is it important?

RECITAL is a clinical trial comparing two existing treatments, cyclophosphamide and rituximab, for the treatment of moderate to severe scleroderma-associate lung fibrosis. Intravenous cyclophosphamide is the current usual treatment for this. The aim of the study is to show the tolerability and efficacy of intravenous rituximab, with the hope of improving NHS access to the drug in the future (if successful).

Lung fibrosis is also referred to as interstitial lung disease (ILD) and is characterised by inflammation and scarring of the lung. It is currently treated by intravenous cyclophosphamide (alongside oral azathioprine), but in some cases this form of immunosuppression is not effective in preventing deterioration. Recent reports have indicated that rituximab is a potential route to stabilising or improving ILD, and so this study has been launched to compare the two therapeutic methods.

What is the study process?

The study, led by Professor Toby Maher, is based at the Royal Brompton Hospital and is recruiting participants from eight to twelve UK centres. A total of 116 patients will be enrolled. Patients who wish to take part will be asked to attend a screening appointment in which various tests, including lung function, are performed. If suitable, an individual will be randomised to either form of treatment and can expect to start this treatment within one month of screening. The study is double-blinded, meaning that neither participant nor their doctor will know which treatment group the patient is in.

Who is eligible?

Patients who have a diagnosis of a connective tissue disease with severe and/or progressive ILD associated with the connective tissue disease, and are aged between 18 and 80, should be eligible to apply. This is provided that they have not had previous treatment with rituximab and/or intravenous cyclophosphamide. A full list of eligibility criteria can be found here: https://clinicaltrials.gov/ct2/show/NCT01862926.

The success of this study relies on those eligible coming forward to take part in this investigation, so if this is of interest to you then please email Professor Toby Maher at t.maher@rbht.nhs.uk.


Clinical Surveys

If you would like to take part in a clinical survey, current ones are listed below:

The impact of altered appearance on intimacy

Many people live with conditions that cause disfigurement or lead to changes in their appearance, which can have an impact on their quality of life. In order to provide appropriate support, it is important for doctors, nurses, psychologists and researchers to understand the nature and extent of this impact. At the moment relatively little is known about how visible differences may affect close intimate relationships and what proportion of people with a visible difference experience difficulties in this area.

A series of questionnaires has therefore been developed relating to visible difference, intimacy and sexual activity, being evaluated by others and their related thoughts, feelings, experiences and behaviours. The results of the study will be used to test, refine and shorten the questionnaires to produce a scale that be can be used to find out whether a person is having appearance-related difficulties with intimacy and can also be used for research purposes.

The results of the study will be published to improve healthcare and research professionals' understanding of the area. The results will also be used to test, refine and shorten the questionnaire that we have developed so that we know which questions are most useful for researchers and clinicians so that they may measure the impact of visible differences upon intimate relationships and provide suitable support.

If you are interested in taking part, you can find out more online at tinyurl.com/intimacyCAR or you can contact Nick Sharratt for additional information, if you would like a hard copy of the questionnaires or require any assistance in completing them.

Recruitment period: TBC

Trial location: Home-based (online or paper questionnaire)

Contact: Nick Sharratt, PhD Researcher, Centre for Appearance Research, University of the West of England

E-mail: nick.sharratt@uwe.ac.uk, 0117 328 1891

Future fashion: assistive clothing for Raynaud's

Clothing is an integral part of our lives and yet if you have difficulties putting on or taking off garments, struggle to stay warm or need additional physical support, every day can prove challenging. With Raynaud's it can be difficult to prevent your extremities from getting cold, and research has led to the use of insulated lining and fabric containing silver, which keep more heat in/prevent heat loss and can prevent or reduce the severity of attacks.

To gain a better understanding of the difficulties associated with living with Raynaud's and several other conditions, including diabetes and arthritis, research is being carried out at Nottingham Trent University into supporting these hidden disabilities through textile developments. Lisa Shawgi is a PhD student with a history of designing fashion wear who is currently developing 'assistive/therapeutic' clothing. As someone living with secondary Raynaud's, this is an area of research particularly close to Lisa's heart and she is keen to include the Raynaud's community. Participants will be invited to take part in structured discussions and/or workshop between July 2017 and March 2018. If you are interested in taking part, you can email her or call her on 07507 265332 (Monday to Friday between 9am and 5pm).

Recruitment period: Summer 2017 – February 2018

Trial location: School of Architecture, Design and the Built Environment, Nottingham Trent University

Contact: Lisa Shawgi, PhD Researcher

Email: lisa.shawgi2015@my.ntu.ac.uk, lisashawgi@gmail.com, 07507 265332

Information and education for children whose parents or grandparents have chronic rheumatic conditions

People with long-term rheumatic conditions, like Raynaud's and scleroderma, are often given leaflets to read about their condition. These leaflets try to answer some of the questions they, and their family, might ask.

At the moment there is no information available specifically for the children or grandchildren of people who have long-term rheumatic conditions. We are carrying out a research project to find out if people think it would be a good idea to provide this information for children, written in a way that they would understand. We would also like to know the best way to provide this information, and when. The project is funded by Arthritis Research UK and The Dudley Group NHS Foundation Trust Charitable Fund.

Take the survey

The survey takes five to ten minutes to complete and you can reply anonymously. Some of the questions ask you to write an answer in your own words. When we write a report on this research project we may quote some of these statements. As we do not ask you for your name we will do everything we can to protect your confidentiality. If you do mention someone or a place by name, we will change this or delete it so that it will be very difficult for anyone to identify you.

For further information, contact the research team:

Ms Elizabeth Hale
Department of Rheumatology,
Clinical Research Unit,
North Wing,
The Dudley group of Hospitals NHS Foundation Trust,
Russells Hall Hospital,
Dudley DY1 2HQ

Tel: 01384 456111 extension 3722 (an answer machine is available)

OR

Mr Ben Watkins: 01384 456111 extension 1890.

Recruitment period: TBC

Trial location: Home-based (online)

Contact:

Elizabeth Hale, 01384 456111 extension 3722

Ben Watkins, 01384 456111 extension 1890.


Observational study

Taking part in an observational trial conducted by SRUK and one of our product partners is a great way to get involved in our work and help promote medical understanding of scleroderma and Raynaud's.

The trials are usually run by research groups on behalf of pharmaceutical companies, in conjunction with SRUK. They often consist of an interview and then a follow up study of some sort, for example a diary or a request to trial an activity.

These studies help companies decide if a certain treatment or piece of equipment will work, or if further trial activity is needed. They also help companies spot gaps where further support may be required.

There is often criteria attached to this type of study, but should you qualify you are usually compensated for your time and effort.

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