Scleroderma Clinical Research Study Enrolment

Date: Sun 4th September 2016

This information is intended for residents of the UK

Now Enrolling Patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc) also called Scleroderma

Have you or someone you know been diagnosed with diffuse cutaneous systemic sclerosis? Would you/they be interested in participating in a clinical research study?

What is a clinical research study?

A clinical research study is a carefully supervised research investigation, often performed in people before a medication is available to the general public, for the condition studied.

Clinical research studies are performed according to government regulations, which help to protect the safety and rights of study participants.

Why are clinical research studies conducted?

Clinical research studies are conducted for a variety of reasons, including:

·To find out whether a study medication, therapy or device appears to be effective for treating a symptom or disease in humans, either compared with no treatment or with alternative therapies, if these are available.

·To investigate any risks associated with a study medication, therapy or device when it is used for the treatment of the symptom or disease being considered

·To find new treatments and improve upon existing treatments

What is diffuse cutaneous systemic sclerosis (dcSSc)?

Diffuse cutaneous systemic sclerosis is a form of scleroderma which can affect the internal organs along with the skin above the elbows and knees.

Bayer AG dcSSc Clinical Research study

A Clinical Research Study is being performed by Bayer AG in 16 countries, including the UK, to investigate a potential new treatment for adults affected by Diffuse Cutaneous Systemic Sclerosis (dcSSc).

Although not licensed for the treatment of dcSSc, the study medicine is licensed for the treatment of other conditions.

Main Study Objective

This study investigates the effectiveness of the study medicine vs a dummy tablet (placebo). It is not known whether the study medicine will have any benefits in dcSSc patients or what all the risks of treatment are. Patients who take part in the study are allocated randomly (by chance) to a treatment group. Each patient who takes part has a 50% chance of receiving placebo and a 50% chance of receiving the study medicine.

Study Length

There is a 52-week main study phase during which patients take placebo or the study medicine.

Who may qualify for this study?

In order to be able to participate in the clinical research study it is important that a patient's dcSSc condition meets certain criteria. Any patient who wishes to take part will be assessed to find out whether they are eligible.

Main Inclusion Criteria

In order to take part in the clinical research study, a patient must meet the following criteria:

Age: Be a man or woman aged 18 years and older.

Diagnosis: Have a diagnosis of diffuse cutaneous systemic sclerosis (dcSSc).

Disease Duration: Early dcSSc = Less than 18 months since first non−Raynaud's symptom.

mRSS: Low skin score = A patient's skin is not too severely affected, as determined by a low score obtained using a specific measurement tool (the modified Rodnan skin score, mRSS, study range 10 and 22 mRSS).

Main Exclusion Criteria

In order to take part in the clinical research study a patient must not meet any of the following criteria:

Age: Be below the age of 18.

General exclusions: Have a diagnosis of limited cutaneous systemic sclerosis (rather than diffuse cutaneous systemic sclerosis).

Exclusions related to lung disease:

·Have diagnosed Pulmonary Hypertension (a condition associated with high blood pressure in the blood vessels in the lungs)

Other inclusion and exclusion criteria also apply and will be discussed with you if you are interested in taking part.This study is open for recruitment & being performed at 7 Scleroderma Specialist centres across England & Scotland.

Specialist Physicians & Centres participating in Study:

7 UK Sites:

Prof. C.Denton: Royal Free, London

Tel: 020 7794 0432

Research Nurse: Yvonne Tan: 020 7317 7544

Dr. B. Griffiths: Freeman Hospital, Newcastle

Tel: 0191 213 7978

Research Nurse: Julie Norris: 0191 213 7166

Prof. A. Herrick: Salford Royal, Manchester

Tel: 0161 206 4616

Research Nurse: Nicola Harwood: 0161 206 6077

Dr. M. Anderson: Aintree Hospital, Liverpool

Tel: 0151 529 8497

Research Nurse: Helen Frankland: 0151 529 5894

Dr. J. Pauling: Royal National Hospital for Inflammatory Diseases, Bath

Tel: 01225 463223

Research Nurse: Andrea Dowden: 01225 473453

Dr. E. Derrett-Smith: Queen Elisabeth Hospital, Birmingham

Tel: 0121 371 6837

Research Nurse: Joanne Dasgin: 01213 713170 ext 13209

Dr. C. Baines: Nine Wells Hospital, Dundee

Tel: 01382 633883

Research Nurse: Shona Murray: 01382 633883

If you are interested in participating in this study or would like to obtain further information, please discuss this with your GP or dcSSc/scleroderma physician. Alternatively, you may call the number of the appropriately located study site above.

A response does not indicate any commitment to take part in the study.

Reasonable travel/subsistence/accomodation expenses will be refunded for patient & carer upon production of receipts, where appropriate, however no payments will be made in relation to patient/carer time

This text & the study itself has been approved by a Reseach Ethics Committee

For more information please see: Identifier: NCT02283762.