STRAP Trial

STRAP - Stratification of Biologic Therapies for RA by Pathobiology

Background
The treatment of Rheumatoid Arthritis (RA) has improved considerably over the past 20 years through earlier treatment and, development and use of new medicines called biologics. Whilst biologics have transformed the treatment of RA, around 40% of people treated with biologics still experience a high level of disease activity. This leaves a major unmet need for the health of people with RA, and a considerable health and economic burden to the NHS.

Therefore, the identification of the 40% of people whose RA remains active whilst treated with certain biologics would provide:

a) Better care, by avoiding the use of biologics that are unlikely to help people with RA, and by starting treatment with a more effective biologic medicine earlier.

b) The unnecessary exposure to potentially toxic drugs, and

c) Significant resource and cost savings.

Aim of the STRAP trial
The aim of this study is to investigate whether the most effective choice of biologic medicine for people with RA may be guided by examining the joint tissue (synovial tissue) and, in particular, whether different levels of immune cells (called B cells) within the joint can predict response to treatment.

The ultimate aim is to provide a tailored approach to treatment decisions for people with RA, in order to maximize their potential response to biologic medicines.

What is the STRAP trial looking at?
The study will compare the use of three licensed biological treatments; etanercept, rituximab, and tocilizumab, for people with RA, who are not receiving any benefit from their existing DMARD therapy.DMARD stands for Disease Modifying Anti Rheumatic Drugs, and include medicines, such as methotrexate, sulfasalazine, hydroxychloroquine and leflunomide.

There are no experimental medicines involved in this study. All three medicines are licensed and currently are being used in routine clinical practice to treat people with RA.

What will happen if I decide to take part in the STRAP trial?
With your permission, you will first attend a screening visit (approximately 1 hour), which will assess your eligibility for the study in more detail, which will include:

  • Completing some questionnaires
  • A full physical examination of all your joints
  • Chest X-ray
  • Electrocardiography (ECG)
  • Routine blood test
  • Vital signs including blood pressure, pulse rate, allergies, medical history and urine pregnancy test if you are a woman of child-bearing age.

If the tests show that you are suitable for the study and you agree to take part, you will need to agree to have a biopsy of one of your inflamed joints (usually the knee or wrist joint). This will be done by a doctor and will involve removal of small pieces of tissue that lines the joint (synovial tissue). This will allow the researchers to assign you to one of three treatment groups (etanercept, rituximab or tocilizumab), where you will receive your first treatment and then attend follow-up visits, every 4 weeks, for a total of 48 weeks. During these visits, you will be asked to complete questionnaires and have some tests carried out. These tests may include:

  • Blood tests
  • Additional biopsies (optional)
  • X-rays of your hands and feet
  • Ultrasound assessments

Duration of treatment
48 weeks

Safety
The results from tests given in clinic (such as routine blood tests, ultrasound examination and x-rays) will be documented in your medical records, and used as part of the study to monitor your safety.

This trial is currently taking place at the following NHS hospitals:

  • Mile End Hospital, London - Lead Site
  • University Hospital of Wales, Cardiff
  • Queen Elizabeth Hospital, Birmingham
  • University College London Hospitals, London
  • Freeman Hospital Newcastle, Newcastle-upon-Tyne
  • Glasgow Royal Infirmary, Glasgow
  • Nuffield Orthopaedic Centre, Oxford
  • Southampton Centre for Biomedical Research, Southampton
  • Chapel Allerton Hospital, Leeds
  • Manchester Royal Infirmary, Manchester
  • Southend Hospital, Southend
  • Basildon Hospital, Basildon
  • Guy's and St Thomas' Hospital, London
  • Homerton Hospital, Hometon
  • Addenbrooke's Hospital, Cambridge
  • Royal Free Hospital, London
  • Kings College Hospital, London
  • New Cross Hospital & Cannock Chase Hospital, Wolverhampton

For more background information please click here.

If you would like any further information about the STRAP trial please visit the STRAP website. Alternatively, please contact the Project Manager, Dr Gaye Hadfield, on 0207 882 2904 g.hadfield@qmul.ac.uk

Watch video of STRAP patient talking about the synovial biopsy procedure - https://vimeo.com/210242903/fc698bcca1 

Watch video of clinician talking about how to explain the biopsy to patients - https://vimeo.com/210253080/aa9aff9281