Advanced metrology in axial spondyloarthritis (ANDROID)
Research type
Research Study
Full title
An investigation into the responsiveness of Inertial Measurement Unit (IMU) sensor-based tests in measuring changes in spinal mobility and function in axial spondyloarthritis patients treated with biologic drugs
IRAS ID
270559
Contact name
Pedro Machado
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2019/11/53 , UCL Data Protection Reference Number
Duration of Study in the UK
2 years, 6 months, 5 days
Research summary
Spondyloarthritis (SpA) a group of diseases sharing genetic, molecular, immunological, clinical and imaging features. Symptoms include pain, stiffness & loss of function. Some patients lose all of their spinal mobility, progressing to complete and permanent fusion of the spine. Spinal mobility has been recognised to be one of the most important outcomes to measure in SpA clinical trials. It is also recommended that clinical trials should include at least one validated outcome measure of physical function.
This is a prospective observational study in patients with Axial SpA. Recruitment will be over a 2-year period. The study is comprised of 2 visits: a pre-treatment visit taking place 0-8 weeks prior to first dose of biologic therapy and the post-treatment visit taking place 3-6 months after the first dose of biologic therapy. Patients participating in the MRI sub-study will have an MRI scan of the whole spine sacro-iliac joints before treatment and 3-6 months after biologic treatment commences.
This study is part of a three-year project to validate the use of sensors to measure spinal mobility. The study is not testing the efficacy or safety of the sensors. The sensors we will be using are approved for use in spinal mobility. The main objective of the project is to develop and validate a sensor based IMU-ASMI recording the spinal range of movement in clinic. This study is designed to assess the responsiveness to treatment of the IMU-ASMI and the functional tests. The clinic-based spinal mobility tests will also be carried out in parallel studies in 4 other centres so that by the end of the project we are aiming to have over 90 IMU-ASMI data sets before and after treatment.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0122
Date of REC Opinion
5 Jun 2020
REC opinion
Further Information Favourable Opinion