Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

Launched by WESTERN HEALTH AND SOCIAL CARE TRUST · Jul 24, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how well biological therapy helps people with axial spondyloarthritis, a type of arthritis that mainly affects the spine. The researchers will use special sensors to measure how well participants can move their spine and how much their condition improves after treatment. Participants will also have MRI scans before and after the therapy to see how the treatment affects inflammation in their body and its connection to spinal mobility.

To be eligible for the study, participants must be at least 18 years old and under 80, have a confirmed diagnosis of axial spondyloarthritis, and meet specific criteria for receiving biological therapy. They should be able to understand and fill out questionnaires and must agree to take part in the study by signing a consent form. Unfortunately, people with certain health issues, recent surgeries, or who are pregnant cannot participate. Those who join can expect to undergo sensor tests and MRI scans while helping to advance our understanding of this condition and its treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria.
• • 2. Age ≥18 years old and \<80 years.
• • 3. Fulfilment of local criteria for biologic therapy for axSpA.
• • 4. The subjects should be able to read, write, understand and complete study questionnaires.
• • 5. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
• Exclusion Criteria:
• • 1. Safety contra-indication for biologic drug therapy.
• • 2. Severely restricted hip movement (less than 20 degrees rotation in either hip).
• • 3. History of previous clinical (symptomatic) vertebral fracture.
• • 4. History of previous spinal surgery.
• • 5. History of previous hip replacement surgery.
• • 6. Major scoliosis deformity (in the opinion of the investigator).
• • 7. Safety contra-indication for MRI assessment.
• • 8. Previous biologic agent within 2 months.
• • 9. Pregnant or breast-feeding women.