NCT04489342 Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis
| NCT ID | NCT04489342 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Western Health and Social Care Trust |
| Condition | Axial Spondyloarthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2019-07-01 |
| Primary Completion | 2026-01-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2019-07-01 with a primary completion date of 2026-01-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an observational study using Inertial Measurement Unit (IMU) sensors to measure the effects of biological therapy on spinal mobility and function in axial spondyloarthritis. Participants will undergo MRI scans before and after therapy in parallel to the sensor tests to establish correlation between changes in inflammatory signs and changes in spinal mobility.
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.
Contact & Investigator
Philip Gardiner, MD
PRINCIPAL INVESTIGATOR
Western Health and Social Care Trust
Frequently Asked Questions
Who can join the NCT04489342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Axial Spondyloarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04489342 currently recruiting?
Yes, NCT04489342 is actively recruiting participants. Contact the research team at Dawn.Small@westerntrust.hscni.net for enrollment information.
Where is the NCT04489342 trial being conducted?
This trial is being conducted at Londonderry, United Kingdom.
Who is sponsoring the NCT04489342 clinical trial?
NCT04489342 is sponsored by Western Health and Social Care Trust. The principal investigator is Philip Gardiner, MD at Western Health and Social Care Trust. The trial plans to enroll 20 participants.