The REFLECT Study- Flares in axSpA

Evidence Based, Patient-led Development of a Novel Axial Spondyloarthritis Flare Management Pathway

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07688174

Acronym

REFLECT

Enrollment

Registered

2026-07-07

Start date

2026-06-01

Completion date

2026-08-31

Last updated

2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondylarthritis (r-axSpA), Axial Spondyloarthritis (AxSpA), Axial Spondyloarthritis, Non-Radiographic, Axial Spondyloarthritis, Radiographic

Keywords

flares, flare management, self-management

Brief summary

Axial spondyloarthritis (axSpA) is a long-term inflammatory condition that affects the spine and sacroiliac joints. People living with axSpA often experience periods when their symptoms suddenly worsen, known as disease "flares." These flares can be painful, unpredictable, and significantly affect daily life, work and psychological wellbeing. Their unpredictable nature can leave people feeling helpless and anxious about when symptoms will return. Research has shown that severe or frequent flares are linked to worse long-term outcomes in axSpA. However, it is difficult for researchers and clinicians to clearly define what a flare is, or to predict when one will happen. There is an unmet, urgent need to improve our understanding and recognition of flares, to enable earlier and more effective intervention, and improve long-term outcomes. This study will explore people's experiences of flares, through a real-time digital flare and symptom diary. Data will be captured digitally from people living with axSpA over 12 months, including symptoms, diet, and lifestyle, self-management strategies and impact of flare on life, work, psychological wellbeing and relationships. Participants will attend clinic at two time points only (once when in flare, once when not in flare), to collect blood (serum) samples for investigation of inflammatory markers. Findings will enable us to define and "map" different flare experiences of people living with axSpA and identify windows of opportunity for intervention and effective management. The results will inform the development of a novel, patient-initiated digital pathway for flare identification and management, which will be discussed and refined in a series of workshops with patients and healthcare professionals. This project will take place in two UK NHS hospitals (specialist rheumatology care settings): The Royal National Hospital for Rheumatic Diseases, Bath and King's College Hospital, London. We anticipate future work to pilot test the pathway and inform potential wider NHS implementation

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients (≥18 years) with a diagnosis of axSpA (non-radiographic or radiographic axSpA). * Access to an email address and electronic device, to participate in data collection. * Capacity to provide informed consent. * Sufficient communicative ability to participate in the research study (must be able to communicate in English). * Patient has experienced at least one (self-reported) flare in the 12-months prior to enrolment.

Exclusion criteria

* Patients \<18 years of age. * Patients with another diagnosis of inflammatory arthritis that is not axial spondyloarthritis. * Living with significant psychiatric morbidity, or if participation may cause distress. * Patient has participated in Project Nightingale (RUH only, 2018 - 2022).

Design outcomes

Primary

Measure	Time frame	Description
Self-reported flares	From enrollment to end of 12 months	To characterise flare manifestations across the heterogeneous spectrum of axSpA disease and treatments and determine how to most effectively self-manage flare to reduce their impact and duration.

Secondary

Measure	Time frame	Description
Flare management pathway development & refinement	From the end of the prospective data collection, for 12 months	To develop a novel, digitally-facilitated patient-initiated flare management pathway for people living with axSpA.

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORRaj Sengupta, Professor

Royal National Hospital for Rheumatic Diseases (RNHRD) at the Royal United Hospitals Bath NHS Foundation Trust (RUH)

Outcome results