The REFLECT Study- Flares in axSpA (REFLECT)

June 30, 2026 updated by: Royal United Hospitals Bath NHS Foundation Trust

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

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

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospitals Bath NHS Foundation Trust
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with axSpA will be recruited from two study sites (RUH and KCH), whilst the RUH (Bath) patient population has limited ethnic and sociodemographic diversity. However, KCH (London) serves a more diverse population of patients.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
axSpA patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported flares
Time Frame: 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.
From enrollment to end of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flare management pathway development & refinement
Time Frame: 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.
From the end of the prospective data collection, for 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal United Hospitals Bath NHS Foundation Trust

Collaborators

King's College Hospital NHS Trust
Royal National Hospital for Rheumatic Diseases

Investigators

  • Principal Investigator: Raj Sengupta, Professor, Royal National Hospital for Rheumatic Diseases (RNHRD) at the Royal United Hospitals Bath NHS Foundation Trust (RUH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Actual)

June 1, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 364763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised data may be shared with researchers in the future to carry out other research into axSpA. This is documented in the participant information sheets and consent forms and specific consent for future use is an option.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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