Axial Spondyloarthritis (AxSpA)REFLECTNCT07688174
The REFLECT Study- Flares in axSpA
An observational study of Axial Spondyloarthritis (AxSpA) and Axial Spondyloarthritis, Non-Radiographic, run by Royal United Hospitals Bath NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis (AxSpA), Axial Spondyloarthritis, Non-Radiographic, Axial Spondyloarthritis, Radiographic
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jun 2026to 31 Aug 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG
King's College Hospital NHS Foundation Trust
London, SE5 9RS
About this study
Official title: 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.
Read more
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
- Conditions
- Axial Spondyloarthritis (AxSpA), Axial Spondyloarthritis, Non-Radiographic, Axial Spondyloarthritis, Radiographic, Axial Spondylarthritis (r-axSpA)
- Keywords
- flares, flare management, self-management
- Medical subject headings
- Axial Spondyloarthritis, Non-Radiographic Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| axSpA patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported flares
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.
Measured: From enrollment to end of 12 months
Secondary outcomes (1)
Flare management pathway development & refinement
To develop a novel, digitally-facilitated patient-initiated flare management pathway for people living with axSpA.
Measured: From the end of the prospective data collection, for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Axial Spondyloarthritis (AxSpA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal National Hospital for Rheumatic Diseases, King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Raj Sengupta, Professor, Principal investigator, Royal National Hospital for Rheumatic Diseases (RNHRD) at the Royal United Hospitals Bath NHS Foundation Trust (RUH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688174
- Sponsor's protocol ID
- 364763
- Acronym
- REFLECT
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Vasileiou K, Barnett J, Thorpe S, Young T. Characterising and justifying sample size sufficiency in interview-based studies: systematic analysis of qualitative health research over a 15-year period. BMC Med Res Methodol. 2018 Nov 21;18(1):148. doi: 10.1186/s12874-018-0594-7.
PubMed 30463515Ondrejcakova L, Gregova M, Bubova K, Senolt L, Pavelka K. Serum biomarkers and their relationship to axial spondyloarthritis associated with inflammatory bowel diseases. Autoimmun Rev. 2024 Mar;23(3):103512. doi: 10.1016/j.autrev.2023.103512. Epub 2023 Dec 31.
PubMed 38168574Hellman U, Lejon K, Do L, Geijer M, Baraliakos X, Witte T, Forsblad-d'Elia H. Immunological biomarkers in patients with radiographic axial spondyloarthritis, an exploratory longitudinal Swedish study. Mod Rheumatol. 2024 Dec 25;35(1):134-143. doi: 10.1093/mr/roae039.
PubMed 38706167Liu D, Xie Y, Tu L, Wen X, Lv Q, Liu B, Yang M, Wu X, Zheng X, Luo X, Zhou L, Wu J, Liu B, Wang K, Jin O, Wang X, Qin J, Wu L, Zhao D, He D, He S, Huang W, Ye S, Zhou H, Wu J, Wang Y, Liu S, Li Z, Tan Z, Xu C, Wang Y, Zheng D, Zhan F, Lin C, Wen Y, Wu J, Wen S, Liao Z, Shen Y, Yang K, Gu J. A guideline on biomarkers in the diagnosis and evaluation in axial spondyloarthritis. Front Immunol. 2024 Oct 30;15:1394148. doi: 10.3389/fimmu.2024.1394148. eCollection 2024.
PubMed 39539543Reilly E, Fisher C, Sengupta R. FRI0193 Prognostic markers in axial spondyloarthritis (PROMISE) - cross sectional evaluation of serum biomarkers in axspa, mechanical back pain and healthy controls. Annals of the Rheumatic Diseases. 2018;77(Suppl 2):637-.
Carter SM, Shih P, Williams J, Degeling C, Mooney-Somers J. Conducting Qualitative Research Online: Challenges and Solutions. Patient. 2021 Nov;14(6):711-718. doi: 10.1007/s40271-021-00528-w. Epub 2021 Jun 11.
PubMed 34114170Gandrup J, Selby DA, Dixon WG. Classifying Self-Reported Rheumatoid Arthritis Flares Using Daily Patient-Generated Data From a Smartphone App: Exploratory Analysis Applying Machine Learning Approaches. JMIR Form Res. 2024 May 14;8:e50679. doi: 10.2196/50679.
PubMed 38743480O'Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, Yardley L, Hoddinott P. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019 Aug 15;9(8):e029954. doi: 10.1136/bmjopen-2019-029954.
PubMed 31420394Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
PubMed 34593508Barnett R, Ng S, Sengupta R. Understanding flare in axial spondyloarthritis: novel insights from daily self-reported flare experience. Rheumatol Adv Pract. 2021 Nov 15;5(3):rkab082. doi: 10.1093/rap/rkab082. eCollection 2021.
PubMed 34926981Aouad K, Gossec L. Defining and managing flares in axial spondyloarthritis. Curr Opin Rheumatol. 2022 Jul 1;34(4):195-202. doi: 10.1097/BOR.0000000000000883. Epub 2022 Jun 9.
PubMed 35699318Molto A, Gossec L, Meghnathi B, Landewe RBM, van der Heijde D, Atagunduz P, Elzorkany BK, Akkoc N, Kiltz U, Gu J, Wei JCC, Dougados M; ASAS-FLARE study group. An Assessment in SpondyloArthritis International Society (ASAS)-endorsed definition of clinically important worsening in axial spondyloarthritis based on ASDAS. Ann Rheum Dis. 2018 Jan;77(1):124-127. doi: 10.1136/annrheumdis-2017-212178. Epub 2017 Oct 16.
PubMed 29038299van Gaalen FA, Navarro-Compan V, Baraliakos X, van den Bosch F, Gensler LS, Hmamouchi I, Landewe R, Machado PM, Marzo-Ortega H, Rodriguez VR, Poddubnyy D, Ramiro S, van der Heijde D. ASAS recommendations on reporting axial spondyloarthritis clinical trials. Ann Rheum Dis. 2025 Nov;84(11):1770-1778. doi: 10.1016/j.ard.2025.07.017. Epub 2025 Sep 6.
PubMed 40915940