The REFLECT Study- Flares in axSpA

NCT07688174 | Active Not Recruiting DMC

• 1 other identifier: 364763
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

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

Keywords

flares; flare management; self-management

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to end of 12 months

Secondary Outcomes (1)

• Flare management pathway development & refinement

  From the end of the prospective data collection, for 12 months

Study Arms (1)

axSpA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead
• Royal National Hospital for Rheumatic Diseases: collaborator
• King's College Hospital NHS Trust: collaborator

Study Sites (2)

Royal United Hospitals Bath NHS Foundation Trust

Bath, BA1 3NG, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (13)

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• Liu 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.

  PMID: 39539543 BACKGROUND

• Reilly 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-.

  BACKGROUND

• 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.

  PMID: 34114170 BACKGROUND

• Gandrup 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.

  PMID: 38743480 BACKGROUND

• O'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.

  PMID: 31420394 BACKGROUND

• Skivington 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.

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• Barnett 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.

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• Aouad 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.

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• Molto 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.

  PMID: 29038299 BACKGROUND

• van 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.

  PMID: 40915940 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (approximately 50ml of blood per sample - about four tablespoons) will be processed to obtain the serum samples, de-identified (using the participants unique Study ID). Serum samples will undergo biomarker evaluation (e.g., MMP-3, IL-6, serum calprotectin (9-12) at index and one in-person flare visit only, if feasible)

MeSH Terms

Conditions

Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Raj Sengupta, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: June 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (2)