Validation of Patient E-tool to Measure Systemic Lupus Activity

Lupus Erythematosus, Systemic Clinical Trial

— OPTIMISE  

Official title:

Validation of the SLEDAI-P/LUPIN Self-questionnaire Completed by the Patient to Measure the Activity of the Systemic Lupus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763225
• Other study ID #: nZein
• Status: Recruiting
• Start date: February 9, 2023
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+)
• Contact: Marianne Rivière, AFL+ Chairwoman
• Phone: +33 6 28 67 08 19
• Email: optimise.lupusplus[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Validation of a self-questionnaire (SLEDAI-P/LUPIN) completed by the patient to measure the activity of the systemic lupus, in order to improve the patient's empowerment.

Description:

Systemic Lupus Erythematosus (SLE) is a rare and chronic autoimmune disease. Disease activity (DA) is marked by remissions, spontaneous relapses or induced by therapeutic modifications. SLE exposes to serious complications requiring close medical follow-up, but flares cannot be predicted and often do not coincide with medical consultations. SLE DA is measured during a consultation using the SLEDAI tool, but cannot be completed by patients. There is therefore high at stake to develop tools allowing patients to measure DA, predict flares and subsequently tailor the medical follow-u to each patient. Using the same framework as a previous nationwide study related to COVID-19 impact (EPICURE survey), we aim to develop and validate, in collaboration with the French national Lupus Reference Centers and Hometrix Health, a patient-tailored tool (SLEDAI-P/LUPIN). SLEDAI-P/LUPIN was designed by expert lupulogist and patients. It is available as a paper questionnaire and a smartphone app. It consists of simple patient-oriented questions allowing numerical score calculation. In order to validate the SLEDAI-P/LUPIN, we will recruit 500 SLE patients who satisfy the 2019 ACR/EULAR classification criteria. All patients will complete the self-questionnaire and have a follow-up consultation with a clinician within 7 days. The validity of the SLEDAI-P self-questionnaire will be assessed by calculating the correlation between SLEDAI-P/LUPIN and the clinical SLEDAI-2K provided by the clinician (blindly of the SLEDAI-P/LUPIN results). We will also collect information about the quality of life via the SF-36 questionnaire to evaluate if the SLEDAI-P/LUPIN predicts patient-reported outcome measures. The results of this survey will permit the validation of the SLEDAI-P/LUPIN as a self-questionnaire carried by the patient. The development of self-administrated disease activity questionnaires such as the SLEDAI-P/LUPIN may allow to better tailor the treatment and follow-up of SLE patients, and empower SLE patients for the control and management of their disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

Clinical diagnosis of systemic lupus Patient residing in Metropolitan France or in the french Ultra-Marine Departments and Territories Patient who has both completed the SLEDAI-P/LUPIN, SF-12 and been assessed by a specialist via the SLEDAI-2K within 15 days Exclusion criteria : Non-lupus patient/participant Patient residing outside France Patient who has not completed the SLEDAI-P/LUPIN OR has not been assessed by a specialist via the SLEDAI-2K within 15 days

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Locations

Country	Name	City	State
France	Médecine interne - Centre hospitalier de la Côte Basque	Bayonne
France	CHU Minjoz	Besançon
France	CHU Bordeaux	Bordeaux
France	Service de Médecine interne et maladies infectieuses (Sud) CHU de Bordeaux-GH Sud - Hôpital Haut-Lévêque	Bordeaux
France	CHU de Clermont-Ferrand - Hôpital Gabriel Montpied Médecine Interne	Clermont-Ferrand
France	Hopital Louis Pasteur	Colmar
France	CHU Dijon Bourgogne - Hôpital François Mitterrand	Dijon
France	Et service de médecine interne - CHU Réunion site Nord, St Denis	La Réunion
France	Hopital de la Croix Rousse - Lyon, Service de médecine Interne	Lyon
France	Hospices Civils de Lyon	Lyon
France	Médecine Interne - Hôpital Saint Joseph Saint Luc	Lyon
France	Hôpitaux Universitaires de Marseille Conception - Médecine interne, Immunologie et Immunologie clinique	Marseille
France	Hôpitaux Universitaires de Marseille Conception - Médecine interne, Immunologie et Immunologie clinique	Marseille
France	Service de médecine interne - Hôpital Nord	Marseille
France	Service de Médecine Interne de l'Hôpital de la Timone	Marseille
France	Service de Médecine Interne Hôpital Robert Schuman	Metz
France	CHU de Nancy, Hôpital Brabois	Nancy
France	Service de médecine interne et immunologie clinique CHU de Nancy - Hôpitaux de Brabois	Nancy
France	CHU de Nantes Hôtel Dieu- Centre de compétences maladies systémiques et auto-immunes rares	Nantes
France	Hôpital Bicêtre - Service de Rhumatologie	Paris
France	Hôpital Saint-Louis - Service de Médecine Interne, Maladies Systémiques	Paris
France	Hôpital Tenon - Service de dermatologie, médecine vasculaire et allergologie	Paris
France	Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix	Paris
France	Service de médecine interne CHU de Poitiers	Poitiers
France	Hopital Robert Debre Chu Reims	Reims
France	Département de Médecine Interne du Pr.BENHAMOU CHU DE ROUEN	Rouen
France	Hôpital civil - Immunologie Clinique et Médecine Interne	Strasbourg
France	Strasbourg University Hospital	Strasbourg
France	Service de Médecine Interne & Immunologie Clinique Hôpital Bretonneau CHRU de Tours	Tours
France	CH de Valence - Valence, Service de médecine interne	Valence
Guadeloupe	Centre Hospitalier de la Basse Terre	Basse-Terre
Martinique	Service de Rhumatologie - Médecine Interne 5D CHU de Martinique - Hôpital P. Zobda-Quitman	Martinique

Sponsors (2)

Lead Sponsor	Collaborator
Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+)	Hometrix Health SAS

Countries where clinical trial is conducted

France,  Guadeloupe,  Martinique, 

References & Publications (20)

Agmon-Levin N, Mosca M, Petri M, Shoenfeld Y. Systemic lupus erythematosus one disease or many? Autoimmun Rev. 2012 Jun;11(8):593-5. doi: 10.1016/j.autrev.2011.10.020. Epub 2011 Oct 25. — View Citation

Arnaud L, Fagot JP, Mathian A, Paita M, Fagot-Campagna A, Amoura Z. Prevalence and incidence of systemic lupus erythematosus in France: a 2010 nation-wide population-based study. Autoimmun Rev. 2014 Nov;13(11):1082-9. doi: 10.1016/j.autrev.2014.08.034. Epub 2014 Aug 27. — View Citation

Ceccarelli F, Perricone C, Massaro L, Cipriano E, Alessandri C, Spinelli FR, Valesini G, Conti F. Assessment of disease activity in Systemic Lupus Erythematosus: Lights and shadows. Autoimmun Rev. 2015 Jul;14(7):601-8. doi: 10.1016/j.autrev.2015.02.008. Epub 2015 Mar 2. — View Citation

Cervera R, Doria A, Amoura Z, Khamashta M, Schneider M, Guillemin F, Maurel F, Garofano A, Roset M, Perna A, Murray M, Schmitt C, Boucot I. Patterns of systemic lupus erythematosus expression in Europe. Autoimmun Rev. 2014 Jun;13(6):621-9. doi: 10.1016/j.autrev.2013.11.007. Epub 2014 Jan 10. — View Citation

Ehrenstein MR, Conroy SE, Heath J, Latchman DS, Isenberg DA. The occurrence, nature and distribution of flares in a cohort of patients with systemic lupus erythematosus: a rheumatological view. Br J Rheumatol. 1995 Mar;34(3):257-60. doi: 10.1093/rheumatology/34.3.257. — View Citation

Gladman D, Urowitz M, Fortin P, Isenberg D, Goldsmith C, Gordon C, Petri M. Systemic Lupus International Collaborating Clinics conference on assessment of lupus flare and quality of life measures in SLE. Systemic Lupus International Collaborating Clinics Group. J Rheumatol. 1996 Nov;23(11):1953-5. No abstract available. — View Citation

Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91. — View Citation

Gordon C, Sutcliffe N, Skan J, Stoll T, Isenberg DA. Definition and treatment of lupus flares measured by the BILAG index. Rheumatology (Oxford). 2003 Nov;42(11):1372-9. doi: 10.1093/rheumatology/keg382. Epub 2003 Jun 16. — View Citation

Isenberg DA, Garton M, Reichlin MW, Reichlin M. Long-term follow-up of autoantibody profiles in black female lupus patients and clinical comparison with Caucasian and Asian patients. Br J Rheumatol. 1997 Feb;36(2):229-33. doi: 10.1093/rheumatology/36.2.229. — View Citation

Isenberg DA, Rahman A, Allen E, Farewell V, Akil M, Bruce IN, D'Cruz D, Griffiths B, Khamashta M, Maddison P, McHugh N, Snaith M, Teh LS, Yee CS, Zoma A, Gordon C. BILAG 2004. Development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus. Rheumatology (Oxford). 2005 Jul;44(7):902-6. doi: 10.1093/rheumatology/keh624. Epub 2005 Apr 6. — View Citation

Luijten KM, Tekstra J, Bijlsma JW, Bijl M. The Systemic Lupus Erythematosus Responder Index (SRI); a new SLE disease activity assessment. Autoimmun Rev. 2012 Mar;11(5):326-9. doi: 10.1016/j.autrev.2011.06.011. Epub 2011 Sep 18. — View Citation

Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D, Brunetta PG. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010 Jan;62(1):222-33. doi: 10.1002/art.27233. — View Citation

Mosca M, Tani C, Aringer M, Bombardieri S, Boumpas D, Brey R, Cervera R, Doria A, Jayne D, Khamashta MA, Kuhn A, Gordon C, Petri M, Rekvig OP, Schneider M, Sherer Y, Shoenfeld Y, Smolen JS, Talarico R, Tincani A, van Vollenhoven RF, Ward MM, Werth VP, Carmona L. European League Against Rheumatism recommendations for monitoring patients with systemic lupus erythematosus in clinical practice and in observational studies. Ann Rheum Dis. 2010 Jul;69(7):1269-74. doi: 10.1136/ard.2009.117200. Epub 2009 Nov 5. — View Citation

Ravirajan CT, Rowse L, MacGowan JR, Isenberg DA. An analysis of clinical disease activity and nephritis-associated serum autoantibody profiles in patients with systemic lupus erythematosus: a cross-sectional study. Rheumatology (Oxford). 2001 Dec;40(12):1405-12. doi: 10.1093/rheumatology/40.12.1405. — View Citation

Scherlinger M, Zein N, Gottenberg JE, Riviere M, Kleinmann JF, Sibilia J, Arnaud L. Difficulties and Psychological Impact of the SARS-CoV-2 Pandemic in Patients with Systemic Lupus Erythematosus: A Nationwide Patient Association Study. Healthcare (Basel). 2022 Feb 9;10(2):330. doi: 10.3390/healthcare10020330. — View Citation

Stoll T, Sutcliffe N, Mach J, Klaghofer R, Isenberg DA. Analysis of the relationship between disease activity and damage in patients with systemic lupus erythematosus--a 5-yr prospective study. Rheumatology (Oxford). 2004 Aug;43(8):1039-44. doi: 10.1093/rheumatology/keh238. Epub 2004 May 25. — View Citation

Stone JH. BLISS! Lupus learns its lessons. Lancet. 2011 Feb 26;377(9767):693-4. doi: 10.1016/S0140-6736(10)61546-2. Epub 2011 Feb 4. No abstract available. — View Citation

Symmons DP, Coppock JS, Bacon PA, Bresnihan B, Isenberg DA, Maddison P, McHugh N, Snaith ML, Zoma AS. Development and assessment of a computerized index of clinical disease activity in systemic lupus erythematosus. Members of the British Isles Lupus Assessment Group (BILAG). Q J Med. 1988 Nov;69(259):927-37. — View Citation

van Vollenhoven RF, Mosca M, Bertsias G, Isenberg D, Kuhn A, Lerstrom K, Aringer M, Bootsma H, Boumpas D, Bruce IN, Cervera R, Clarke A, Costedoat-Chalumeau N, Czirjak L, Derksen R, Dorner T, Gordon C, Graninger W, Houssiau F, Inanc M, Jacobsen S, Jayne D, Jedryka-Goral A, Levitsky A, Levy R, Mariette X, Morand E, Navarra S, Neumann I, Rahman A, Rovensky J, Smolen J, Vasconcelos C, Voskuyl A, Voss A, Zakharova H, Zoma A, Schneider M. Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. Ann Rheum Dis. 2014 Jun;73(6):958-67. doi: 10.1136/annrheumdis-2013-205139. Epub 2014 Apr 16. — View Citation

Wang C, Mayo NE, Fortin PR. The relationship between health related quality of life and disease activity and damage in systemic lupus erythematosus. J Rheumatol. 2001 Mar;28(3):525-32. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statistical correlation between the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) questionnaire and the patients reported outcome SLEDAI for Patient / LUpus Patient INdex (SLEDAI-P/LUPIN)	Patients reported outcome score versus clinical SLEDAI score, Maximum delay between the two surveys is 7 days. score 0-105 (the highest score represents the highest disease activity)	through study completion, an average of 6 months
Secondary	Quality of life evaluation via the 36-Item Short Form Health Survey (SF-36)	The SF-36 has 8 subscales (Physical activity; Limitations due to physical condition; Each of the 8 summary scores is linearly transformed on a scale from 0 (negative to health) to 100 (positive to health)Perceived health; Vitality; Life and relationships with others; Limitations due to psychological condition; Psychological health; Change in perceived health)	through study completion, an average of 6 months

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