Validation of Patient E-tool to Measure Systemic Lupus Activity

NCT05763225 | Completed

• 1 other identifier: nZein
• Study Type: observational
• Target: 450
• Locations: 3 countries
• Sites: 31

Brief 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.

Conditions

Lupus Erythematosus, Systemic

Keywords

Patient-reported outcomes; Disease activity; SLEDAI; Patient empowerment; Lupus Erythematosus Systemic; SLEDAI-P; LUPIN

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life evaluation via the 36-Item Short Form Health Survey (SF-36)

  through study completion, an average of 6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This survey will be distributed to the entire French population affected by lupus (metropolitan and overseas territories). The study is anonymous from the beginning and there will be no way to trace the identity of the participants.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+): lead
• Hometrix Health SAS: collaborator

Study Sites (31)

Médecine interne - Centre hospitalier de la Côte Basque

Bayonne, 64109, France

Location

CHU Minjoz

Besançon, 25030, France

Location

CHU Bordeaux

Bordeaux, 33076, France

Location

Service de Médecine interne et maladies infectieuses (Sud) CHU de Bordeaux-GH Sud - Hôpital Haut-Lévêque

Bordeaux, 33604, France

Location

CHU de Clermont-Ferrand - Hôpital Gabriel Montpied Médecine Interne

Clermont-Ferrand, 63000, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

CHU Dijon Bourgogne - Hôpital François Mitterrand

Dijon, 21000, France

Location

Et service de médecine interne - CHU Réunion site Nord, St Denis

La Réunion, 97400, France

Location

Hospices Civils de Lyon

Lyon, 69003, France

Location

Hopital de la Croix Rousse - Lyon, Service de médecine Interne

Lyon, 69004, France

Location

Médecine Interne - Hôpital Saint Joseph Saint Luc

Lyon, 69007, France

Location

Hôpitaux Universitaires de Marseille Conception - Médecine interne, Immunologie et Immunologie clinique

Marseille, 13005, France

Location

Service de Médecine Interne de l'Hôpital de la Timone

Marseille, 13005, France

Location

Service de médecine interne - Hôpital Nord

Marseille, 13915, France

Location

Service de Médecine Interne Hôpital Robert Schuman

Metz, 57070, France

Location

CHU de Nancy, Hôpital Brabois

Nancy, 54111, France

Location

Service de médecine interne et immunologie clinique CHU de Nancy - Hôpitaux de Brabois

Nancy, 54511, France

Location

CHU de Nantes Hôtel Dieu- Centre de compétences maladies systémiques et auto-immunes rares

Nantes, 44000, France

Location

Hôpital Saint-Louis - Service de Médecine Interne, Maladies Systémiques

Paris, 75010, France

Location

Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix

Paris, 75013, France

Location

Hôpital Tenon - Service de dermatologie, médecine vasculaire et allergologie

Paris, 75020, France

Location

Hôpital Bicêtre - Service de Rhumatologie

Paris, 94270, France

Location

Service de médecine interne CHU de Poitiers

Poitiers, 86000, France

Location

Hopital Robert Debre Chu Reims

Reims, 51092, France

Location

Département de Médecine Interne du Pr.BENHAMOU CHU DE ROUEN

Rouen, 76000, France

Location

Strasbourg University Hospital

Strasbourg, 67000, France

Location

Hôpital civil - Immunologie Clinique et Médecine Interne

Strasbourg, 67091, France

Location

Service de Médecine Interne & Immunologie Clinique Hôpital Bretonneau CHRU de Tours

Tours, 37044, France

Location

CH de Valence - Valence, Service de médecine interne

Valence, 26000, France

Location

Centre Hospitalier de la Basse Terre

Basse-Terre, 97100, Guadeloupe

Location

Service de Rhumatologie - Médecine Interne 5D CHU de Martinique - Hôpital P. Zobda-Quitman

Martinique, 97261, Martinique

Location

Related Publications (20)

• 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.

  PMID: 25172239 BACKGROUND

• 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.

  PMID: 15161983 BACKGROUND

• 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.

  PMID: 11296953 BACKGROUND

• 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.

  PMID: 35206945 BACKGROUND

• 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.

  PMID: 20039413 BACKGROUND

• 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.

  PMID: 21296404 BACKGROUND

• 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.

  PMID: 21958603 BACKGROUND

• 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.

  PMID: 3271336 BACKGROUND

• 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.

  PMID: 9133936 BACKGROUND

• 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.

  PMID: 11752513 BACKGROUND

• 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.

  PMID: 7728402 BACKGROUND

• 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.

  PMID: 12810926 BACKGROUND

• 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.

  PMID: 25742757 BACKGROUND

• 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.

  PMID: 15814577 BACKGROUND

• 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.

  PMID: 8923374 BACKGROUND

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

  PMID: 11838846 BACKGROUND

• 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.

  PMID: 19892750 BACKGROUND

• 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.

  PMID: 24739325 BACKGROUND

• 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.

  PMID: 22041578 BACKGROUND

• 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.

  PMID: 24418306 BACKGROUND

Related Links

• Promoter website

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Patient Participation

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

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

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 10, 2023
• Study Start: February 9, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 15, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

GU (1); MA (1); FR (29)