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Lupus Erythematosus, SystemicOPTIMISENCT05763225

Validation of Patient E-tool to Measure Systemic Lupus Activity

An observational study of Lupus Erythematosus, Systemic, run by Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+) at 31 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lupus Erythematosus, Systemic
How many people
450 participants
Where
31 sitesin 3 countries
Study dates
9 Feb 2023to 15 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

31 sites in 3 countries.

31 sites in 3 countries

France29 sites

  • Médecine interne - Centre hospitalier de la Côte Basque

    Bayonne, 64109

  • CHU Minjoz

    Besançon, 25030

  • CHU Bordeaux

    Bordeaux, 33076

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

    Bordeaux, 33604

  • CHU de Clermont-Ferrand - Hôpital Gabriel Montpied Médecine Interne

    Clermont-Ferrand, 63000

  • Hopital Louis Pasteur

    Colmar, 68024

  • CHU Dijon Bourgogne - Hôpital François Mitterrand

    Dijon, 21000

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

    La Réunion, 97400

  • Hospices Civils de Lyon

    Lyon, 69003

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

    Lyon, 69004

  • Médecine Interne - Hôpital Saint Joseph Saint Luc

    Lyon, 69007

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

    Marseille, 13005

  • Service de Médecine Interne de l'Hôpital de la Timone

    Marseille, 13005

  • Service de médecine interne - Hôpital Nord

    Marseille, 13915

  • Service de Médecine Interne Hôpital Robert Schuman

    Metz, 57070

  • CHU de Nancy, Hôpital Brabois

    Nancy, 54111

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

    Nancy, 54511

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

    Nantes, 44000

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

    Paris, 75010

  • Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix

    Paris, 75013

  • Hôpital Tenon - Service de dermatologie, médecine vasculaire et allergologie

    Paris, 75020

  • Hôpital Bicêtre - Service de Rhumatologie

    Paris, 94270

  • Service de médecine interne CHU de Poitiers

    Poitiers, 86000

  • Hopital Robert Debre Chu Reims

    Reims, 51092

  • Département de Médecine Interne du Pr.BENHAMOU CHU DE ROUEN

    Rouen, 76000

  • Strasbourg University Hospital

    Strasbourg, 67000

  • Hôpital civil - Immunologie Clinique et Médecine Interne

    Strasbourg, 67091

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

    Tours, 37044

  • CH de Valence - Valence, Service de médecine interne

    Valence, 26000

Other trials in France

Guadeloupe1 site

  • Centre Hospitalier de la Basse Terre

    Basse-Terre, 97100

Other trials in Guadeloupe

Martinique1 site

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

    Martinique, 97261

Other trials in Martinique

About this study

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

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.

Read the detailed 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.

Keywords
Patient-reported outcomes, Disease activity, SLEDAI, Patient empowerment, Lupus Erythematosus Systemic, SLEDAI-P, LUPIN
Medical subject headings
Lupus Erythematosus, Systemic, Patient Participation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: through study completion, an average of 6 months

Secondary outcomes (1)

  1. 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)

    Measured: through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start9 Feb 2023
  3. Primary completion1 Jun 2024
  4. Study completion15 Jun 2024

Resources

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
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763225
Sponsor's protocol ID
nZein
Acronym
OPTIMISE
Status last verified
Jul 2024
First submitted
9 Feb 2023
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25172239

  • 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.

    PubMed 15161983

  • 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.

    PubMed 11296953

  • 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.

    PubMed 35206945

  • 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.

    PubMed 20039413

  • 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.

    PubMed 21296404

  • 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.

    PubMed 21958603

  • 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.

    PubMed 3271336

  • 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.

    PubMed 9133936

  • 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.

    PubMed 11752513

  • 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.

    PubMed 7728402

  • 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.

    PubMed 12810926

  • 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.

    PubMed 25742757

  • 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.

    PubMed 15814577

  • 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.

    PubMed 8923374

Questions about this trial

What is this clinical trial studying?

An observational study of Lupus Erythematosus, Systemic, run by Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+) at 31 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France, Guadeloupe, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05763225, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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