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Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia
Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia

NCT06759519

CompletedN/A

Sponsor: AstraZeneca

Conditions: Systemic Lupus Erythematosus

Countries: Russia

This is a multicenter observational retrospective-prospective study consisting of retrospective and prospective phases. Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is retrospective and the 2nd is prospective. The study will involve approximately 50 sites of the Russian Federation; in each site about 20 patients will be recruited. The total planned size of study population will be approximately 1000 patients enrolled to the retrospective phase of the study, from which \~ 600 patients will be enrolled to the prospective phase.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

Inclusion criteria for the retrospective phase are:

1. Patients with the diagnosis of SLE (ICD code: M32) confirmed by medical records;
2. Patients with availability of data of at least one visit to the clinic in the medical records in the last 24 months prior to inclusion;
3. Age ≥ 18 years at the time of last patient's visit to the clinic.

   Additional inclusion criteria for the prospective phase are:
4. Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the prospective phase of the study;
5. Disease activity measured with SLEDAI-2K ≥ 6 despite of standard treatment at the time of inclusion in the prospective phase of the study

Exclusion Criteria:

Exclusion criteria for the retrospective phase are:

1. Regular use of genetically engineered biological drugs for SLE treatment within the last 24 months prior to inclusion;
2. Participation in any interventional trial since the last patient's visit to the clinic;
3. Presence of lupus nephritis class III/IV ± V at the moment of the last patient's visit to the clinic;
4. Presence of neuropsychiatric lupus at the moment of the last patient's visit to the clinic.

   Additional exclusion criteria for the prospective phase are:
5. Current use of genetically engineered biological drugs for SLE treatment;
6. Current participation in any interventional trial;
7. Presence of lupus nephritis Class III/IV ± V at the moment of patient's visit;
8. Presence of neuropsychiatric lupus at the moment of patient's visit;
9. An acute or chronic disease that, in the opinion of the investigator, limits the ability of patient to provide data on his/her health or participate in this study or influence the interpretation of the results.
Locations (32)
  • Barnaul, Russia
  • Belgorod, Russia
  • Chelyabinsk, Russia
  • Grozny, Russia
  • Irkutsk, Russia
  • Izhevsk, Russia
  • Kaliningrad, Russia
  • Kazan', Russia
  • Kemerovo, Russia
  • Krasnodar, Russia
  • Makhachkala, Russia
  • Moscow, Russia
  • Murmansk, Russia
  • Nizny Novgorod, Russia
  • Novosibirsk, Russia
  • Omsk, Russia
  • Orenburg, Russia
  • Penza, Russia
  • Perm, Russia
  • Petrozavodsk, Russia
  • Ryazan, Russia
  • Saint-Petrburg, Russia
  • Samara, Russia
  • Saransk, Russia
  • Saratov, Russia
  • Surgut, Russia
  • Tula, Russia
  • Ufa, Russia
  • Ulyanovsk, Russia
  • Volgograd, Russia
  • + 2 more on CT.gov