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Lupus study tracks disease activity in over 600 patients

NCT ID NCT06759519

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This completed study looked at 621 people with moderate to severe systemic lupus erythematosus (SLE) in Russia. Researchers collected information about their disease activity and background to better understand the condition. The study did not test any new treatment, but aimed to gather real-world data on how lupus affects patients over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

637 people

The number who actually took part.

Started

Aug 2024

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

It is planned to enrol \~ 600 patients with moderate to severe SLE. Before that approximately 1000 patients with confirmed diagnosis of SLE will be screened (retrospective phase).

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

  • Research Site

    Barnaul, Russia

  • Research Site

    Belgorod, Russia

  • Research Site

    Chelyabinsk, Russia

  • Research Site

    Grozny, Russia

  • Research Site

    Irkutsk, Russia

  • Research Site

    Izhevsk, Russia

  • Research Site

    Kaliningrad, Russia

  • Research Site

    Kazan', Russia

  • Research Site

    Kemerovo, Russia

  • Research Site

    Krasnodar, Russia

  • Research Site

    Makhachkala, Russia

  • Research Site

    Moscow, Russia

  • Research Site

    Murmansk, Russia

  • Research Site

    Nizny Novgorod, Russia

  • Research Site

    Novosibirsk, Russia

  • Research Site

    Omsk, Russia

  • Research Site

    Orenburg, Russia

  • Research Site

    Penza, Russia

  • Research Site

    Perm, Russia

  • Research Site

    Petrozavodsk, Russia

  • Research Site

    Ryazan, Russia

  • Research Site

    Saint-Petrburg, Russia

  • Research Site

    Samara, Russia

  • Research Site

    Saransk, Russia

  • Research Site

    Saratov, Russia

  • Research Site

    Surgut, Russia

  • Research Site

    Tula, Russia

  • Research Site

    Ufa, Russia

  • Research Site

    Ulyanovsk, Russia

  • Research Site

    Volgograd, Russia

  • Research Site

    Yaroslavl, Russia

  • Research Site

    Yekaterinburg, Russia

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