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Can a Tight-Control strategy tame lupus?

NCT ID NCT05714930

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a 'treat-to-target' approach—where doctors adjust treatment every 6 weeks to aim for remission—works better than usual care for people with lupus. About 606 participants who are not in remission will be followed for 120 weeks. The goal is to see if this strategy reduces long-term organ damage and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
treat-to-target strategy (tight control with frequent visits and treatment adjustments)
What this could lead to
If successful, this approach could become a standard way to manage lupus, helping more patients reach remission and prevent long-term organ damage.
What could go wrong
This is a strategy trial, not testing a new drug, so benefits may be modest. Results depend on how well doctors and patients follow the plan, and the study is still recruiting.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 606 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Patients with SLE according to validated classification criteria * Age at least 18 years * Not in a stage of remission due to 1. Clinical SLEDAI \> 0 AND/OR 2. GC dosage above 5 mg prednisone equivalent per day AND/OR 3. Physician global assessment ≥ 0.5 on a visual analogue scale (VAS) from 0 to 3 * Fluent German language skills * Written informed consent Exclusion Criteria: * Participation in other interventional trial(s) * Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason. Examples could be: * Life-threatening SLE manifestations that require intensive care treatment * Active life-threatening diseases other than SLE * Active malignancies * Acute and chronic infections that do not allow the intensification of immunosuppressive treatment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Charité - Berlin University of Medicine

    RECRUITING

    Berlin, 10117, Germany

  • Kliniken Essen Mitte, Essen

    RECRUITING

    Essen, North Rhine-Westphalia, 45136, Germany

  • LMU Munich

    RECRUITING

    Munich, Bavaria, 80336, Germany

  • Medical University Hannover

    RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum

    RECRUITING

    Herne, North Rhine-Westphalia, 44649, Germany

  • UKSH Campus Kiel

    RECRUITING

    Kiel, 24105, Germany

  • University Clinic Düsseldorf

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • University Clinic Erlangen

    NOT_YET_RECRUITING

    Erlangen, Bavaria, 91054, Germany

  • University Clinic Frankfurt

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • University Clinic Freiburg

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • University Clinic Heidelberg

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • University Clinic Mainz

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

  • University Clinic Münster

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • University Medical Center TU Dresden

    RECRUITING

    Dresden, Saxony, 01307, Germany

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