Can a Tight-Control strategy tame lupus?
NCT ID NCT05714930
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
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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
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About 606 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
14 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Charité - Berlin University of Medicine
RECRUITINGBerlin, 10117, Germany
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Kliniken Essen Mitte, Essen
RECRUITINGEssen, North Rhine-Westphalia, 45136, Germany
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LMU Munich
RECRUITINGMunich, Bavaria, 80336, Germany
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Medical University Hannover
RECRUITINGHanover, Lower Saxony, 30625, Germany
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Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum
RECRUITINGHerne, North Rhine-Westphalia, 44649, Germany
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UKSH Campus Kiel
RECRUITINGKiel, 24105, Germany
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University Clinic Düsseldorf
RECRUITINGDüsseldorf, North Rhine-Westphalia, 40225, Germany
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University Clinic Erlangen
NOT_YET_RECRUITINGErlangen, Bavaria, 91054, Germany
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University Clinic Frankfurt
RECRUITINGFrankfurt am Main, Hesse, 60590, Germany
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University Clinic Freiburg
RECRUITINGFreiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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University Clinic Heidelberg
RECRUITINGHeidelberg, Baden-Wurttemberg, 69120, Germany
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University Clinic Mainz
RECRUITINGMainz, Rhineland-Palatinate, 55131, Germany
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University Clinic Münster
RECRUITINGMünster, North Rhine-Westphalia, 48149, Germany
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University Medical Center TU Dresden
RECRUITINGDresden, Saxony, 01307, Germany
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Other studies related to the condition(s) this trial covers.
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