No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
606 (estimated)
Sponsor
Heinrich-Heine University, Duesseldorf · Other
Who this trial is looking for
This trial is looking for adults with systemic lupus erythematosus (SLE) who are not in remission. Participants will receive a specific treatment plan with regular check-ins to help manage their condition over a period of 120 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with systemic lupus erythematosus.
I am 18 years or older.
I am not in remission due to my SLE symptoms.
I can speak and understand German.
I am willing to provide written consent.
You may not be able to join if
I am participating in another interventional trial.
I have a disease that makes me unsuitable for this study.
I have life-threatening SLE symptoms that need intensive care.
I have any active life-threatening diseases besides SLE.
I have an active cancer.
I have infections that prevent me from increasing immunosuppressive treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Multicenter, national, two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target (T2T) strategy in in systemic lupus erythematosus (SLE). 14 centers will be randomized 1:1 to T2T or standard of care. Per arm 303 patients with SLE who are not in remission will be included and receive either tight control with 6-weekly visits with the aim to reach remission or SoC wit…
Multicenter, national, two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target (T2T) strategy in in systemic lupus erythematosus (SLE). 14 centers will be randomized 1:1 to T2T or standard of care. Per arm 303 patients with SLE who are not in remission will be included and receive either tight control with 6-weekly visits with the aim to reach remission or SoC with control visits and treatment adjustment according to the physicians discretion. Study duration is 120 weeks using damage accrual and Health related Quality of Life as major outcomes.
Trial Locations
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Eligibility Criteria
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 ana…
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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