Systemic Lupus ErythematosusLupus-BestNCT05714930
LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus
A study testing Treat-to-target as a new treatment concept in people with Systemic Lupus Erythematosus, run by Heinrich-Heine University, Duesseldorf at 14 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Treat-to-target as a new treatment concept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 14 sitesGermany
- Study dates
- 12 Dec 2023to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with SLE according to validated classification criteria
- Age at least 18 years
- Not in a stage of remission due to
- Clinical SLEDAI > 0 AND/OR
- GC dosage above 5 mg prednisone equivalent per day AND/OR
- Physician global assessment ≥ 0.5 on a visual analogue scale (VAS) from 0 to 3
- Fluent German language skills
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Germany14 sites, 14 recruiting
- Recruiting
Charité - Berlin University of Medicine
Berlin, 10117
Tobias Alexander, MD
- Recruiting
University Medical Center TU Dresden
Dresden, Saxony, 01307
Martin Aringer, MD
- Recruiting
University Clinic Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Matthias Schneider, MD
- Not yet recruiting
University Clinic Erlangen
Erlangen, Bavaria, 91054
Ricardo Grieshaber-Bouyer, MD
- Recruiting
Kliniken Essen Mitte, Essen
Essen, North Rhine-Westphalia, 45136
Gamal Chehab, MD
- Recruiting
University Clinic Frankfurt
Frankfurt am Main, Hesse, 60590
Michaela Köhm, MD
- Recruiting
University Clinic Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Stephanie Finzel, MD
- Recruiting
Medical University Hannover
Hanover, Lower Saxony, 30625
Torsten Witte, MD
- Recruiting
University Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Hanns Martin Lorenz, MD
- Recruiting
Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum
Herne, North Rhine-Westphalia, 44649
Ioana Andreica, MD
- Recruiting
UKSH Campus Kiel
Kiel, 24105
Sorwe Mojtahed Poor, MD
- Recruiting
University Clinic Mainz
Mainz, Rhineland-Palatinate, 55131
Andreas Schwarting, MD
- Recruiting
LMU Munich
Munich, Bavaria, 80336
Hendrik Schulze-Koops, MD
- Recruiting
University Clinic Münster
Münster, North Rhine-Westphalia, 48149
Martin Kriegel, MD
About this study
Official title: LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial
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.
Read the detailed description
This is a 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) on damage progression and health related quality of life (HRQoL). The study centers will be assigned 1:1 to standard of care (SoC) or remission, defined as the absence of clinical disease activity (clinical SLEDAI =0) AND prednisolone ≤5mg/day AND physician global assessment (PGA) <0.5 on a VAS 0-3. Patient with SLE > 18 years of age who are not in remission will be eligible.
Per arm, 303 patients will be included. Intervention centers receive a standardized training on T2T and shared decision making (SDM). In the intervention centers, patients not on target enter a phase of tight control with 6-weekly visits and treatment adjustments (at least 4 visits) or until remission is reached and maintained. Patients in remission are reassessed every 12 weeks. In case of flare, they can re-enter tight control based on SDM. In the SoC arm, patients receive 3- to 6-monthly controls and treatment adjustments according to the physician's discretion. Study duration is 120 weeks using damage accrual and HRQoL as major outcomes.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Treat-to-target as a new treatment concept
- Keywords
- Treat-to-target, shared decision making
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treat-to-target as a new treatment conceptOther
After trial initiation, the study personnel in the intervention centers will receive a training on T2T and shared decision making (SDM). Patients in the intervention centers will receive 6-weekly visits for at least 24 weeks with therapeutic adjustments to achieve remission. In case of stable remission for 6 weeks at week 24, the patients switch to 12-weekly visits until the end of the trial at week 120. In case of flare, the patient switches to 6-weekly visits for 24 consecutive weeks. Pharmaceutical treatment decisions will be guided by current treatment standards and will be taken in accordance with SDM between patients and treating physicians.
| Study group | Role | What they receive |
|---|---|---|
| Treat-to-target | Experimental | T2T will be implemented based on shared decision-making (SDM), tight control and remission as a validated treatment target (disease activity score clinical SLEDAI-2k = 0 \& glucocorticoids (GC) ≤ 5 mg prednisolone equivalent \& physician global assessment (PGA 0-3) < 0.5 ± immunomodulatory therapy); All intervention centers will receive T2T/SDM trainings. Patients not meeting their target criterion at study entry or at any time during the trial will be included in a tight control T2T loop of 24 weeks with assessments every 6 weeks to reach the target by adjustments of their immunomodulatory treatments. Patients in target will be assessed every 12 weeks as it is standard in clinical routine care. Receives: Other: Treat-to-target as a new treatment concept |
| Standard of Care | No intervention | In the standard of care (SoC) arm, patients receive 3-to 6-monthly controls and treatment adjustments according to their physician's discretion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Damage accrual
Damage is defined as irreversible disease associated damage, captured by the Systemic Lupus International Collaborating Clinics/ American College of Rheumatology (SLICC/ACR-) damage index (SDI). The SDI is a validated tool to assess irreversible damage that has occurred since onset of lupus. It ranges from 0 (no damage) to 44 (highest achievable damage and worst outcome). Primary endpoint is the difference of damage accrued over 120 weeks between the two arms after 120 weeks.
Measured: week 120
Secondary outcomes (16)
Health Related Quality of Life (HRQoL)
Health related quality of life (HRGoL) is measured by the Short Form 36 questionnaire (SF-36), an established, patient-reported health survey. It contains 36 items in 8 sections. The lower the score, the higher the level of disability, "0"equalling maximum, a score of 100 no disability.
Defined as the difference in Health Related Quality of Life between the two arms at week 120. HRQoL is measured by the disease independent Short Form 36 questionnaire (SF-36).
Measured: week 120
Disease activity reported by physicians
Defined as the difference in Systemic Lupus Erythematodes Disease Activity Index 2000 (SLEDAI-2K) between the two arms at week 120. The SLEDAI-2K is a validated measuring tool for disease activity of SLE. Specific manifestations in 9 organ systems are evaluated. There are 24 descriptors included. 16 items are clinical, 8 are based solely on laboratory test results. They are weighted differently based on severity. The final score ranges from 0 (no disease activity) to a maximum of 105 points (highest disease activity).
Measured: week 120
Patient-reported disease activity
Defined as the difference in Systemic Lupus Activity Questionnaire (SLAQ) between the two arms at week 120. The SLAQ asks the patient to rate disease activity on a scale of 0-10 over the past 3 months. It consists of 24 items in 9 organs/systems. Regarding disease activity, 0 is defined as no problem, 1 mild, 2 moderate and 3 severe disease activity. The respective numeric rating scale ranges from 0 = "no activity", to 10 = "most activity".
Measured: week 120
Cumulative time in remission
Remission is defined as
- Clinical SLEDAI-2K = 0 AND
- Physician global assessment (VAS 0-3) < 0.5 AND
- Prednisone < 5mg/d The Systemic Lupus Erythematodes Disease Activity Index 2000 (SLEDAI-2K) is a validated measuring tool for disease activity of SLE. Specific manifestations in 9 organ systems are evaluated. There are 24 descriptors included. 16 items are clinical, 8 are based solely on laboratory test results. They are weighted differently based on severity. The final score ranges from 0 (no disease activity) to a maximum of 105 points (highest disease activity). I Physician Global Assessment is a clinical tool to assess disease activity from the clinician's perspective (rater). It is measured on a Visual Analogous Scale from 0 (no disease activity) to 3 (most severe disease activity). Assessed will be the cumulative time in remission between the two arms over 120 weeks.
Measured: 120 weeks
Cumulative number of new organ manifestations
Defined as the difference in number of new organ manifestations according to the Systemic Lupus Erythematodes Disease Activity Index 2000 (SLEDAI-2K) between the two arms over 120 weeks. The SLEDAI-2K is a validated measuring tool for disease activity of SLE. Specific manifestations in 9 organ systems are evaluated. There are 24 descriptors included. 16 items are clinical, 8 are based solely on laboratory test results. They are weighted differently based on severity. The final score ranges from 0 (no disease activity) to a maximum of 105 points (highest disease activity).
Measured: 120 weeks
Time to achieve remission
Defined as the mean difference in time to achieve remission defined as
- Clinical SLEDAI-2K = 0 AND
- Physician global assessment (VAS 0-3) < 0.5 AND
- Prednisone < 5mg/d between the two arms over 120 weeks. The Systemic Lupus Erythematodes Disease Activity Index 2000 (SLEDAI-2K) is a validated measuring tool for disease activity of SLE. Specific manifestations in 9 organ systems are evaluated. There are 24 descriptors included. 16 items are clinical, 8 are based solely on laboratory test results. They are weighted differently based on severity. The final score ranges from 0 (no disease activity) to a maximum of 105 points (highest disease activity). Physician Global Assessment is a clinical tool to assess disease activity from the clinician's perspective (rater). It is measured on a Visual Analogous Scale from 0 (no disease activity) to 3 (most severe disease activity).
Measured: 120 weeks
Cumulative glucocorticoid (GC) dosage at week 120
Difference in cumulative glucocorticoid dosage between the two arms at week 120.
Measured: week 120
Percentage of patients refusing remission as target
Defined as the difference in the percentage of patients refusing remission as target between the two arms over 120 weeks.
Measured: 120 weeks
Percentage of physicians refusing remission as target
Defined as the difference in the percentage of physicians refusing remission as target over 120 weeks.
Measured: 120 weeks
Drug adherence
Defined as the difference in adherence between the two arms over 120 weeks. Adherence is measured by the Medication Adherence Report Scale (MARS-5).
MARS-5 consists of 5 items designed to reflect patient reports of nonadherence. It ranges from 5 to 25 with higher scores indicating a higher level of adherence.
Measured: 120 weeks
Fatigue
Defined as the difference in fatigue between the two arms over 120 weeks. Fatigue is measured by the Functional Assessment of Chronic Illness Therapy (FACIT) The FACIT assesses self-reported fatigue and its impact on daily activities and function. It encompasses 13 items ranging from 0 to 52 with lower scores expressing more fatigue and lower quality of life.
Measured: 120 weeks
Fatigue
Defined as the difference in fatigue between the two arms over 120 weeks. Fatigue is measured by the Scale and Fatigue Scale for Motor and Cognitive Functions (FSMC). The FSMC consists of 20 items on 2 subscales (cognitive and motoric fatigue) which the patient reports on a 5-point-likert scale. A maximum of 50 points can be achieved for each subscale and 100 points in total. A patient without any cognitive or motoric fatigue will achieve 20 points. ≥ points in total represent low-level of fatigue, ≥ 34 points severe fatigue.
Measured: 120 weeks
Work productivity
Defined as the difference in work productivity between the two arms over 120 weeks. Work productivity is measured by the Work Productivity Activity Impairment Questionnaire for Lupus (WPAI:Lupus V2.0). The WPAI: Lupus V2.0 is a measurement tool for work productivity, adapted for SLE-patients. It consists of 6 items grouped in 4 domains. Outcomes for each domain are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity at work.
Measured: 120 weeks
Evaluation of shared decision-making (SDM) by patients
Shared decision making will be assessed by the 9 item Shared Decision Making - Questionnaire (SDM-Q-9) questionnaire for patients over 120 weeks.
The SDM-Q-9 is a patient reported questionnaire, assessing if shared decision making (SDM) occurred in the last consultation of the medical provider from the viewpoint of the patient. It consists of 2 open-ended and 9 closed questions. Each closed question is represented by a statement rated on a 6-point balanced scale ranging from 0 (= completely disagree), to 5 (= completely agree). The sum (total score) of the nine items is expressed on a scale ranging from 0 to 45. The higher the score, the greater is the level of SDM perceived.
Measured: 120 weeks
Evaluation of shared decision-making by physicians
Shared decision making (SDM) will be assessed by the Doctor-SDM-Questionnaire (SDM-Q-Doc) for physicians over 120 weeks. The Shared decision making Q-Doc questionnaire evaluates if SDM occurred in the last consultation from the viewpoint of the physician. It is structured analogous the SDM-Q-9 and ranged from 0 to 45. The higher the score, the greater is the level of SDM perceived.
Measured: 120 weeks
Evaluation of health utilities
The short form 6-dimensional utility index (SF-6D) is a measuring tool derived from 11 items in 6 dimensions of the Short Form -36. It ranges from = (dead) to 1 (full health).
Measured: 120 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start12 Dec 2023
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, national, two-armed cluster-randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 606 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, German Diabetes-Center, Leibniz-Institut in Düsseldorf, Lupus Erythematodes-Selbsthilfegemeinschaft e.V.
- Responsible party
- Sponsor
- Investigators
- Matthias Schneider, MD, Principal investigator, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714930
- Sponsor's protocol ID
- LUPUS-BEST
- Acronym
- Lupus-Best
- Status last verified
- Jun 2026
- First submitted
- 10 Jan 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05714930
- Acronym / sponsor ID
- Lupus-Best / LUPUS-BEST
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Treat-to-target, shared decision making
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 606 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, German Diabetes-Center, Leibniz-Institut in Düsseldorf, Lupus Erythematodes-Selbsthilfegemeinschaft e.V.
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 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) on damage progression and health related quality of life (HRQoL). The study centers will be assigned 1:1 to standard of care (SoC) or remission, defined as the absence of clinical disease activity (clinical SLEDAI =0) AND prednisolone ≤5mg/day AND physician global assessment (PGA) <0.5 on a VAS 0-3. Patient with SLE > 18 years of age who are not in remission will be eligible.
Per arm, 303 patients will be included. Intervention centers receive a standardized training on T2T and shared decision making (SDM). In the intervention centers, patients not on target enter a phase of tight control with 6-weekly visits and treatment adjustments (at least 4 visits) or until remission is reached and maintained. Patients in remission are reassessed every 12 weeks. In case of flare, they can re-enter tight control based on SDM. In the SoC arm, patients receive 3- to 6-monthly controls and treatment adjustments according to the physician's discretion. Study duration is 120 weeks using damage accrual and HRQoL as major outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, national, two-armed cluster-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treat-to-target | Experimental | Other: Treat-to-target as a new treatment conceptT2T will be implemented based on shared decision-making (SDM), tight control and remission as a validated treatment target (disease activity score clinical SLEDAI-2k = 0 \& glucocorticoids (GC) ≤ 5 mg prednisolone equivalent \& physician global assessment (PGA 0-3) < 0.5 ± immunomodulatory therapy); All intervention centers will receive T2T/SDM trainings. Patients not meeting their target criterion at study entry or at any time during the trial will be included in a tight control T2T loop of 24 weeks with assessments every 6 weeks to reach the target by adjustments of their immunomodulatory treatments. Patients in target will be assessed every 12 weeks as it is standard in clinical routine care. |
| Standard of Care | No intervention | –In the standard of care (SoC) arm, patients receive 3-to 6-monthly controls and treatment adjustments according to their physician's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with SLE according to validated classification criteria
- Age at least 18 years
- Not in a stage of remission due to
- Fluent German language skills
- Written informed consent
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treat-to-target as a new treatment conceptAfter trial initiation, the study personnel in the intervention centers will receive a training on T2T and shared decision making (SDM). Patients in the intervention centers will receive 6-weekly visits for at least 24 weeks with therapeutic adjustments to achieve remission. In case of stable remission for 6 weeks at week 24, the patients switch to 12-weekly visits until the end of the trial at week 120. In case of flare, the patient switches to 6-weekly visits for 24 consecutive weeks. Pharmaceutical treatment decisions will be guided by current treatment standards and will be taken in accordance with SDM between patients and treating physicians. | Other | Treat-to-target |
Primary outcome
Damage accrual
Time frame: week 120
Damage is defined as irreversible disease associated damage, captured by the Systemic Lupus International Collaborating Clinics/ American College of Rheumatology (SLICC/ACR-) damage index (SDI). The SDI is a validated tool to assess irreversible damage that has occurred since onset of lupus. It ranges from 0 (no damage) to 44 (highest achievable damage and worst outcome). Primary endpoint is the difference of damage accrued over 120 weeks between the two arms after 120 weeks.
16 secondary outcomes
Health Related Quality of Life (HRQoL)
Time frame: week 120
Disease activity reported by physicians
Time frame: week 120
Patient-reported disease activity
Time frame: week 120
Cumulative time in remission
Time frame: 120 weeks
Cumulative number of new organ manifestations
Time frame: 120 weeks
Time to achieve remission
Time frame: 120 weeks
Cumulative glucocorticoid (GC) dosage at week 120
Time frame: week 120
Percentage of patients refusing remission as target
Time frame: 120 weeks
Percentage of physicians refusing remission as target
Time frame: 120 weeks
Drug adherence
Time frame: 120 weeks
Fatigue
Time frame: 120 weeks
Fatigue
Time frame: 120 weeks
Work productivity
Time frame: 120 weeks
Evaluation of shared decision-making (SDM) by patients
Time frame: 120 weeks
Evaluation of shared decision-making by physicians
Time frame: 120 weeks
Evaluation of health utilities
Time frame: 120 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Schneider, MD principal investigator
Heinrich-Heine University, Duesseldorf
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treat-to-target as a new treatment concept in people with Systemic Lupus Erythematosus, run by Heinrich-Heine University, Duesseldorf at 14 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias Schneider, MD (0211 81 17817, lupus-best@rheumanet.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Damage accrual (time frame: week 120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.