NCT05458622Active, not recruitingPhase 3
3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erithematosus Study Protocol
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
The natural history of Systemic lupus erythematosus (SLE) is characterized by relapses or flares alternated with periods of remission. Flares are associated with accrual of organ damage independently of other risk factors, both contributing to a considerable morbidity. No useful biomarker is currently available to predict which patients with a quiescent disease are at risk of flare. The 3TR project (funded by the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 831434, and supported by European Union's Horizon 2020 research and innovation programme and EFPIA) is a transdisciplinary consortium that primary aims at identifying biosignatures as predictors of response and non-response to therapy in seven different autoimmune, allergic and inflammatory diseases, including SLE. 3TR will perform a longitudinal multi-dimensional molecular analysis in patients with these diseases. A molecular profiling approach is a modern and innovative way to investigate and stratify heterogeneous diseases on the basis of their common biomolecular pathways. The main hypothesis of the 3TR project is that data obtained from multiomic analysis across the seven different diseases will identify shared biological pathways that better predict the response or non-response to therapy despite their differences in terms of clinical phenotypes and pathogenetic mechanisms. Therefore patients from multiple European centers participating in 3TR will be recruited for a longitudinal clinical follow-up and collections of several samples that will be used to perform multi-omic analysis.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 13 Jun 2022
- Start date
- 29 Nov 2022
- Primary completion date
- Nov 2026
- Lead sponsor
- University Hospital, Brest
- Diseases
- Lupus (SLE)
- NCT number
- NCT05458622
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 25
- From 29 Nov 2022 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Initiation or intensification of immunosuppressive therapy or a prednisone equivalent dose of \> 10 mg/day within 30 days prior to baseline;
Other
- Pregnancy and/or breastfeeding;
- Unable or unaware to participate to the study.
Who the study is looking for
- Age at the time of inclusion ≥ 18 years;
- Able to consent and agree to participate to the study.
- Diagnosis of SLE according to the EULAR/ACR criteria; BILAG C, D or E only;
- No restriction regarding current or previous therapies, except for hydroxychloroquine (HCQ) or chloroquine treatment which should be administered unless contraindicated or documented intolerance in the past.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 01- CHU Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.