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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT04956484 Completed - Clinical trials for Lupus Erythematosus, Systemic

Belimumab In Early Systemic Lupus Erythematosus

Start date: September 1, 2021
Phase: Phase 4
Study type: Interventional

To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6 months).

NCT ID: NCT04951427 Recruiting - Clinical trials for Systemic Lupus Erythematosus

PRediction Of Flares In Lupus With autoantibodiEs and Chemokines

PROFILE
Start date: September 15, 2021
Phase:
Study type: Observational

Rationale: Systemic lupus erythematosus (SLE) is a chronic relapsing-remitting autoimmune disease with a wide range of clinical manifestations affecting several organs. Although the management of lupus patients has improved in the last years, accurate models for predicting disease progression are lacking. Objective: To prospectively evaluate the predictive value of a combination of chemokines, MMPs/TIMPs, and autoantibody levels for predicting flares in patients with SLE Study design: prospective, observational single centre cohort study, conducted at the department of Rheumatology and Clinical Immunology of the UMC Utrecht Study population: Adult patients with SLE (according to EULAR/ACR criteria) under control in the UMC Utrecht. Intervention (if applicable): n/a Main study parameters/endpoints: - Profile of autoantibodies and chemokines in visits previous to recorded flares, compared to visits previous to no recorded flares. Risk calculations will be made using areas under the curve (AUC) for both individual markers as multivariate analysis - Changes in the profile of autoantibodies and chemokines in patients with lower reported quality of life measured by LupusQoL questionnaire, compared to previous visits of the same patient. - Changes in titer levels of autoantibodies before and after start of biological treatment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: this is an observational study; the burden for patients is esteemed to be low. For some patients who regularly attend the outpatient clinic yearly, the four-times a year visits during two years will be more frequent, including more frequent blood sampling, compared to standard care. Furthermore, more blood will be drawn per sampling, compared to standard care.

NCT ID: NCT04942314 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Practice of Treat-to-target on Pediatric Systemic Lupus Erythematosus: a Two-center Retrospective Study

Start date: July 1, 2021
Phase:
Study type: Observational

Treat to target (T2T) strategies have proved to be useful in several chronic disorders, including Rheumatoid Arthritis. In systemic lupus erythematosus (SLE), T2T strategy has been proposed in order to control disease activity, improve health-related quality of life, and reduce morbidity and mortality. Remission would be the main target, but a low disease activity state (LDAS) could be an acceptable alternative. However, due to SLE protean manifestations, the operational definitions of both remission and LDAS are still in progress. This clinical trial would like to assess the clinical value of T2T strategy in the treatment of children with SLE, optimize the treatment of children with SLE, andimprove the prognosis.

NCT ID: NCT04931563 Active, not recruiting - Clinical trials for Active Systemic Lupus Erythematosus

Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)

Start date: September 13, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in Asian participants with active systemic lupus erythematosus (SLE).

NCT ID: NCT04925934 Completed - Clinical trials for Lupus Erythematosus, Systemic

Study of VIB7734 for the Treatment of Moderate to Severely Active SLE

RECAST SLE
Start date: June 24, 2021
Phase: Phase 2
Study type: Interventional

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.

NCT ID: NCT04908865 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)

Start date: October 21, 2021
Phase: Phase 4
Study type: Interventional

This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.

NCT ID: NCT04908280 Completed - Clinical trials for Discoid Lupus Erythematosus

Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus

Start date: May 4, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE)

NCT ID: NCT04907175 No longer available - Clinical trials for System; Lupus Erythematosus

Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)

Start date: n/a
Phase:
Study type: Expanded Access

This protocol is part of an FDA Individual Patient Expanded Access IND. This study is to be conducted according to US and International Standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Hope Biosciences Stem Cell Research Foundation policies and procedures.

NCT ID: NCT04902807 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation

ATRACTion
Start date: June 2021
Phase:
Study type: Observational

The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity/inflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomics, epigenomics, proteomics, metagenomics, metabolomics and lipidomics).

NCT ID: NCT04895696 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Start date: October 11, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.