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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT04098055 Completed - Clinical trials for Musculoskeletal Pain

Effect of Insoles in Patients With Systemic Lupus Erythematosus

EISLE
Start date: November 2, 2019
Phase: N/A
Study type: Interventional

Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement.

NCT ID: NCT04089930 Completed - Lupus Erythematosus Clinical Trials

Long-term Immunogenicity of a Live Herpes Zoster Vaccine in Systemic Lupus Erythematosus (SLE) Patients

Start date: June 1, 2020
Phase:
Study type: Observational

A recent randomized controlled trial (RCT) from our group has demonstrated safety and immune response (both humoral and cell-mediated) of the live-attenuated herpes zoster (HZ) vaccine (Zostavax) in stable systemic lupus erythematosus (SLE) patients with a previous history of HZ or varicella infection. An important research question is whether the immunogenicity of the HZ vaccine in SLE patients is long-lasting. There is no information in the literature regarding the long-term immunogenicity and safety of Zostavax in SLE patients. This prompts the current extension study which is planned to evaluate the long-term immunogenicity and efficacy of Zostavax in our original patient cohort.

NCT ID: NCT04082416 Completed - Clinical trials for Systemic Lupus Erythematosus

Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

Start date: October 16, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE.

NCT ID: NCT04077684 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial

Start date: September 10, 2019
Phase: Phase 2
Study type: Interventional

The management of active systemic lupus erythematosus (SLE) is challenging due to the heterogeneous nature of the disease and lack of specific treatment. Current treatment regimens mainly rely on corticosteroids and immunosuppressive agents which are associated with substantial adverse effects including various infections. Therefore, there is an unmet need for new therapies with better efficacy and less adverse effects. Defective IL-2 production contributes to the unbalanced immune system in SLE. Previous short term open-labelled trials showed that low-dose IL-2 was efficient and tolerated in active SLE. It was suggested that low-dose IL-2 treatment promoted regulatory T cells (Treg) and inhibited T helper 17 cells (Th17) and follicular helper T cells (Tfh). The immunological rebalancing was associated with the induction of remission in SLE patients. To establish that which low doses of IL-2 would be more efficacious and safe in active SLE, we carried out a multi-center, randomized, double-blind, placebo-controlled trial of three doses of IL2 (0.2 MIU, 0.5 MIU or 1 MIU) versus placebo.

NCT ID: NCT04060888 Withdrawn - Clinical trials for Lupus Erythematosus, Systemic

A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus

Start date: July 14, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ustekinumab in Chinese participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard-of-care treatments.

NCT ID: NCT04058028 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

Start date: February 19, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.

NCT ID: NCT04046172 Not yet recruiting - Periodontitis Clinical Trials

Treatment of Periodontal Disease in Systemic Lupus Erythematosus

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The primary objective of this study is to: Part 1 - Baseline Comparisons The primary objective of Part 1 is to: Investigate the association between SLE and a measures of vascular health (brachial artery flow-mediated dilatyation) in patients with Systemic Lupus Erythematosus (SLE) and a healthy periodontium compared to patients with SLE and Periodontitis (PD) Part 2 - Pilot Randomized Clinical Trial To assess the effect of Periodontal Treatment (PT) on the endothelial function in a population of patients suffering from SLE and PD. Secondary Secondary objectives include: Part 1 - Baseline Comparisons The secondary objectives of Part 1 are to investigate the association of: - Inflammatory biomarkers in saliva and blood and periodontal status in patients with SLE and PD and those with SLE and a healthy periodontium - The oral microbiome using plaque analysis and periodontal status in patients with SLE and PD and those with SLE and a healthy periodontium Part ParPa Part 2 - Pilot Randomized Controlled Trial Evaluate the effect of PT on biomarkers of SLE disease severity/progression in a population of patients suffering from SLE and PD. Evaluate the effect of PT on the B cell panel in a population of patients suffering from SLE and PD. Evaluate effect of PT on the systemic inflammatory and oxidative profile of a population of patients suffering from SLE and PD. Evaluate effect of PT on skin lesions in a population of patients suffering from SLE and PD.

NCT ID: NCT04037293 Active, not recruiting - Atherosclerosis Clinical Trials

Premature Atherosclerosis in Systemic Lupus Erythematosus

PASLE
Start date: May 1, 2013
Phase:
Study type: Observational [Patient Registry]

Patients with SLE have increased rates of atherosclerosis, while the risk factors for atherosclerosis in those patients were not fully revealed. This study is an observational study to investigate the natural process and risk factors for atherosclerosis based on a Chinese SLE cohort. Carotid intima media thickness (CIMT) and brachial-ankle pulse wave velocity (baPWV) will be measured for each patient at baseline and 5-year follow-up. Blood tests including cholesterol levels, fasting plasma glucose levels and etc. will also be performed.

NCT ID: NCT04035265 Recruiting - Hand Rheumatism Clinical Trials

Application of MRI for Musculoskeletal Involvement in SLE

RMNLES
Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Articular involvement can reach up to 95% within the chronic multisystemic manifestations of SLE (1). Originally, a non-erosive pattern of articular inflammation was described, but the emergence of more sensitive imaging techniques, such as MRI (2, 3), show synovitis, erosions (hand: 47-48%, carpus 82-84% in SLE; and hand: 18%, carpus 97% in healthy individuals), bone oedema (hand: 4-5%, carpus 13-16% in SLE; and 0% in healthy individuals) and tenosynovitis (hand 47%, carpus 79%; not evaluated in healthy individuals) in patients with SLE (4, 5). Nowadays, a specific validated pattern of articular involvement associated with this disease does not yet exist, although it has begun to be studied. This research tries to evaluate the presence, frequency and distribution of inflammatory articular manifestations in SLE (erosions, bone oedema, synovitis or tenosynovitis) using MRI (6), with the objective of trying to establish a specific pattern for this disease, if it exists, that can shorten the diagnostic process. Moreover, it tries to characterise, if they exist, clinical differences between various patient groups according to their articular involvement.

NCT ID: NCT04032496 Not yet recruiting - Clinical trials for Lupus Erythematosus, Systemic

Contemplation-Based Intervention and Health Outcomes RCT in Lupus Patients

Start date: January 2020
Phase: N/A
Study type: Interventional

The objective of this study is to test the efficacy of an innovative contemplative-based and caregiver-inclusive intervention can modify pathogenic processes in systemic lupus erythematosus (SLE) compared to a psychoeducation-based intervention. Contemplative techniques such as meditation, mindfulness and yoga may have an impact on the disease burden and may decrease psychological distress, increase self-regulation capabilities, and reduce pain. It is also well documented that social relationships moderate physical health. Incorporating patients' caregivers may strengthen their relationships and thereby improve their health and well-being. It is anticipated that the successful outcome of the mindfulness-based intervention described in this proposal will provide the basis for a new and effective contemplative-based and caregiver-inclusive therapy for SLE and other rheumatic diseases. Although we expect our mindfulness-based intervention to outperform our psychoeducation intervention, we note that the psychoeducation intervention is much closer to treatment as usual (especially insofar as many lupus patients are provided no psychosocial intervention whatever), and to that degree can reasonably be considered our best initial point of comparison. In practice, most patients would be provided medication and some basic information about living with the disease, as well as, perhaps, some additional guidance about coping with chronic stress and pain. We believe that our comparison condition goes beyond this to provide a bona fide intervention in itself.