Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of GSK2646264 in Cutaneous...
Lupus ErythematosusCutaneousThis study is designed to examine safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effect of repeat dosing of GSK2646264 in patients with subacute and chronic cutaneous lupus erythematosus (CLE) lesions and in acute CLE like lesions induced by photoprovocation (PV). Current study is two group study. In Group A, Patients with fewer than two active lesions will be enrolled and exposed to photoprovocation (PV) for 3 consecutive days. Patients that develop PV lesions at any time during this period, as determined by the local investigative team, will receive 1% strength GSK2646264 on 1 lesion and placebo on 1 lesion daily and either 1% strength GSK2646264 or placebo on an area of uninvolved skin, for skin pharmacokinetic (PK) of study drug, for 28 days. In Group B, Patients that have a minimum of 2 active existing CLE lesions as determined by the investigators will be enrolled into group B and have one lesion treated with 1% GSK2646264 and 1 lesion with placebo. A completed patient will be defined as a subject who receives at least 25 days of study drug and completes the end of treatment biopsy (at day 28) and assessment. Thereafter patients will be followed for 28 days in Group A only or until complete resolution of induced PV lesions, as determined by the investigator.
A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic...
Systemic Lupus ErythematosusThis is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).
Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
Systemic Lupus ErythematosusThe 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, Besides ,to provide dose basis for follow-up clinical trials.
Systemic Lupus Erythematosus Exercise Program
Systemic Lupus ErythematosusThis pilot study is a randomized controlled trial to assess the effect of an individualized supervised exercise program in patients with systemic lupus erythematosus (SLE) compared to treatment-as-usual (TAU).
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
Active Systemic Lupus ErythematosusThe purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.
A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous...
Lupus ErythematosusCutaneousThe purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.
Mindfulness- Based Intervention for Systemic Lupus Erythematosus (SLE) Patients
PsychologicalSystemic lupus erythematosus (SLE) is a rheumatic autoimmune disease, involving chronic pain, fatigue, movement difficulties, and is often accompanied by tremendous psychological and psychiatric difficulties. Mindfulness-based Intervention (MBI), is a mind-body intervention, which has been documented in several studies as effective among stress- related diseases, such as crohn's disease. Nevertheless, not much is known about the efficiency of MBI among SLE patients and about the mechanisms of change through which MBI works. In the present study, the investigators are focusing on different cognitive mechanisms and their role in MBI action. The study is a randomized-controlled trial. 26 Patients diagnosed with SLE (Mean age=41.26) were randomly assigned to either a 10-weeks MBI intervention (N=15) or a waitlist-control (WL;N=11).4 central measurements points were conducted through the study, which included physiological and psychological variables: at the beginning of the intervention (T1), in the middle of the intervention (T2) at the end of the intervention (T3) and one 6 months follow- up measurement after the termination of the intervention (T4). additionally, participant's blood test has been taken at the beginning and at the end of the intervention.
Belimumab in Patients With Systemic Lupus Erythematosus
Systemic Lupus ErythematosusThe BeliLES-GEAS project pretends to obtain an extensive data registry of patients with systemic lupus erythematosus (SLE). The main objective is to create a national SLE patients registry treated with belimumab to describe effectiveness and safety of intravenous (IV) or subcutaneous (SC) belimumab in patients with active SLE treated in the Spanish departments of Internal Medicine in a real-life setting. This research project aspires to cover the vast majority (if not the whole) of SLE patients treated with belimumab in all of the Spanish Departments of Internal Medicine.
Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)
Systemic Lupus ErythematosusTo assess the pharmacokinetic parameters of anifrolumab in Chinese participants with active systemic lupus erythematosus(SLE).
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Cutaneous Lupus ErythematosusPrimary Objective: Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity) Assess the effect of SAR443122 on CLE induced itch and overall pain Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo Assess the effect of SAR443122 on the CLASI components score Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE) Assess oral cavities for patients with oral lesions Assess the disease specific quality of life (QoL) Assess the safety and tolerability of SAR443122 in patients with CLE Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE