Effects of Treatment of Chronic Stress in Patients With Lupus
Systemic Lupus ErythematosusDaily stress can worsens the clinical course of lupus. Objective: to determine the efficacy of the stress management therapy in a group of patients with lupus. 45 patients with lupus and high daily stress participated in this clinical trial. Two groups resulted: a control group (CG) that received the usual care and a therapy group (TG) that received a cognitive behavioral therapy. The therapy consisted of ten consecutive weekly sessions. The measured variables were psychological, clinical, immunological and quality of life. At the basal moment and after 3, 9 and 15 months. Statistical analysis showed a significant reduction in the levels of depression, anxiety and daily stress in the therapy group, compared to the usual care group, a significant improvement in quality of life, improvements in the reported symptoms (cardiovascular, respiratory, cutaneous and musculoskeletal.
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus...
Systemic Lupus ErythematosusRheumatoid ArthritisThis is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This study will include two parts: Part A and Part B. Part A will consist of single ascending dose cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of approximately 112 subjects at approximately 10 sites.
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination...
Systemic Lupus ErythematosusLupus Erythematosus1 moreThe purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active SLE who are receiving stable background therapy for SLE.
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants...
VasculitisSystemic Lupus Erythematosus (SLE)The primary objective of this study will be to evaluate the safety and tolerability of single and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female participants.
OPAM-IA: Using Digital Activity Trackers to Improve Physical Activity in Inflammatory Arthritis...
Joint DiseasesRheumatoid Arthritis1 moreBeing physically active can reduce pain and fatigue, improve mobility and enhance quality of life in people with arthritis, but adherence to an active lifestyle is poor, with less than half of people with arthritis being active. The primary goal of this randomized controlled trial is to assess the efficacy of a physical activity coaching model to improve physical activity participation and reduce sedentary time in patients with Rheumatoid Arthritis and Systemic Lupus Erythematosus. This model combines the use of a Fitbit Flex (wireless physical activity tracker) paired with a FitViz application, a group education session, and telephone counselling by a physiotherapist.
A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
Systemic Lupus ErythematosusThe purpose of this study is to compare the genotype-based personal prescription of cyclophosphamide with the traditional prescription.
Development and Evaluation of Modified Yoga in Systemic Lupus Erythematosus (SLE)
Systemic Lupus ErythematosusThe purpose of this study is to test the effects of a modified yoga program in persons with SLE.
Exploratory Study of Changes in Disease Activity and Biomarkers With ABR-215757 in Patients With...
Systemic Lupus ErythematosusThis is an exploratory open label single arm study to evaluate changes in disease activity and biomarkers in patients with mild active SLE, during treatment with ABR-215757 given as add-on to standard therapy. To be eligible for the study SLE patients should present with symptoms from skin, mouth and/or joints. After a screening period of one week patients will be treated with ABR-215757 for 12 weeks. The initial dose of ABR-215757 will be 1.5 mg/day. There will be an option to increase the dose to 3.0 mg/day following 28 days of treatment. Follow-up visits will take place 4 weeks and 8 weeks after last day of treatment. Disease activity during treatment will be studied using the Systemic Lupus Erythematosus disease Activity Index (SLEDAI-2K) as well as organ system specific disease activity indexes (CLASI for skin involvement and number of swollen/tender joints using 28- and 66/68-joint counts). At specified time points during the study, blood samples and biopsies will be collected for analysis of established and exploratory biomarkers of SLE. Concomitant SLE treatment allowed include: prednisolone or equivalent at a dose of ≤15 mg/day, hydroxychloroquine, azathioprine, methotrexate and mycophenolate mofetil, all at stable doses from specified timepoints prior to the study and throughout the study.
Aspirin Resistance in Systemic Lupus Erythematosus (SLE)
Systemic Lupus ErythematosusThis study examine whether patients with lupus respond to aspirin , and if not, if that is related to inflammation. We examine the ability of aspirin to inhibit the production of thromboxane in patients with lupus and controls and see if aspirin insensitive thromboxane production is inhibited by meloxicam.
Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus
Systemic Lupus ErythematosusThe study will compare the efficacy of the usual education materials to individualized computerized decision guide on decision conflict of patients with lupus nephritis making treatment decisions regarding immunosuppressive therapies.