View clinical trials related to Autoimmune Diseases.
Filter by:The overall goal of this clinical trial is to evaluate the causality relationship between the non vagus nerve stimulation waveform parameters and the therapeutic effect. Thus, unlocking a pathway to optimize parameters that maximize the benefits of therapy and minimize unwanted side effects. The experimental design includes the analysis of physiological signals, clinical biomarkers of disease, and clinical outcomes to determine the most effective measures for the monitoring, optimization, and personalization of non vagus nerve stimulation in systemic lupus erythematosus disease.
A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.
Mental fatigue occurs in many diseases and the reasons are mostly unknown. The investigators hypothesize that remaining mental fatigue after restored hyperthyroidism in Graves' disease is an autoimmune complication. The aim of this study is to explore immunological markers possibly associated with mental fatigue in Graves' disease, which the investigators plan to validate in another study (ImmunoGraves wp 2). Using a cross-sectional study design, mental fatigue is scored using a questionnaire to find 60 patients with and 60 without mental fatigue 15-60 months after diagnosis of Graves disease. The patients and 60 thyroid healthy controls without mental fatigue are assessed for thyroid hormones, quality of life, anxiety and depression, self-evaluated stress, coping strategies, eye symptoms and background variables. SciLifeLab in Stockholm, the national facility for autoimmune profiling, has pre-set large arrays including 42000 human proteins. Serum and cerebrospinal fluid will be separately pooled and analysed for a subgroup of patients with or without mental fatigue and for a subgroup of the control group. Proteins that preferably bind to antibodies in sera and/or cerebrospinal fluid from Graves' patients with mental fatigue in comparison to non-mental fatigue patients, will be screened against the Human Protein Atlas and the Allen brain map to identify those proteins that are expressed in the brain. Antibodies at higher concentration in the mental fatigue pools compared to the group without mental fatigue will be selected for further analyses on an individual level in the whole cohort together with antibodies targeting g-protein coupled receptors, thyroid autoantibodies, cytokines and biomarkers indicating organic and structural nerve damage.
The purpose of this study is to see if the study medication, daratumumab, is safe to treat individuals with Anti-Phospholipid Syndrome (APS). Three daratumumab dosing cohorts are planned with up to six participants in each dosing cohort with the potential to enroll an additional 4 subjects in the highest safe dose (HSD) cohort, for a total of up to 22 participants. The dosing cohorts are: 4 mg/kg, 8 mg/kg, and 16 mg/kg. Each cohort will receive intravenous (IV) administration of daratumumab according to the following schedule, for a total of 8 doses. The primary objective is to determine the safety of daratumumab in APS defined as Dose Limiting Toxicities (DLTs) occurring during the dose escalation phase.
A multi-centre, prospective study to study cytokine profiles and other potential disease-specific biomarkers in patients with presumed or confirmed diseases of systemic inflammation The goal of this prospective, observational study is to describe the longitudinal evolution of blood cytokine profiles in patients with presumed or confirmed diseases of systemic inflammation The main questions it aims to answer are: - What are the differences and similarities in blood cytokines between different patients and groups presenting symptoms of systemic inflammatory conditions? - How is the cytokine profile of individual patients evolving over time and what is the effect of different therapeutics? - Is cytokine profiling a valuable tool to diagnose and follow-up on patients with systemic inflammatory conditions? Participants will be asked to give an additional blood volume for research purposes when blood sampling is performed for routine clinical purposes. A subset of patients (those initiated on biologicals) will also be asked to complete questionnaires. Researchers will compare the blood cytokines profiles between the different groups of systemic inflammatory conditions and with healthy individuals.
Title: Effects of immunomodulatory therapy on gonadal function in women with autoimmune premature ovarian insufficiency (POI) Trial objectives and purpose: To study if rituximab therapy can improve ovarian response to gonadotropin stimulation and menstrual function in women with autoimmune POI. Treatment: Controlled ovarian hyperstimulation before and four months after an infusion of 1-gram rituximab (Mabthera®) twice with two weeks interval. Follow-up period 12 months after infusion. Primary outcome: Number of antral follicles and the size of the largest follicle in response to ovarian stimulation. Secondary outcomes: 1. Reestablishment of spontaneous menstrual bleedings during the 12 months' study period 2. Ovulation during the 12 months' study period 3. Change in B-cell count, autoantibody indices and immunoglobulin levels (IgG) after treatment Safety outcomes: All adverse events. Of particular relevance are any hospital admissions, infections and allergic reactions. Study population: Fifteen women with autoimmune POI defined as absence of menstruation > 6 months and elevated serum level of follicle stimulation hormone > 40 International units (IU)/L. Inclusion criteria: Autoimmune POI defined as presence of autoantibodies against 21-hydroxylase (OH), side chain cleavage enzyme (SCC), 17-OH and/or neuronal apoptosis inhibitory protein (NACHT) leucine-rich-repeat protein 5 (NALP5) or other relevant autoantibodies; 18-35 yrs of age; body mass index 19-30. Exclusion criteria: Hypersensitivity to rituximab; severe infection; severe immunosuppression; cardiac disease; cancer; benign tumours of the hypothalamus, pituitary, or ovary; ovarian enlargement or ovarian cyst; vaginal bleeding of unknown aetiology. Time plan: The study is expected to start the spring 2017. It is expected to be closed spring 2023.
This is an open-label, multicenter, Phase 1/2 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D
TRACER is a study aiming to investigate the feasibility of transition coaching sessions for patients moving from paediatric to adult rheumatology care.
The purpose of this study is to assess the feasibility, safety and efficacy of CAR-T cell therapy in patients with autoimmune disease. Another goal of the study is to learn more about the safety and function of the CAR-T cells and their persistency in autoimmune disease patients.
Determination of autoantibodies against fragments derived from neurons, glia, and myelin sheath is instrumental in aiding diagnosis, differential diagnosis, as well as determining disease status of neuromyelitis optica spectrum disorders (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), autoimmune encephalitis (AE). Cell based assay (CBA) has been frequently recommended to detect autoantibodies of neuroantigens in the aforementioned neurological disorders. However, antibodies with low abundance or low affinity often fall beyond the threshold of CBA and pose significant challenges in practice. To this end, the investigators adopted a tyramide signal amplification (TSA) technology with the basis of CBA to improve sensitivity. The preliminary results suggest that this TSA-CBA platform is superior to conventional CBA in registered signals of the titer autoantibodies. In elevating the sensitivity, TSA-CBA also preserves antigen confirmation. This prospective study is launched to compare the sensitivity, specificity, clinical correlation between CBA and CBA-TSA, in determining autoantibodies against aquaporin 4 (AQP4-IgG), myelin oligodendrocyte glycoprotein (MOG-IgG), N-methyl-D-aspartate receptor (NMDAR-IgG) in a multicenter, double-blind setting.