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54 active trials for Autoimmune Diseases

Chronic Inflammatory Disease, Lifestyle and Treatment Response

Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis are treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-? (TNF), i.e. TNF inhibitors. Up to one third of the patients do, however, not respond to biologics and lifestyle is assumed to affect the treatment outcome. However, little is known on the effects of lifestyle as a prognostic factor (possibly enabling personalised medicine). The aims of this multidisciplinary collaboration are to identify lifestyle factors that support individualised forecasting of optimised treatment outcome on these costly drugs. This prospective cohort study will enrol CID patients assigned for biologic treatment. At baseline (Pre-treatment), patient characteristics are assessed using patient-reported outcome measures and clinical assessments on disease activity, quality of life, and lifestyle together with registry data on comorbidity and medication. Follow-up will be conducted at week 14-16 after treatment initiation (according to the current Danish standards). Evaluation of a successful treatment outcome response will - for each disease - be based on most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients with specific lifestyle characteristics. The overarching goal of this project is to improve the lives of patients suffering from CID, by providing evidence to support dietary recommendations likely to improve the clinical outcome. The study is approved by the local Ethics Committee (S-20160124) and the local Data Agency (2008-58-035). The study findings will be disseminated in peer-reviewed journals, via patient associations, and presented at national and international conferences.

Start: September 2017

Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorbers GLOBAFFIN® and LIGASORB® and IgE Immunoadsorber IgEnio® in Clinical Routine (SEPIAR)

Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorbers GLOBAFFIN®, LIGASORB® and IgEnio® in clinical routine according to their intended use.

Start: September 2019

Collection and Distribution of Biospecimens for Novel Research Uses

iSpecimen aims to create a clinical partner network of hospitals, laboratories, academic institutions, and other healthcare organizations ("institutions") capable of providing researchers and educators ("researchers") with annotated biospecimens for use in biomarker discovery and validation; diagnostic test and instrumentation development and validation; therapeutics development; other medical research including the impact that various specimen collection and handling methods and conditions have on research results; and in education such as researcher or physician training (collectively "research").

Start: June 2016

Cognitive Changes After Major Joint Replacement - Full Trial (Cognigram 2)

Patients assume that cognitive performance rapidly returns to baseline after anesthesia and surgery. Several studies have shown that one week after major non-cardiac surgery about 27% of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months. Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly reduces quality of life. Identifying risk factors for POCD is important because it is associated with prolonged hospital stay, loss of independence, and premature retirement. There is an urgent need to measure and document the level of cognitive change associated with surgery with an easy to use tool, both prior to admission and after discharge. This information can be used to plan appropriate care paths and to identify or test the efficacy of potential new treatments to alter the negative trajectory.

Start: May 2017

Diabetes Islet Preservation Immune Treatment

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

Start: December 2021

Covid-19 in Patients With Chronic Inflammatory Rheumatism, Auto-immune or Auto-inflammatory Rare and Non-rare Diseases

Since December 2019, an international outbreak of respiratory illnesses caused by SARS-CoV-2 called covid-19 has become a global challenge. In France, while the first cases were reported in January, more than 20 000 cases were confirmed at end of March. Early estimations from epidemiological data seem to show that 18-20% of patients with confirmed covid-19 are admitted in an intensive care unit (ICU). Patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases are susceptible to severe covid-19 (i.e ICU) due to the specific therapeutic management of their illness (corticosteroid, immunosuppressive and immunomodulatory drugs,..). No data are available for this particular population in France. This retrospective multicentre observational study aims to evaluate the frequency of severe forms of covid-19 and risk factors associated with specific outcomes in covid-19 in patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases.

Start: April 2020

Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

This protocol seeks to assist biorepositories/biobanks in distributing their stored specimens and data to researchers that will actually utilize them to advance medicine and technology.

Start: December 2020

"Circulating Fetal DNA, Pregnancy And Immune Diseases"

In the plasma of any pregnant patient circulates DNA (also called circulating free DNA). The vast majority of this circulating free DNA is of maternal origin and about 10% is of fetal origin (fetal circulating free DNA). This percentage of fetal circulating free DNA (corresponding to the fetal fraction) increases with gestation. The pathophysiological hypothesis of this research is that there is a change in the fetal fraction (FF) of fetal circulating free DNA in patients with autoimmune disease (AID). The underlying mechanism would be a massive release of maternal cfDNA responsible for a dilution of fetal cfDNA. This dilution of fetal cfDNA would result in a decrease in the estimate of the foetal fraction of circulating free DNA. However, when the foetal fraction of circulating free DNA is insufficient (4% most often), screening for Trisomy 21 (T21) by fetal circulating free DNA becomes uninterpretable (NC for "non-contributory" result), and cannot be used to assess the risk of T21. In this case, the dose of fetal circulating free DNA can be performed again after 15 days, as the amount of fetal circulating free DNA increases with gestation. In a small number of cases the result will remain NC. As tests using DNA are becoming more widespread, it is important to prospectively evaluate the results of these tests in the population of patients with AID, which represents about 3 to 5% of pregnant women.

Start: December 2019

Withdraw Drug in Stable IgG4-Related Disease

Evaluation and prediction of relapse risk after glucocorticoid or immunosuppressant withdrawal in patients with stable IgG4 related disease: a prospective cohort study from china.

Start: October 2019

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Health Subject

SN1011 (the study drug), is currently being developed by Sinomab as a new drug for treating autoimmune disease (diseases occurring when your body's natural immune/defence mechanism attacks healthy tissue and nerves), such as rheumatoid arthritis (RA). RA causes recurrent joint pain and swelling, particularly in the hands and feet, and can lead to bone erosion and joint deformity. SN1011 is known as a BTK inhibitor. Bruton's tyrosine kinase (BTK) is an enzyme that plays a key role in B-cell development, and B-cells play an important role in immunity throughout the body. It is thought that blocking the BTK signal may inhibit disease progression in people with RA and may even resolve the disease. The purpose of this research study is to assess the safety and tolerability of SN1011 as well as the pharmacokinetics (PK - how your body handles the study drug) and pharmacodynamics (PD - how the study drug affects your body) of the study drug. The investigators are doing this study in healthy men and women.

Start: August 2019

EBMT ADWP Prospective Non-interventional Study: Post-AHSCT Management in SSC Patients (NISSC-2)

The aim of the study is to assess the effectiveness of various post-transplant treatment management approaches on clinical and immune biological responses after Autologous Hematopoietic Stem Cell transplantation (AHSCT) for Systemic Sclerosis (SSc) as currently performed by the different treatment protocols used in routine clinical practice across Europe in various EBMT centres

Start: July 2019

Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions

To determine the safety and efficacy of Amniotic and Umbilical Cord Tissue for the treatment of the following condition categories: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The hypotheses are that the treatments are not only extremely safe, but also statistically beneficial for all conditions. Outcomes will be determined by numerous valid outcome instruments that compile general quality of life information along with condition-specific information as well.

Start: September 2019

Clinical Characteristics of Interstitial Pneumonia With Autoimmune Features (IPAF) - a Multicenter Prospective Study

Interstitial pneumonia with autoimmune features (IPAF) was defined in 2015 by the Working Group of the European Respiratory Society (ERS) and the American Thoracic Society (ATS) as interstitial pneumonia with some clinical and/or serological features suggesting presence of an underlying autoimmune disorder. However, ofiicial criteria for diagnosis of an autoimmune disease are not met. Aims of the study: Determine the incindence of IPAF in comparison with interstitial lung diseases (ILDs) and classic autoimmune diseases (ADs) in polish pulmonological centers. Clinical, serological, functional and radiological and histopathological characteristics of IPAF patients. Analysis of diagnostic strategies towards specific IPAF subgroups. Characterictics of potencial diagnostic, predictive and prognostic features of IPAF. Prospective assessment of IPAF patients in the courseof 5 years in order to determine stability of the diagnosis and potential progression to other diseases, e.g. ADs.

Start: March 2019

Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders

The main purpose of this study is to examine the outcome of a combined bone marrow and kidney transplant from a partially matched related (haploidentical or "haplo") donor. This is a pilot study, you are being asked to participate because you have a blood disorder and kidney disease. The aim of the combined transplant is to treat both your underlying blood disorder and kidney disease. We expect to have about 10 people participate in this study. Additionally, because the same person who is donating the kidney will also be donating the bone marrow, there may be a smaller chance of kidney rejection and less need for long-term use of anti-rejection drugs. Traditionally, very strong cancer treatment drugs (chemotherapy) and radiation are used to prepare a subject's body for bone marrow transplant. This is associated with a high risk for serious complications, even in subjects without kidney disease. This therapy can be toxic to the liver, lungs, mucous membranes, and intestines. Additionally, it is believed that standard therapy may be associated with a higher risk of a complication called graft versus host disease (GVHD) where the new donor cells attack the recipient's normal body. Recently, less intense chemotherapy and radiation regimens have been employed (these are called reduced intensity regimens) which cause less injury and GVHD to patients, and thus, have allowed older and less healthy patients to undergo bone marrow transplant. In this study, a reduced intensity regimen of chemotherapy and radiation will be used with the intent of producing fewer toxicities than standard therapy. Typical therapy following a standard kidney transplant includes multiple lifelong medications that aim to prevent the recipient's body from attacking or rejecting the donated kidney. These are called immunosuppressant drugs and they work by "quieting" the recipient's immune system to allow the donated kidney to function properly. One goal in our study is to decrease the duration you will need to be on immunosuppressant drugs following your kidney transplant as the bone marrow transplant will provide you with the donor's immune system which should not attack the donor kidney.

Start: November 2012