Active clinical trials for "Rheumatic Diseases"

Phase-IV, national, multicentric, non-randomized, observational real-life study. The goal of this stud is to investigate the patient's benefits in terms of quality of life and work ability resulting from the switch from infliximab i.v. to s.c. in patients with gastroenterological or rheumatological indication at month 12.Patients who are eligible but were switched before the inclusion in this study will also be enrolled, and the data already collected according to clinical practice and consistent with the study outcome measures will be used retrospectively. All patients will be followed up according to the standard of care of each participating center. The main questions it aims to answer are: To investigate the effectiveness at month 2, 6 and 12 after switching to infliximab s.c. To investigate the safety profile at month 2, 6 and 12 after switching to infliximab s.c. To investigate the difference between patients with rheumatological diseases and patients with IBD in terms of quality of life and work, effectiveness and safety at month 2, 6 and 12 after switching. To investigate the presence of baseline predictors for drug persistence at month 12 (sex, age, disease type, disease severity, body mass index, concomitant medications, smoking habit, presence of comorbidities). To investigate whether there is any change between baseline and week 52 in the following aspects: Job type and need for any authorization to go to the hospital to receive the study drug Distance and duration of the travel home-hospital Mode of travel home-hospital Need for a caregiver to be present Time spent at hospital Patient's preference for the way of study drug administration expressed on a 10-grades VAS scale. The study period for observation will be 12 months from the date of switch. At week 0, month 2, 6 and 12 from the date of the switch, clinical activity, safety data and biomarker levels will be collected. For those patients who have had an endoscopic evaluation of the disease within 2 months of inclusion and repeat the endoscopic evaluation at 12 months ± 8 weeks, endoscopic data will also be collected (valid only in the presence of IBD). In those centers where a blood sample to analyze the minimum levels and anti-drug antibodies of infliximab has been collected and/or stored within 2 months prior to the date of transition, the patient will be asked to give informed consent to the use of this sample and to provide a blood sample for the same analysis at week 0, month 2 and 12. These samples will be analyzed and compared to evaluate the immunogenicity of the drug. These analyzes will be centralized in one lab.

Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis

Introduction: The medical treatment of inflammatory rheumatic diseases has improved dramatically during the last decades primarily due to the introduction of biological disease modifying anti-rheumatic drugs (bDMARDs). However, bDMARD treatment failure occurs in 30-40% of patients due to lack of effectiveness or side effects. The tools to predict treatment outcomes in the individual patient are currently limited. The objective of the present study is to identify diagnostic, prognostic and predictive biomarkers, which can be used to 1) diagnose inflammatory rheumatic diseases early in the disease course with high specificity and sensitivity, 2) improve prognostication or 3) predict treatment effectiveness and tolerability for the individual patient. Methods and analysis: Observational and translational open cohort study with prospective collection of clinical data and biological materials in patients with inflammatory rheumatic diseases treated in routine care. Patients contribute one cross-sectional blood sample (i.e. whole blood, serum, EDTA-plasma and -buffy coat, and blood in PAXgene RNA tubes) and/or are enrolled for longitudinal follow-up upon start of new DMARD (blood sampling after 0/3/6/12/24/36/48/60 months' treatment). Demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected repeatedly during follow-up. Currently (June 2017) >5,000 samples from ≈3,000 patients have been collected. Data will be analysed using appropriate statistical analyses. Ethics and dissemination: The protocol is approved by the Danish Ethics Committee and The Danish Data Protection Agency. All participants give written informed consent. Biomarkers will be evaluated and published according to REMARK, STROBE and STARD guidelines. Results will be published in peer-reviewed medical journals and presented at international conferences.

The goal of this observational study has the purpose of collecting biological samples from obese patients undergoing evaluation for weight loss by means of medical or endoscopic therapies; and of post bariatric surgery patients presenting with short- and long-term surgical complications. The aim is to enhance the overall understanding of the mechanisms leading to obesity, weight loss, failure to lose weight, and weight regain following treatment. Additional goals are to determine the efficacy of endoscopic and surgical procedures, to identify potential therapeutic targets and disease biomarkers that predict response to therapy.

A joint is considered "hypermobile" when it has a greater range of motion than normal for a given age, ethnicity or gender. Many people have asymptomatic hyperlaxity in multiple joints, a condition called Generalized Joint Hypermobility (GJH). Conversely, hyperlaxity can be symptomatic, a condition that has been defined "Joint Hypermobility Syndrome" - JHS. Diagnosis of JHS is commonly performed by applying the revised Brighton criteria. Based on these criteria, an individual is diagnosed with JHS with a Beighton score >/= 4/9, and arthralgia for 3 or more months in 4 or more joints (major criteria). The dynamic body balance test (i.e. the stability test with multiple single-leg jumps) can provide information regarding the effectiveness of the feedforward and feedback mechanisms in correcting the postural deviations necessary to achieve successful performance during daily and sporting activities. Such assessment may also be useful to demonstrate deficiencies in balance, especially in young patients with increased physical activity. The aim of this study is to examine the postural balance of individuals with JHS by performing stability tests in monopodalic and bipodalic stance with the "Delos Postural Proprioceptive System"

Autoimmune diseases are the consequence of an abnormality of the immune system, leading it to attack components of our own body. They have a wide variety of presentations. They preferentially affect women, and often at a young age. Systemic lupus erythematosus, for example, most often occurs between the ages of 15 and 40. Inflammatory rheumatism, such as spondyloarthritis or rheumatoid arthritis, is less prevalent in women, but also affects young people, and is particularly common. Several disease-modifying treatments exist, depending on the severity and evolutivitý of the disease. Some are contraindicated or not recommended during pregnancy and therefore require supervision of pregnancy plans. In addition, some treatments have an immunosuppressive activitý, which implies an annual screening of cervical lesions by cervico-uterine smear. In this context, an adapted gynecological follow-up seems indispensable. The rheumatologist and the internist physician have a crucial role in advising and referring patients to their gynecological colleagues. Studying the qualitý of this gynecological follow-up in a cohort of patients with autoimmune disease or inflammatory rheumatism is of major interest.

The purpose of this study is to understand variation in the symptoms of psoriasis and psoriatic arthritis using simple, scalable smartphone-based measurements. This study uses an iPhone app to record these symptoms through questionnaires and sensors.

The primary objective of the STAR study is to investigate how measures of disease activity and measures for cognition, physical activity and performance behave in ageing population controls and patients with rheumatoid arthritis (RA). If an differential effect of age on outcome over time is apparent, the presence of an inclination point will be assessed. The secondary objective is to investigate additional factors (e.g. lifestyle factors) that might explain any differences between ageing controls and RA patients. The STAR study is an observational cross-sectional matched case-control study including 420 RA patients and 420 population controls between 55-85 years of age, stratified by five year intervals. All participants will complete generic and RA-specific questionnaires. A subset of 180 participants will be visiting the research center for physical examination and performance tests. Expected outcomes include practical age-specific reference curves that will be constructed for a selection of outcomes (e.g. DAS28). It is expected that as RA is characterized by tender and painful joints, e.g. the number of tender joints has a higher starting point in RA patients than in the general population. This will most likely increase in both groups with age, although the general population may catch up at an older age. Measures of cognitive status may show a steeper decline with age in RA patients compared to the general population. Measures of physical activity and performance will presumably have a worse starting point in RA patients than in the general population, and might show a steep decline with age. The general population might however catch up with the patients with RA. Most probably, age will not be the only factor explaining 'worse' outcomes in both RA patients and the general population. Other factors such as lifestyle factors (e.g. smoking, diet, BMI, occupation) and comorbidities will probably play a role.

Glucocorticoids remain to be among the most important and most frequently used anti-inflammatory and immunosuppressive or immune-modulatory acting drugs to treat rheumatic (and other) diseases. Unfortunately, glucocorticoids also exert undesired effects, especially if higher dosages have to be given over longer periods of time. The available data describing frequency and severity of these adverse effects are fragmentary. This statement is especially true for glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases or (in part) psoriasis(arthritis). The state of knowledge and scientific data, being sparse, is partly conflicting and often derived from over-aged projects or studies. Therefore, there are urgent needs to work on various current questions systematically and at the highest scientific level possible. In order to address these needs, we aim at collecting and analyzing disease- and bone-related data from patients with chronic inflammatory rheumatic diseases or psoriasis and therapy with glucocorticoids, and to build a respective GIOP-Databank. Patients will attend for diagnostics, and where necessary therapy and follow-up of GIOP, according to current guidelines. Clinical, laboratory and instrumental examination results from more than 1000 patients in the first three years of the project are planned to be documented in a prospective database.

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.