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Arthritis, Juvenile clinical trials

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NCT ID: NCT05083182 Recruiting - Arthritis, Juvenile Clinical Trials

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

PSUMMIT-Jr
Start date: August 30, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).

NCT ID: NCT05055882 Recruiting - Still Disease Clinical Trials

Auvergne-Rhône-Alpes-Limousin Research Database for Still's Diseases in Children and Adults

AURAL-STILL
Start date: February 1, 2020
Phase:
Study type: Observational

Adult-Onset Still's disease is a polygenic autoinflammatory disease of unknown etiology. The autoinflammatory character individualizes it from autoimmune autoantibody diseases. Clinically, it results in the classic triad associating hectic fever, evanescent rash and arthritis. Although it is benign in the vast majority of cases, life-threatening complications can occur. By definition, the disease affects adults over 16 years of age, however most experts now agree that the adult form and the pediatric form belong to a pathological continuum: Still's disease. In the absence of a specific biomarker, the diagnosis is still based on clinical and biological criteria, after the exclusion of differential diagnoses. Classically, three evolutionary profiles of Adult-Onset Still's disease are individualized, depending on the evolution of symptoms over time: - a monocyclic systemic form (30% of cases) characterized by clear systemic symptoms and in the foreground compared to the articular signs. This form evolves over several weeks to several months (on average 9 months), without exceeding a year. By definition, there is no recurrence; - a polycyclic systemic form (30% of cases) defined by the occurrence of at least two systemic or joint episodes, separated by clinical remission intervals greater than two months, or even several years. The symptoms of relapses are not always the same as the initial symptoms. The number and severity of relapses is unpredictable and varies widely from patient to patient, but symptoms tend to become less severe over time. - a chronic form, with predominant joint involvement (40%), resembling seronegative rheumatoid arthritis. Systemic signs are present during the first outbreaks of the disease. Subsequently, rheumatoid arthritis evolves on its own and one can see joint destruction or conversely ankylosing developments such as the classic bilateral, non-erosive fusing carpitis. There are reasons to believe that the evolving profile of patients has changed since the emergence and generalization of biotherapies. Furthermore, no prognostic factor for the progression of Adult-Onset Still's disease has been found so far. The differences between pediatric and adult forms need to be confirmed and becoming pediatric forms in adulthood is poorly described. The objective of this study is to set up a regional research database (Auvergne-Rhône-Alpes-Limousin) in order to describe the characteristics, treatment and evolution of patients with Still's disease.

NCT ID: NCT05045001 Recruiting - Clinical trials for Rheumatoid Arthritis

Pharmacogenetic Studies on Anti-IL-6 Receptor Monoclonal Antibodies on the Treatment of Rheumatic Diseases

Start date: June 2, 2021
Phase:
Study type: Observational

Tocilizumab and Sarilumab are first-line biological disease-modifying anti-rheumatic drug (bDMARD) which inhibits Interleukin 6 (IL-6) pathway through blockade of its receptor on the treatment of Rheumatoid Arthritis and other rheumatic diseases as Giant Cell Arteritis, Still's disease and Idiopathic Juvenile Arthritis. At present, there is a lack of evidence to recommend the treatment of one bDMARD over another. Seeking for genetic biomarkers to predict response to treatment could be key towards a personalized treatment strategy in rheumatology. The investigators aime to evaluate whether functional single nucleotide polymorphisms (SNPs) in the IL6R gene could predict response and/or toxicity in patients with rheumatic diseases treated with anti-IL-6 receptor drugs.

NCT ID: NCT05031104 Completed - Fatigue Clinical Trials

Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis

Start date: October 21, 2018
Phase: N/A
Study type: Interventional

This study endeavored to evaluate the auxiliary effect of low-energy laser therapy (LLT) on pain, muscle performance, fatigue, and functional ability in children with juvenile idiopathic arthritis (JIA). Sixty patients with JIA were randomly allocated to the LLT group (n = 30, received LLT in addition to the standard exercise program) or the control group (n = 30, received standard exercise program only). Both groups were assessed for pain intensity, muscle performance, fatigue perception, and functional status.

NCT ID: NCT05027373 Recruiting - Clinical trials for Systemic Juvenile Idiopathic Arthritis

Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection

Start date: August 13, 2021
Phase: Phase 1
Study type: Interventional

This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody injection in Healthy Subjects. Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.

NCT ID: NCT05000216 Completed - Clinical trials for Rheumatoid Arthritis (RA)

COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

Start date: August 13, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine. The study will focus on 5 autoimmune diseases in adults: - Systemic Lupus Erythematosus (SLE) - Rheumatoid Arthritis (RA) - Multiple Sclerosis (MS) - Systemic Sclerosis (SSc), and - Pemphigus. This study will focus on 4 autoimmune diseases in pediatric participants: - Systemic Lupus Erythematosus (SLE) - Juvenile Idiopathic Arthritis (JIA) - Pediatric-Onset Multiple Sclerosis (POMS) - Juvenile Dermatomyositis (JDM)

NCT ID: NCT04903067 Recruiting - Clinical trials for Juvenile Idiopathic Arthritis

An Investigation Into the Relationship Between Dietary Intake and Health-related Quality of Life in Children and Young People With Juvenile Idiopathic Arthritis

JIA
Start date: May 1, 2021
Phase:
Study type: Observational

"Physical activity and diet in children and young people with arthritis" A qualitative study of exploring stake holder's experiences. Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis in children under the age of 16. The disease and its therapeutic management can cause serious long-term complications, which affect general activities and quality of life. The lack of specific guidelines for safe physical activity and appropriate management of any nutritional deficit aiming our study to find out your views and opinions about the needs of children and young people with juvenile idiopathic arthritis. We want to improve our knowledge about the impact of physical activity and eating habit on juvenile idiopathic arthritis and we want to develop a tool to help evaluate care. Few studies targeting quality of life and wellbeing in children adolescent populations have adopted the diet and physical activity perspective or approaches, consequently, this research project will help to address this gap through: 1. Interview: to look at young people's current experiences with JIA as well as their parents/caregivers and health care professionals. Study findings will provide a snapshot of the current experiences of participants, helping to improve our knowledge about JIA, physical activity, and diet. Qualitative studies exploring people perspectives on their experiences, when collected systematically, adds valuable depth, insight and understanding into the issues related to JIA not possible through quantitative methodologies. This study uses a qualitative approach known as framework methodology to understand stakeholder's experience of what helps and what hinders improving the quality of life in children and young adult with JIA. 21-30 stakeholders will be recruited in Oxford UK, to take part in individual semi-structured guided interviews lasting approximately one hour. Participant responses will be transcribed by the chief investigator and analysed to extract themes that will answer the research question. 2. Delphi study: which aims to develop a diet and physical activity intervention for children and young adult with JIA.

NCT ID: NCT04902807 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation

ATRACTion
Start date: June 2021
Phase:
Study type: Observational

The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity/inflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomics, epigenomics, proteomics, metagenomics, metabolomics and lipidomics).

NCT ID: NCT04833465 Recruiting - Fibromyalgia Clinical Trials

Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

Start date: July 16, 2021
Phase:
Study type: Observational

The overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. This would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. Such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. This is a single site observational study that aims to collect initial pilot data in three distinct patient groups. As this is observational, there is no randomization or blinding in the study. Patients will be followed for a period of one year after enrollment. Baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. As this is an observational study, there will be no change to the treatment for any patient due to research activities. The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect.

NCT ID: NCT04804553 Recruiting - Clinical trials for Active Juvenile Psoriatic Arthritis

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

PEAPOD
Start date: March 17, 2022
Phase: Phase 3
Study type: Interventional

The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.