An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With...
Juvenile Idiopathic ArthritisPrimary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate treatment of this population Secondary Objective: To describe the pharmacodynamic (PD) profile, the efficacy and the long-term safety of sarilumab in patients with pcJIA.
A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric...
ArthritisJuvenileThe purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an onset before age 16) idiopathic (of unknown cause) arthritis (joint pain) (pJIA) manifested by greater than or equal to (>=) 5 joints with active arthritis despite methotrexate (MTX) therapy for >= 2 months.
An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA)...
Juvenile Psoriatic ArthritisEnthesitis Related ArthritisOptional open label, roll over extension study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA).
Pediatric Arthritis Study of Certolizumab Pegol
Polyarticular-course Juvenile Idiopathic Arthritis (JIA)A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA).
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the...
Juvenile Psoriatic ArthritisPsoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms. Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide. Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study of Methotrexate Given to Juvenile Idiopathic Arthritis Patients Based on Pharmacogenomics...
Juvenile Idiopathic ArthritisThis study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics model to provide reference for individual administration on JIA pediatric patients.
CAPRI National Juvenile Idiopathic Arthritis Registry
Juvenile Idiopathic Arthritis (JIA)Juvenile Idiopathic Arthritis (JIA) is a disorder of unknown cause characterized by chronic inflammation of the joints and other organs. It affects about 1 in a 1000 Canadian children and if untreated it can produce lifelong disability. The Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) includes most pediatric rheumatologists in Canada. They have successfully collaborated for the past 20 years producing groundbreaking research on the modern course and outcomes of JIA. The CAPRI JIA Registry is an ongoing universal registry of Canadian children with JIA that collects longitudinal data on disease course, outcomes and adverse events to inform healthcare decisions and to gain new insights into the disease and its treatment.
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
Rheumatoid Arthritis (RA)Systemic Lupus Erythematosus (SLE)7 moreThis 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)
AR-Power Patient Powered Research Network
Rheumatoid ArthritisAnkylosing Spondylitis11 moreArthritisPower is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), and other musculoskeletal conditions. Participants will provide information from their smartphones or personal computers. The information will be used by researchers to help patients and their providers make better, more informed decisions about treatment of RA/SpA and other musculoskeletal conditions. ArthritisPower is part of a larger national research network called PCORnet whose 33 network members have mapped their data to a common data model. Network members will be able to submit queries through PCORnet in order to answer a range of comparative effectiveness research questions. Data sharing across PCORnet will be accomplished using secure methods to prevent patient identification. There is no cost to participants for participating and no compensation is provided. Objectives: To establish a research registry to enable comparative effectiveness research in rheumatic diseases and other musculoskeletal conditions. All data collected using the ArthritisPower mobile app as part of a subject's use is stored with the ArthritisPower registry. This data will be used in conjunction with existing and future research studies. To use the data from this study to improve treatment and to further advance finding a cure for rheumatic diseases.
An Observational Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in...
Polyarticular Juvenile Idiopathic ArthritisJuvenile idiopathic arthritis (JIA) is the most common rheumatic disease affecting children, characterized by chronic synovitis with systemic multi-organ damage. Polyarticular juvenile idiopathic arthritis (pJIA) is a subtype of JIA defined as disease involving more than five joints in the first 6 months of disease. This study will assess how safe and effective adalimumab (Humira®) is in treating pediatric participants with pJIA in China real-world setting. Adalimumab is an approved drug for the treatment of pJIA. Approximately 50 participants age 2 to 17 who are prescribed adalimumab for the treatment of pJIA in routine clinical practice will be enrolled at multiple sites in China. Participants will receive adalimumab per their physician's usual prescription. Individual data will be collected for 52 weeks. No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.