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Arthritis, Juvenile clinical trials

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NCT ID: NCT02277444 Active, not recruiting - Arthritis, Juvenile Clinical Trials

A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy

GO-VIVA
Start date: December 17, 2014
Phase: Phase 3
Study type: Interventional

The 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.

NCT ID: NCT02218892 Active, not recruiting - Clinical trials for Juvenile Idiopathic Arthritis

Prediction of Temporomandibular Involvement in Juvenile Idiopathic Arthritis

Start date: February 2011
Phase:
Study type: Observational

Purpose and aims The general aim of this project is to improve the diagnostic methods for disease activity and identify predictive factors (clinical and radiographic factors, pro- and anti-inflammatory mediators in saliva and plasma) for temporomandibular joint (TMJ) involvement in juvenile idiopathic arthritis (JIA). The hypothesis is that self-reported pain and impaired jaw function together with clinical findings correlates well with radiological signs of jaw involvement. Null hypothesis: Self-reported pain, impaired jaw function and clinical findings do not correlate with radiological signs of jaw involvement. Study 1 The aim of this study is to investigate which findings from the patient history and from clinical examination that is of significance for diagnostics of TMJ involvement in patients with JIA both in a short- and long-term perspective. The patients will be followed-up during two years. They will undergo a clinical examination according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD; Dworkin and LeResche 1992) once a year and a telephone follow-up sixth months after the clinical examination. Further, the clinical findings from the orofacial regions will be compared to their general disease activity. Study 2 The aim of the second study is to correlate radiological findings and clinical findings in order to investigate any early radiological signs of disease activity and progression but also to compare the radiographic examination using conventional panoramic technique with computer tomography (CT).

NCT ID: NCT02116504 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Anti-Biopharmaceutical Immunization: Prediction and Analysis of Clinical Relevance to Minimize the Risk of Immunization in Rheumatoid Arthritis Patients or Juvenile Idiopathic Arthritis Patients

ABI-RA
Start date: April 2014
Phase: N/A
Study type: Interventional

One of the main potential causes of these failures of BP therapy response is the development of Anti-drug Anti-body (ADAb) in some patients. ADAb may decrease the efficacy of BPs by neutralizing them or modifying their clearance and they may be associated with BP-specific hypersensitivity reactions. The prediction, prevention and cure of anti-drug (AD) immunization are thus major goals in BP development. This prospective study (ABI-RA) will assess the occurrence of ADAb using standardized and validated assay(s) and also cellular, genetic and molecular parameters in RA/JIA patients treated with adalimumab, etanercept, infliximab and rituximab or tocilizumab, to address the mechanism of immunogenicity. Patient-related factors that might predispose an individual to an immune response will be taken into account: underlying disease, genetic background, immune status, including immunomodulating therapy and dosing schedule.

NCT ID: NCT01500551 Active, not recruiting - Clinical trials for Juvenile Idiopathic Arthritis

Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

Start date: March 18, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.

NCT ID: NCT01151644 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases

Start date: April 2010
Phase: Phase 4
Study type: Interventional

The prognosis of rheumatic diseases has improved considerably with development of therapy. However, infections are considered the most important cause of morbidity and mortality in this group of patients. One of the ways to prevent such complications is vaccination. In 2009, a new pandemic strain of influenza virus (A/H1N1/2009) has emerged raising major concerns for public health. Patients under immunosuppressive therapy have indication for immunization against influenza virus H1N1. There are, however, concerns about possibility of reactivation of autoimmune diseases, determine adverse events and insufficient immunogenicity in these patients. The lack of studies evaluating the efficacy and safety of the vaccine against influenza A(H1N1)/2009 in these rheumatic patients led to the development of this research. The objectives of this study are to evaluate the humoral response and safety of the vaccine virus A(H1N1)/2009 in immunosuppressed patients with rheumatic diseases compared to healthy controls. We have recruited 400 patients with rheumatoid arthritis, 350 with spondyloarthritis, 1000 with systemic lupus erythematosus (SLE), 150 with dermatomyositis (DM), 100 with mixed connective tissue disease, 150 with systemic vasculitis, 250 with systemic sclerosis (SSc) , 100 with Sjögren's syndrome, 100 with antiphospholipid syndrome, 100 patients with juvenile idiopathic arthritis, 80 with juvenile SLE, and 80 with juvenile DM, followed at our Rheumatology Outpatient Division and Unit Pediatric Rheumatology Children's Institute, HC-FMUSP. The control group was recruited were 200 healthy employees of ICHC-FMUSP. Informed consent was obtained from all participants and the study was approved by the Local Ethical Committee. All subjects were vaccinated against influenza virus A/(H1N1)/2009 (vaccine approved and supplied by Instituto Butantan-São Paulo). Blood samples was collected to measure levels of antibodies inhibiting hemagglutination by influenza virus A (H1N1)/2009 immediately prior to vaccination and 21 to 28 days after vaccination., Participants fulfilled a questionnaire on the immediate side effects of the vaccine. All patients with rheumatoid arthritis, spondyloarthritis, SLE, DM, systemic vasculitis, juvenile idiopathic arthritis, juvenile SLE, and DM were assessed before and 21 days after vaccination for clinical, laboratory parameters of disease activity as well as treatment. Continuous variables will be compared by t-test to evaluate differences between patients with rheumatic diseases versus healthy controls. Differences between categorical variables will be evaluated using the chi-square or Fisher exact test. Statistical significance was set at p<0.05.

NCT ID: NCT00006055 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases

Start date: March 2000
Phase: N/A
Study type: Interventional

OBJECTIVES: I. Determine whether there is prompt engraftment after autologous peripheral blood stem cell transplantation using filgrastim (G-CSF) mobilization in patients with life threatening autoimmune diseases. II. Determine the kinetics of T- and B-cell immune reconstitution after a combination of timed plasmapheresis, high dose cyclophosphamide and total lymphoid irradiation, and posttransplant immunosuppression with cyclosporine in these patients. III. Determine whether this treatment regimen beneficially influences the clinical course of these patients.