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Juvenile Idiopathic Arthritis clinical trials

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NCT ID: NCT01434082 Recruiting - Clinical trials for Juvenile Idiopathic Arthritis

Sleep Patterns in Children With and Without Juvenile Idiopathic Arthritis

JIA
Start date: September 2011
Phase: N/A
Study type: Observational

The investigators are doing this study to look at sleep problems, daytime sleepiness, and thinking and behavior patterns in children with arthritis and in children without arthritis. Arthritis is a problem with joints. Some children have arthritis and some children do not have arthritis. Sleep disordered breathing is a sleeping problem in which some children snore and have pauses in their breathing during sleep. It is associated with not enough or fragmented sleep, poor school performance, problems paying attention, and behavior problems. The investigators do not know how many children with arthritis have sleep problems, and how it is linked to daytime sleepiness and children's learning, and behavior patterns compared to children without arthritis. The investigators need to study both children with arthritis and children without arthritis to learn more about these connections and to understand if they are the same or different in children with arthritis and in children without arthritis.

NCT ID: NCT01399281 Recruiting - Clinical trials for Juvenile Idiopathic Arthritis

Pharmacovigilance in Juvenile Idiopathic Arthritis Patients Treated With Biologic Agents and/or Methotrexate

PharmaChild
Start date: December 2011
Phase: N/A
Study type: Observational

BACKGROUND: Juvenile idiopathic arthritis (JIA) is the most common chronic paediatric rheumatic disease (PRD) and an important cause of short and long-term disability. Although none of the available drugs for JIA has a curative potential, prognosis has greatly improved as a result of substantial progress in disease management. The therapeutic treatment of children with JIA encompasses the use of NSAIDs and intra-articular steroid injections. In those patients not responding to NSAIDs, methotrexate (MTX) has become the disease modifying anti-rheumatic drug (DMARD) of first choice worldwide. For children not responding to MTX, biologic agents recently have become treatment options. PATIENTS AND METHODS: 3-10 year observation study related to children with JIA undergoing treatment with MTX or biologic agents with the following objectives: 1. To create a long-term observational registry of a large population of prevalent and incident cases. 2. Use the accumulating data in the registry to conduct (i) a pharmacovigilance/safety study (primary endpoint) and (ii) estimate effectiveness (frequency and magnitude of response, disease activity over time inhibition or slowing of joint erosions and other radiological evidence of disease progression,), and (iii) estimate adherence to the various treatment regimens. Data from the registry will be used to compare safety and effectiveness profiles amongst the patient cohorts. 3. To identify clinical and laboratory predictors of safety, response to therapy, including remission This project has retrospective (first 3 years) and prospective components (up to 10 years) and will be conducted by the participating centres of the more than 50 countries belonging to the Paediatric Rheumatology INternational Trials Organisation (PRINTO certified ISO 9001-2008, www.printo.it), or the Pediatric Rheumatology European Society (PRES at www.pres.org.uk). The main role of these organisations is to provide a scientific basis for current treatments of paediatric rheumatic diseases. The overall hypothesis to be tested is: • Biologic agents ± MTX agents are able to maintain an acceptable safety profile in the long term in children with different JIA categories while achieving clinical remission and prevent/stop joint erosion development over time. The overall aims are to establish the long term safety of biologic agents and MTX, and their relative effectiveness in children with JIA who need treatment with second line agents.

NCT ID: NCT01358383 Completed - Clinical trials for Juvenile Idiopathic Arthritis

Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers

Start date: May 2011
Phase: Phase 1
Study type: Interventional

This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult volunteers.

NCT ID: NCT01357668 Recruiting - Clinical trials for Juvenile Idiopathic Arthritis

An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

Start date: January 30, 2013
Phase:
Study type: Observational

The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.

NCT ID: NCT01287715 Recruiting - Clinical trials for Juvenile Idiopathic Arthritis

Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis

ABC-STOP
Start date: January 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached. Goals: 1. to investigate in a randomized controlled trial: - which proportion of JIA patients in remission can successfully discontinue etanercept compared to JIA patients in remission who continue etanercept; - if time in remission on etanercept is an important factor in retaining remission after discontinuation of etanercept. 2. to investigate in alle JIA patients who discontinue etanercept (including the control group): - predicting factors (patient or disease characteristics, including time in remission, and MRP8/MRP14) for successfully discontinuation of etanercept; - the disease course after discontinuation of etanercept (time to flare) and the effect of restarting etanercept after flaring.

NCT ID: NCT01230827 Terminated - Clinical trials for Juvenile Idiopathic Arthritis

A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.

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: NCT01145352 Completed - Clinical trials for Juvenile Idiopathic Arthritis

Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]

Enbrel-JIA
Start date: July 2009
Phase: N/A
Study type: Observational

This surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated ENBREL as a treatment for active polyarticular JIA. 1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious adverse events 2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.

NCT ID: NCT01015547 Completed - Clinical trials for Juvenile Idiopathic Arthritis

Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis

ACUTE-JIA
Start date: May 2003
Phase: Phase 3
Study type: Interventional

The objective of this study is to compare in very early polyarticular juvenile idiopathic arthritis (JIA) the efficacy, safety, and cost-benefit-ratio of three treatment strategies: biologic combination, combination of conventional disease-modifying drugs (DMARDs), and methotrexate alone.

NCT ID: NCT01011179 Completed - Clinical trials for Juvenile Idiopathic Arthritis

Internet Self-Management Program With Telephone Support for Adolescents With Arthritis

Start date: November 2008
Phase: N/A
Study type: Interventional

This study will evaluate the feasibility of "Teens Taking Charge: Managing Arthritis On-line" intervention that will help adolescents with arthritis to better manage their disease and improve their health-related quality of life (HRQL).