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Arthritis, Juvenile clinical trials

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NCT ID: NCT00731965 Completed - Clinical trials for Arthritis, Juvenile Rheumatoid

Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Juvenile Idiopathic Arthritis

VAART
Start date: May 2008
Phase: Phase 4
Study type: Interventional

Background: The safety of vaccination in patients with autoimmune diseases using immune suppressive therapy is often discussed. Previous studies in Juvenile Idiopathic Arthritis (JIA) patients showed no increase in disease activity after immunisation with dead vaccines. The safety of the live attenuated Measles, Mumps, Rubella (MMR) vaccination was assessed retrospectively in JIA patients and no increase in disease activity was found. However, this must be prospectively confirmed. In addition, it is unknown whether vaccination is effective, since the immune response to vaccination may be diminished due to immunosuppressive therapy for the underlying disease. Finally, the influence of MMR vaccination on the immune system of JIA patients has not been studied. Among others, regulatory T-cells (Tregs) should control the immune response and prevent destructive autoimmune responses after environmental triggers such as vaccination. Objective: The aim of the present study is to investigate the safety and efficacy of the MMR booster vaccination and its influence on immune regulatory mechanisms in children with Juvenile Idiopathic Arthritis. Method: JIA patients aged 4 to 8 years and treated by the pediatric rheumatology units from various University Medical Centers in the Netherlands, are asked to participate in a prospective study. In the Netherlands, measles-mumps-rubella (MMR) vaccination is included in the National Vaccination Program and is normally administered at age 9. Included patients will be randomised for early vaccination (age group 4 to 8yr at entry of the study) or at age 9 as is routinely done according to the National Vaccination Program. Prior to and after vaccination the investigators will assess disease activity and collect blood. Outcome: During a 12 month follow-up period the investigators will register disease activity and side-effects at different moments in time to determine safety of vaccination. The efficacy of the vaccine will be studied according to antibody levels and function against measles, mumps and rubella in the blood. Tregs will be isolated and their functionality will be determined using the blood cells collected during follow-up. This enables us to study the role influence of vaccination on regulatory mechanisms in our immune system.

NCT ID: NCT00690573 Completed - Clinical trials for Juvenile Rheumatoid Arthritis

Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis

Start date: May 2008
Phase: Phase 3
Study type: Interventional

To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with Polyarticular Juvenile Rheumatoid Arthritis

NCT ID: NCT00652925 Completed - Clinical trials for Arthritis, Juvenile Rheumatoid

A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

Start date: October 2002
Phase: Phase 3
Study type: Interventional

To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.

NCT ID: NCT00642460 Completed - Clinical trials for Juvenile Idiopathic Arthritis

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)

Start date: May 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be randomized 2:1 to receive iv infusions of RoActemra/Actemra (8mg/kg iv for patients >=30kg, or 12mg/kg for patients <30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will be continued throughout. After 12 weeks of double-blind treatment, all patients will have the option to enter Part II of the study to receive open-label treatment with RoActemra/Actemra for a further 92 weeks, followed by a 3-year continuation of the study in Part III in which, for patients who meet specific criteria, an optional alternative dosing schedule decreasing the study drug administration frequency will be introduced. Anticipated time on study treatment is up to 5 years.

NCT ID: NCT00573651 Completed - Arthritis Clinical Trials

Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis

CHASE
Start date: November 2007
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to see if patients with juvenile idiopathic arthritis or seronegative arthritis (and related conditions) mount protective immune responses to the human papillomavirus (HPV) vaccine called Gardasil. The researchers also want to monitor for any increase in disease activity following receipt of the vaccine.

NCT ID: NCT00570934 Completed - Clinical trials for Juvenile Rheumatoid Arthritis

Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA

Start date: March 1995
Phase: Phase 3
Study type: Interventional

2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.

NCT ID: NCT00570661 Completed - Clinical trials for Onset Juvenile Idiopathic Arthritis

Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis

SOJIA
Start date: September 12, 2006
Phase: Phase 2
Study type: Interventional

This study has the following objectives: Primary objective: - To determine the safety and tolerability of oral ITF2357 in patients with active SOJIA with inadequate response or intolerance to standard therapy with oral steroids and methotrexate, with or without previously used biologic agents. Secondary objectives: - to evaluate the effect of ITF2357 on disease activity in patients with active SOJIA - to investigate the possibility of steroid dose tapering in patients with active SOJIA during ITF2357 treatment - to assess the effect of ITF2357 on levels of circulating cytokines - to assess the pharmacokinetic properties of ITF2357

NCT ID: NCT00534495 Completed - Clinical trials for Juvenile Idiopathic Arthritis

Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults

Start date: November 2008
Phase: Phase 2
Study type: Interventional

Systemic juvenile idiopathic arthritis (SJIA) is a type of arthritis that typically occurs before 16 years of age. SJIA usually involves heat, pain, swelling, and stiffness in the body's joints. It can also involve fever, rash, anemia, and inflammation in various parts of the body. Rilonacept is a drug that can reduce inflammation. The purpose of this study is to determine whether a rilonacept drug regimen initiated early is more effective than a similar rilonacept drug regimen initiated 4 weeks later when treating children and young adults with SJIA.

NCT ID: NCT00487565 Completed - Clinical trials for Rheumatoid Arthritis

Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System

Start date: September 2006
Phase: N/A
Study type: Interventional

Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System

NCT ID: NCT00484809 Completed - Clinical trials for Rheumatoid Arthritis

Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children

Start date: March 2004
Phase: Phase 4
Study type: Observational

This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.