A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab...
Rheumatoid ArthritisThis study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexate(MTX)in patients with active rheumatoid arthritis (RA). The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.
Juvenile Idiopathic Arthritis (JIA) Registry
Juvenile Idiopathic ArthritisJIAThis is a global registry, to evaluate the long-term safety of Humira® in patients with moderate to severe polyarticular Juvenile Idiopathic Arthritis (JIA), that are treated as recommended in the Humira® product label. Patients treated with MTX will be considered a reference group. Patients will be followed in both the Humira® and Methotrexate (MTX) arms for 10 years from the enrollment date into one of the treatment arms.
Single Dose PG102 in Patients With Active Psoriatic Arthritis
ArthritisPsoriaticThe primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves around the body and to explore its effects on the disease.
Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic Arthritis
ArthritisJuvenile Rheumatoid2 moreThe purpose of this study is to see if tocilizumab is safe and effective for treating systemic onset Juvenile Idiopathic Arthritis (soJIA). Another purpose is to see if tocilizumab helps reduce the amount of steroids (prednisone) needed to control symptoms of soJIA.
Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and...
Rheumatoid ArthritisOsteoarthritis6 moreThe purpose of this study is to monitor the performance of a large metal-on-metal bearing from the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery or a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. The Study was terminated with effect from 30th November 2011 following the completion of 2 year follow up assessments for those patients remaining in the study. Please note that prior to this decision DePuy voluntarily recalled the ASR products on 24 August 2010. Additional information regarding this voluntary recall and the follow-up of patients affected by the recall can be found at the following links http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON155761 and http://www.depuy.com/countries_list.
Vagus Nerve Stimulation in Rheumatoid Arthritis
Rheumatoid ArthritisThe purpose of this study is to examine the short-term effects of vagus nerve stimulation (VNS) by auricular stimulation (stimulation of the auricular branch of the vagus nerve which innervates the ear) in rheumatoid arthritis (RA). RA is characterized by a chronic systemic inflammation affecting the joints but also carries an increased risk for extra-articular manifestations as well as other organ manifestations such as cardiovascular disease (CVD), which significantly contributes to morbidity and mortality in this disorder.
A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of...
Rheumatoid ArthritisThe purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of natalizumab in subjects with active rheumatoid arthritis (RA) receiving concomitant methotrexate (MTX)
Rituximab for the Treatment of Early Rheumatoid Arthritis (RA)
Rheumatoid ArthritisRheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling, pain, stiffness, damage, and ultimately loss of joint function. Scientists estimate that about 1.3 million people (0.6 percent) of the U.S. adult population have RA. Current therapies target the immune system early in the disease process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents. Rituximab is a disease-modifying antirheumatic drug (DMARD) recently approved by the FDA for use in combination with MTX for treatment of moderately to severely active RA in patients who have had an inadequate response to TNF-blocking agents, in an effort to try to slow the course of the disease. This study will examine the effects of rituximab on the immune response and disease activity in participants with early RA who have not been treated with any disease-modifying agent. In addition, the safety and tolerability of rituximab in this population will be examined.
Sidus(TM) Post Market Clinical Follow-up (PMCF) Study
Non-inflammatory Degenerative Joint Disease (NIDJD)Avascular Necrosis3 moreThis post market clinical follow-up study is designed to confirm safety and performance of the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty. The safety of the implant will be evaluated by monitoring the frequency and incidence of all kinds of adverse events. The performance will be determined by analyzing the implant survival, overall pain and functional performances (based on Constant & Murley score and ASES score), subject quality of life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component migration) of study subjects who received the Sidus Stem-Free Shoulder. The Sidus Stem-Free Shoulder is not approved for use in the US.
Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost...
Moderate to Severe Rheumatoid ArthritisTo evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.