A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate...
Rheumatoid ArthritisThis is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.
Marine Oils and Arthritis
Rheumatoid ArthritisNSAIDS are associated with adverse GI effects and COX-2 inhibitors have cardiovascular risk. Long-term oral supplementation with fish oil reduce e.g. joint pain in rheumatoid arthritis (R.A) patients, with reduced need for NSAIDS, in addition to being cardioprotective. The aim is to investigate if 4 month supplementation of 15 ml/day of whale blubber oil compared with cod liver oil reduce the intensity of joint pain in patients with R.A (primary outcome). Patients are assessed at inclusion and after study (4 months) during routine polyclinical visit. Patients are called for interview after 6 and 12 weeks. Secondary outcomes are e.g. morning stiffness, quality of life and functional level
The SPECTRA Study
Rheumatoid ArthritisThe purpose of this study is to compare IL-1ra and the combination of IL-1ra and PEGsTNF-RI with respect to their ability to reduce inflammation and bone and cartilage destruction in the synovium of subjects with rheumatoid arthritis.
Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had...
ArthritisRheumatoidThis is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.
A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who...
Rheumatoid ArthritisThis study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3) infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial is 300.
Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism
Rheumatoid ArthritisRheumatoid arthritis disease is believed to be due to immune cells, cells that normally protect the body and are now causing damage to the body. Risk of death is highest in people with twenty or more joints actively involved with disease, positive rheumatoid factor, an elevated sedimentation rate (laboratory measures of active inflammation), and patients with limitation of daily activities (trouble doing simple things like opening a carton of milk). In these high risk patients, life is significantly shortened. Death is usually from heart disease, kidney failure, neck dislocation, broken hip bones, or blood clots to the lung. In this study we use moderate dose chemotherapy (cyclophosphamide and fludarabine) and CAMPATH-1H (a protein that kills the immune cells that are thought to be causing the disease), followed by infusion of blood stem cells that have been collected from the patient's brother or sister (allogeneic stem cell transplant). The purpose of the moderate dose chemotherapy and CAMPATH-1H is to destroy the cells in the immune system and to allow the cells from the patient's brother or sister to grow. The purpose of the stem cell infusion is to restore blood cell production, which will be severely impaired by the moderate dose chemotherapy and CAMPATH-1H, and to produce a normal immune system that will no longer attack the body.
Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid...
Rheumatoid ArthritisThe purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX
Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
Rheumatoid ArthritisThe purpose of this study is to determine the safety, tolerability and efficacy of natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis (RA) receiving concomitant treatment with methotrexate (MTX). It is thought that natalizumab may stop the movement of certain white blood cells, known as lymphocytes, into joint tissue. These cells are thought to cause damage in the joints leading to the symptoms of RA.
Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid...
Juvenile Rheumatoid ArthritisThe primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).
Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy
Rheumatoid ArthritisThe primary objective of this study is to compare the therapeutic response and safety of 3 oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA) who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.