Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis
Rheumatoid ArthritisAdalimumab is one of the pharmacological treatments for rheumatoid arthritis (RA) of more recent marketing authorization, and as a result of this, there are only efficacy and safety data from clinical trials with controlled conditions.The study will evaluate the safety and effectiveness of adalimumab in the common clinical practice of RA treatment in Spain, with several types of patients showing concomitant treatments or diseases and compliance. Among the tumor necrosis factor antagonists safety studies, adalimumab safety has been the less investigated in the common clinical practice because of, as a result of its recent marketing, it was not included in the BIOBADASER (Data Base for Biological Products in Spain, Rheumatology Spanish Society), Biologic Products Database of the Spanish Society of Rheumatology ) in which was determined an association between infliximab therapy and the risk of developing active tuberculosis. To ensure the maintaining of the strict common physician practice (no prescription induction), and following the recommendations of the SER (Sociedad Española de Reumatología, Spanish Society of Rheumatology) consensus documents, it will be selected only those patients that were already in treatment with adalimumab (HUMIRA),(except patients involved in clinical studies with Adalimumab), and had shown good response, or those that fulfilled treatment indication in accordance with the SER recommendations and following the Summary of Products Characteristics of adalimumab (HUMIRA).
Treatment Efficacy and Toxicity in Rheumatoid Arthritis Database and Repository
Rheumatoid ArthritisTo stimulate collaborative efforts of federal funding agencies, voluntary health agencies, professional organizations and industry partners to enable creation of a large, sustainable database and repository to better understand the molecular basis of treatment and rapidly accelerate translational research in RA.
Observation of Treatment With Certolizumab Pegol in Daily Practice
Rheumatoid ArthritisThis is an observational, non-interventional, non-comparative, post-authorization safety study to evaluate efficacy and long-term safety of Cimzia in adult patients with RA in need of treatment with a biological product.
Low Density Lipoprotein Cholesterol (CLDL) as a Cardiovascular Disease Risk Factor in Rheumatoid...
Rheumatoid ArthritisCardiovascular DiseaseThe investigators hypothesize that cLDL levels are elevated in RA patients and represents an important mechanism for accelerated atherosclerosis leading to excess cardiovascular disease (CVD) in rheumatoid arthritis (RA) patients. The purpose of this study is to improve understanding of the reasons for increased cardiovascular diseases (such as heart attack and stroke) seen in patients with rheumatoid arthritis (RA, an arthritis that causes inflammation and destruction of joints). Specifically, the study plans to determine whether a particular type of change in proteins in LDL cholesterol ("bad cholesterol") known as carbamylation is an important risk factor for cardiovascular diseases in RA patients. The study will utilize a case-control study design. A total of 120 subjects (males and females between the ages of 18 and 80) may be enrolled in order to ensure that 100 subjects (50 RA case subjects and 50 age and sex matched controls) complete the study. Procedures will consist of a single visit for each subject during which a screening evaluation, an enrollment evaluation, and a single blood draw will be performed.
Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients...
Rheumatoid ArthritisThe purpose of this study is to assess the impact of patient cost sharing on treatment discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)
Cell Immunity Response to Vaccination Against Influenza in Patients With Rheumatoid Arthritis
Rheumatoid ArthritisThe efficacy of vaccination against influenza in patients with rheumatoid arthritis has been assessed using humoral response. However, the cellular immunity is another important pathway of response to vaccination. The purpose of this study is to evaluate the degree of cellular immunity response to influenza vaccination. Patient with rheumatoid arthritis and healthy controls will participate in this study , will undergo a clinical evaluation the day of vaccination and 4 weeks after. The humoral and cell immunity response will be assessed the day of vaccination and 4 weeks later
Rheumatoid Arthritis Disease Activity Monitor
Rheumatoid ArthritisBackground of the study: Rheumatoid Arthritis (RA) is an autoimmune disease. There are four stages of the disease: Synovial inflammation Swelling of synovium Pannus formation Advanced bone and cartilage destruction Currently, there is no cure for RA, making the disease a chronic condition. RA is more prevalent in elderly and women. With medication it is possible to delay the onset of complications. Over the last decade, the treatment of RA has changed. Where treatment was palliative until pain medication was ineffective, the treatment is now more aggressive with early administration of disease modifying drugs (DMARDs). The treatment for RA is staged. First, the patient receives generic, low-cost drugs. If this treatment becomes ineffective, the treatment is adjusted with different and usually more advanced drugs. Biologics are a category drugs that are considered most advanced and most expensive. For effective treatment, there are two unmet needs. A tool to aid early diagnosis, as this allows early treatment and delay of complications and physical restrictions for patients. A safe, simple and cheap tool to monitor disease progress to allow traceable, operator-independent informed decisions on treatment adjustments. Non-invasive optical methods offer several advantages over existing modalities. Optical contrast can be related to physiological parameters in the body, such as blood concentration and oxygenation. At relevant wavelengths and intensities, optical radiation is completely harmless. The cost of optical methods is low compared to other modalities. An important application, where optical methods can help diagnosis and treatment is detection of inflammation of joints in patients suffering from rheumatoid arthritis (RA). Due to the highly scattering nature of tissue, non-invasive optical methods for medical imaging are limited to the extremities of the human body. For application in joint diseases, this is acceptable, because imaging of hands can provide sufficient clinical information. Objective of the study: Primary objectives: This is a retrospective, nonrandomized controlled observational study, conducted in a single center to evaluate the potential of optical attenuation measurements to establish disease activity for rheumatoid arthritis patients. Secondary objectives: Establish parameters from transient optical transmission measurements of the joint that relate to clinical evaluation results of individual joints Evaluate relation between disease activity (DAS-28 score) and the optical attenuation spectra of the fingers of a patient. Study design: This is a cross sectional, nonrandomized controlled observational study, conducted in a single center to evaluate the potential of optical attenuation measurements to establish disease activity for rheumatoid arthritis patients. Study population: The subject population will be patients visiting the Regionaal Reuma Centrum Eindhoven for rheumatoid arthritis. Patient visiting this center will represent a cross section of RA patients that are taken care of in an outpatient setting. Primary study parameters/outcome of the study: Primary endpoint is a successful measurement of optical attenuation of a joint and the part of the finger next to the joint before, during and after two consecutive restrictions of venous blood flow by means of a pressure cuff. Secondary study parameters/outcome of the study (if applicable): Secondary endpoints are unsuccessful measurements related to early termination of the measurement related to patient discomfort or safety and equipment or software failure.
A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis...
Psoriatic ArthritisBased on published data and according to the approved product label for ankylosing spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days should be effective in psoriatic arthritic patients with axial involvement.
Study Evaluating the Safety of Enbrel (Etanercept)
ArthritisPsoriaticThe purpose of this study is to collect post-marketing information on the safety of Enbrel in Filipino patients.
Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic...
Rheumatoid ArthritisPsoriatic Arthritis3 moreThe aim of this study is to examine the associations between inflammatory disease activity and endothelial function in rheumatoid arthritis (RA) and spondyloarthritis patients treated with methotrexate and Tumor Necrosis Factor alpha (TNFalpha)inhibitor in combination or methotrexate or TNFalpha-inhibitor alone. Further, to look for improvement in endothelial function, and decrease in bone and cartilage destruction during treatment with the combination therapy of TNFalpha-inhibitor and methotrexate in RA and Psoriatic Arthritis (PSA) patients. Last, examine the TNFalpha inhibitors influence on endothelial function and levels of bone and cartilage markers in patients with Ankylosing Spondylitis (AS).