The Norwegian Drug Monitoring Study
Rheumatoid ArthritisSpondyloarthritis5 moreInfliximab and other TNF-inhibitors have revolutionised the treatment of several immunological inflammatory diseases. Still, more than half of the patients either do not respond sufficiently to infliximab therapy or loose efficacy over time. The large individual variation in the serum drug concentrations on standard doses and the development of anti-drug antibodies are thought to be main reasons for these treatment failures. An individualised treatment strategy based on systematic assessments of serum drug concentrations, therapeutic drug monitoring, has been proposed as a clinical tool to optimise efficacy of infliximab treatment. Therapeutic drug monitoring seems reasonable both from a clinical and an economical point of view, but the effectiveness of this treatment strategy still remain to be shown. The NOR-DRUM study is planned as a national, randomised controlled multicentre trial in two parts aiming to assess the effectiveness of therapeutic drug monitoring in order to achieve remission in patients with immunological inflammatory diseases starting infliximab treatment (part A) and in order to maintain disease control in patients on maintenance infliximab treatment (part B). The results of the NOR-DRUM study will hopefully contribute to an implementation of a personalised medicine approach to treatment with infliximab and other biological drugs.
A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis
Axial SpondyloarthritisThe main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).
NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage...
Ankylosing SpondylitisTo evaluate the impact of treatment with a non-steroidal anti-inflammatory drug (NSAID) - Celecoxib - when added to anti-tumour necrosis factor (TNF) therapy - Golimumab - as compared to anti-TNF therapy (Golimumab) alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis (AS).
Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing...
Ankylosing SpondylitisThis study assessed the clinical Assessment of SpondyloArthritis international Society (ASAS) 20 response to secukinumab and evaluated to which extent concomitant nonsteroidal anti-inflammatory drug (NSAID) treatment can be reduced in patients treated with secukinumab or placebo following an initial run-in phase of stable NSAID therapy.
Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses...
Ankylosing SpondylitisBCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During the trial patients with active ankylosing spondylitis will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12. Efficacy and safety parameters will be evaluated.
Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients...
Psoriatic ArthritisAxial Spondyloarthritis1 moreThe purpose of this study was to demonstrate efficacy, including effects on inflammation by magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis for up to 1 year with a primary focus at Week 24, in patients with active Psoriatic Arthritis and axial Spondyloarthritis despite current or previous non-steroidal anti-inflammatory drugs (NSAID) and/or disease modifying anti-rheumatic drug (DMARD) and/or anti-TNFα therapy.
Tai Chi in Spondyloarthritis
SpondyloarthritisOur hypothesis is that tai chi sessions would increase physical activity of patients with Spondyloarthitis. The main objective is to study the effect of tai chi sessions (16 vs.0) on global physical activity of Spondyloarthitis patients, compared to a control group without tai chi.
Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis
Ankylosing SpondylitisThe purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis
16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active...
Ankylosing SpondylitisThis study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.
A Study to Test the Design, Functionality, and Ergonomic Features of the Autoinjector
Rheumatoid ArthritisPsoriatic Arthritis2 moreThe main purpose of this study is to evaluate how well the autoinjector works in a group of people who are likely to use the autoinjector for injecting their medicine in the future. However, no active medicine is given by the autoinjector.