View clinical trials related to Spondylitis, Ankylosing.
Filter by:FoLoMI is a pilot study in which the investigators will seek to determine if gait spatio-temporal and kinematic parameters can explain the evolution of a functional score, the Bath Ankylosing Spondylitis Functional Index (BASFI), at 18 months. The secondary objectives are: (1) to study the relationship between gait parameters measured at T0 and the BASFI at T0, (2) to study the relationship between gait parameters at T0 and the BASDAI at T0, (3) to assess general state of health of the patients and its evolution by appreciating: level of physical activity, state of fatigue, diurnal sleepiness and quality of life, and (4) to compare spatio-temporal gait parameters between patients and healthy controls.
The purpose of this study is to assess the safety of subcutaneous (SC) golimumab in participants with active Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) over 24 weeks.
In Canada and worldwide there is a need for updated independent real-world comparative effectiveness and safety data related to biologic drugs including biosimilar drugs. Biosimilar drugs hold potential to improve access to needed therapies at reduced cost enabling savings to be reallocated to other needs. However updated real-world evidence on comparative effectiveness and safety of biosimilar drugs is lacking. Investigators aim to demonstrate feasibility of creating network of clinical cohorts and other resources to provide real-world information on use of biosimilar drugs in Canada. The core revolves around clinical datasets but investigators will complement with other data sources. Investigators will review data from National Prescription Drug Utilization Information System database that contains prescription claims-level data collected from publicly financed drug benefit programs in different provinces to conduct an environmental scan of the use of biosimilars and respective legacy drugs and other anti-Tumor Necrosis Factor agents covered by provincial drug plans from 2014-2017. Initial analysis will help to confirm that use of biosimilars is lower than corresponding legacy drugs. Biologic drugs are relatively new and expensive drugs; biosimilar medicines are similar to original biologic drugs but cost less. If patients receive biosimilar drugs rather than originator biologics healthcare systems may be able to save money. Those savings can be used for other health care needs to benefit more Canadians. However investigators do not have detailed information on safety and effectiveness of these biosimilar drugs. The aim of study is to compare safety and effectiveness of biosimilar drugs to originator biologic drugs. Investigators will study patients with inflammatory rheumatic diseases (RA and AS) and Inflammatory Bowel Disease (CD and UC) and across Canada on these drugs. Primary focus is on patients without history of biologic drug use but investigators will also study patients switching to biosimilar drug from an originator biologic drug. Investigators will measure how long patients stay on treatment, if patients require new treatment, if the patients' disease control improves and occurrence of side effects such as infection that could be related to these drugs.
Ankylosing spondylitis (AS) patients often have subclinical gut wall inflammation. Gut dysbiosis has been associated with both AS and Crohn disease, both of which have several features in common. Gut dysbiosis is associated with specific microbial profile in AS patients. Fecal microbiota transplantation (FMT) has been proved to be safe and effective treatment for recurrent Clostridium difficile infection, and the change in gut microbiota is shown to be long lasting. It has led to interest to study its effect on different inflammatory conditions associated with gut dysbiosis. We hypothesize that dysbiosis in AS leads to inflammasome overactivation on gut mucosa. We aim to study the role of gut inflammation, gut microbiota and inflammasome activation in pathogenesis of AS, and the effect of FMT on these factors, as well as clinical activity, in AS patients.
The aim of the study is to investigate the effectiveness stretching exercises in ankylosing spondylitis.
A study to describe the one-year persistence in participants treated by Flixabi (infliximab) or Imraldi (Adalimumab) as prescribed by the physician for each of the 5 following indications: Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD) [adults and children] and Ulcerative Colitis (UC) [adults for both treatments and children only for Flixabi].
A study of axSpA and AS receiving Secukinumab in a treat-to-target strategy.
TNF- α receptor inhibitors have been used widely in practice and are well developed in China. Anbainuo is a bio-similar recombinant TNF-α receptor: IgG Fc fusion protein, approved in 2015. Up to now, Anbainuo is well applied in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS). Although the phase II and III clinical trials both indicated that Anbainuo can effectively control the disease activity with good tolerance and safety in RA and AS patients, there is no sufficient clinical evidence in the real world. Thus, the objective of this study is to evaluate, under the actual conditions of use, dosing patterns of Anbainuo. Investigators plan to recruit 1000 adult patients with RA or AS and to follow them for 48 weeks. It is hypothesized that this study would reflect real clinical conditions (efficacy and safety assessment) of using Anbainuo in RA and AS patients.
The main objective of this trial is to search for biomarkers associated with the success of adalimumab treatment in order to generate an algorithm to predict the response to this treatment at 6 months in spondyloarthritis and to define its metrological properties on this cohort. The algorithm will allow to better target patients who will have an important benefit/risk ratio for adalimumab treatment.
Rationale. Coxitis in AS is inflammation of hip(s) affecting significant number of patients. It is associated with worse function and more expressed axial disease requiring hip replacement at end-stage. Number of studies dedicated to coxitis treated with TNF alpha inhibitors is very limited. Primary objective. To evaluate change of functional impairment in AS patients with coxitis from baseline to 12 months of therapy with golimumab by BASFI in daily clinical practice Study design. This study is a non-interventional prospective observational cohort study conducted in multiple centers across Russia. Study population. Patients with ankylosing spondylitis (according to the modified New York criteria) with coxitis newly prescribed golimumab during the course of usual clinical care will be enrolled and followed prospectively for 24 months with data collection at the approximate time points: baseline (pre-treatment) and consequent every 6 months. Patients will receive golimumab as prescribed in regular clinical practice. Statistical Methods. Quantitative variables will be tested for normal distribution using the Shapiro-Wilk test. The hypothesis of equality of variances will be tested using Levene's test. Quantitative variables matching a normal distribution will be described in terms of the mean ± standard deviation, and values outside of the normal distribution as medians, 25% and 75% quartiles. Qualitative variables will be presented in the form of percentages of the absolute value N. Sample Size and Power Calculations. Sample size calculation is based on data from GO-RAISE registration study in which golimumab was evaluated in patients with AS. The baseline BASFI was 5.0 which changed by mean (± SD, standard deviation) −2.5 (± 2.12) at week 52 (approximately 12 months). The analysis of the data shows that the minimum necessary sample size should be 18 patients to show a statistically significant change of BASFI from baseline to 12 months. On this basis and considering that the dropout rate over the two years is expected to be 30%, we decided that the necessary number of patients to be included into protocol should be 39 individuals. It is expected that around 27 patients will be included in the patient set completing the study. Power of the study is 90% with formula evaluation P = 1-β where P is power and β is type 2 error = 10%.