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356 active trials for Rheumatoid Arthritis

Comprehensive Nano - PMCF Study

This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.

Start: October 2013

Impact of Barriers and Facilitators to Physical Activity in Patients With Inflammatory Arthritis

Background: Patients with inflammatory arthritis (IA), such as spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA) are more prone to physical inactivity but derive specific benefits from regular physical activity. Barriers and facilitators to physical activity (B&F-PA) are key elements and knowledge of their correlation to physical activity is essential for developing interventions to promote physical activity that have a greater likelihood of success. Objectives: primary objective will be to measure the correlation of these B&F-PA to physical activity collected through apps. Secondary objective will be to (I) to quantify physical activity collected through apps in IA patients and (II) to observe the link between physical activity, B&F to physical activity and adherence to treatment. Patients and methods: This is an international, multicentric, cross-sectional study. Patients: From the first of September to the first of February 2020, all patients with definite axSpA, RA or PsA, aged above 18 and able to walk, who have a mobile phone compatible with apps that can track steps, who agree to participate and give his oral informed consent and with ability to read and write in the language of the participating country, seen in outpatient visits in the participating centers, will be asked to participate. The planed inclusion was 200 participants. Data collection: clinical data and information about physical activity and B&F-PA will be entered by rheumatologists during or electronically by patients at the same time point. Questionnaire for B&F-PA: a patient reported questionnaire was recently developed for this study in 2019 based on a systematic review to identify the main B&F-PA. A list of questions was generated from the systematic review reviewed and tested for face validity by 11 experts and confronted to 20 patients with IA through a cognitive debriefing. Physical activity: Physical activity will be measured objectively during the last 7 days by apps already installed by default on the mobile phone of participants and subjectively with the International Physical Activity Questionnaire short version (IPAQ-S). Other outcomes: Stage of exercise behavior change and adherence to treatment will also be collected. Planned analyses: Perceived B&F-PA will be described using frequencies. A score will be calculated for each participant representing the limitations or facilities to perform physical activity. Analysis of the physical activity: The distribution of mean number of steps will be assessed visually for outliers. Univariate analysis will be completed between mean number of steps and gender, age, disease and stages of change. Correlation between mean number of steps and IPAQ-S score will be calculated. Link between physical activity and barriers and facilitators: The link between B&F questionnaire score and mean number of steps will be tested using linear regression. Then multivariate regression including demographic variables, psychological status and disease characteristics will be performed. Outcomes of the study: The expected outcomes of the ImBAIA study are a better understanding of B&F to physical activity in patients with IA and their impact to limit or to favor physical activity. We also expect to observe the level of physical activity of an IA population objectively measured with apps. Finally, a validation was expected to use questionnaire of B&F.

Start: September 2019

G7 BiSpherical Acetabular Shell PMCF Study

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.

Start: December 2017

Fibres Supplementation in Rheumatoid Arthritis

Design: Randomized, double-blind, placebo-controlled study with 4 weeks of treatment with either fiber supplements or placebo. Primary outcome: variation in SCFA between baseline and week 4. Secondary outcomes : variations in gut microbiota, disease activity (DAS28, RAID), immune cells (regulatory T and B cells, Th17) and heart-rate variability. Population: 29 patients with rheumatoid arthritis treated with only csDMARDs and a moderate disease activity will be recruited in each arm and 29 controls with mechanic disease (osteoarthritis, tendinitis). Collection: Blood, feces, disease activity and heart rate variability will be collected at baseline and week 4.

Start: September 2020

The Anti-inflammatory Effects of Harkány Medicinal Water

The study aims to provide evidence on the effectiveness of Harkány medicinal water in psoriatic and rheumatoid arthritis patients using subjective and objective methods. It is a cross-over study, so first half of patients will receive medicinal water, the other half will receive tap water treatment, and after 6 months treatments will be repeated, but patients will receive the other type of water.

Start: June 2020

Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan

This study will be conducted in Japan, South Korea and Taiwan to evaluate the optimal dosage of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with rheumatoid arthritis (RA) who have not achieved remission by MTX monotherapy.

Start: April 2018

The Treat-to-target Study of RA Based on Smart System of Disease Management(SSDM)

This study evaluate the Smart System of Disease Management?SSDM?to improve the treat-to-target(T2T) and the safety of drug in the treatment of rheumatoid(RA). All participants will be randomized in the SSDM group and the control group. The patients in the SSDM group will use the SSDM every month and the control group will receive the conventional therapy.

Start: November 2018

Rheumatoid Arthritis Hematological Indices

Rheumatoid arthritis is a chronic systemic inflammatory and autoimmune disease, characterized by disordered immunity, not regulated cytokines and inflammatory infiltration of the synovial joints. It is the most common inflammatory erosive poly arthritis affecting around 0.5-1% of the worldwide population which leads to joint damage and disability

Start: March 2020

CTHRC1: A Biomarker for Evaluation of Rheumatoid Arthritis Disease Activity

The purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity

Start: October 2020

IMPACT: IMPact of Antimalarials on Covid-19 Infections in RAPPORT

This study aims to evaluate the experience of Alberta patients with inflammatory arthritis who participate in the the RAPPORT-ONTRAAC registry during the COVID-19 pandemic, specifically comparing the experience of those taking anti-malarial medications compared to those who do not. This registry includes approximately 2500 northern Alberta patients with inflammatory arthritis who receive highly complex therapies which may be associated with side effects. This program of data collection and research has been evaluating the effectiveness and safety as well as associated health care costs of rheumatoid and psoriatic arthritis patients since 2004. The principle investigators are based at the University of Alberta while the co-investigators are academic rheumatologists at the University of Alberta. The registry has approximately 900 patients taking anti-malarials combined with their complex therapies and ~ 1500 not on anti-malarials in combination with their complex therapies. We aim to perform a case control study evaluating the impact of anti-malarial drugs (eg. hydroxychloroquine and chloroquine) on the development of COVID-19 compared to those patients who are not on anti-malarial drugs over the next 6-12 months. In addition to frequent e-mail surveys screening for the clinical symptoms of COVID-19 and understanding their concomitant arthritis medication use, we will compare the healthcare outcomes of both groups of arthritis patients with and without COVID-19 for the duration of the pandemic. This information will provide critical information beyond an anecdotal level on whether or not anti-malarials truly provide a protective benefit against COVID-19 or reduce the severity of infection. A blood sample from all participants (Covid-19 positive and negative) will be drawn approximately six months into the study for measurement of antibodies to Covid-19 and possible blood types and HLA alleles. Additionally, this study will be linked to another study "Persistence of SARS-Cov2 in immunocompromised patients" which will specifically evaluate COVID-19 serology and nasopharyngeal swab findings in the subset of patients who develop COVID-19.

Start: September 2020

JAKPOT (JAK Inhibitors and Predictors of Outcome in rheumaToid Arthritis)

Rheumatoid arthritis (RA) is a chronic, progressive autoimmune disease associated with inflammation and destruction of joints and systemic effects, which result in significant impact on patient's quality of life and function. Sustained remission or low disease activity is the target to achieve in RA management. Ultrasound (US) is an imaging technique potentially helpful at several steps of the disease. A semi-quantitative (0-3) score of synovitis combining B-mode and Power Doppler abnormalities has been developed (GLOESS), and its responsiveness has been demonstrated. Patients Reported Outcomes (PROs) are important parameters in patient perceived health and are increasingly used in clinical practice. Prediction of therapeutic response to biological and targeted synthetic DMARDs remains a challenge for clinician, due to the potential adverse events and the cost of these drugs. To date, only few clinical and biological tools usable in clinical practice have a prognostic value. US or PRO could have added value for this purpose. Objectives : To determine the predictive added value of the variation of an US score to the variation of the DAS28-CRP (C-Reactive Protein) at 1 month on clinical outcome (low disease activity i.e. DAS28-CRP?3.2) at 6 months, or on therapeutic response at 3 months (EULAR good or moderate response (DAS)), in RA patients starting a treatment with JAK (Janus Kinase) inhibitors (JAKi). To determine the predictive added value of the variation several PROs to the variation of the DAS28-CRP at 1 month on clinical outcome (low disease activity i.e. DAS28-CRP?3.2) at 6 months, or on therapeutic response at 3 months (EULAR good or moderate response (DAS)), in RA patients starting a treatment with JAKi.

Start: October 2019

Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs

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.

Start: November 2018

Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation

The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Most patients with Juvenile Rheumatoid Arthritis benefit from long-term immunmodulatory therapy (DMARD - disease modifying anti-rheumatic drug), more or less combined with regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.The present study will characterize this issue by defining the proportion of patients whose usual treatment of Rheumatoid Arthritis has been modified in relation to the actual sanitary crisis.

Start: April 2020

COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

The trial is a prospective, observational study aiming to identify risk factors for serious COVID-19 infection by evaluating clinical measures and biomarkers of inflammation in patients with inflammatory rheumatic disease hospitalized with COVID-19 compared with control groups.

Start: April 2020

A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products

The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab. The primary objective of this study is to assess the immunogenicity of transitioning subjects with RA to DRL_RI (biosimilar rituximab) from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab To assess the safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.

Start: April 2020

Role of CTHRC1 in Diagnosis of Rheumatoid Arthritis

to detect the role of CTHRC1 biomarker in diagnosis of rheumatoid arthritis and To correlate other well-established rheumatoid arthritis markers (RF& anti-ccp) and CTHRC1 level to see if CTHRC1 can act as a dependent or independent serum marker in prediction of RA status.

Start: August 2020

GOTHA - The Early Arthritis and Psoriasis Study of Region Västra Götaland, Sweden

GÖTHA- The early arthritis and psoriasis study of Region Västra Götaland, Sweden - is a longitudinal observational study, which will prospectively and in parallel follow patients with newly diagnosed rheumatoid arthritis (RA, N=1000), psoriatic arthritis (PsA, N=500) and undifferentiated arthritis (N=100), together with patients with psoriasis (N=500). The study will also recruit healthy controls from the general population (N=3000). The aims of the study are to define predictors for disease course and severity, treatment response, comorbidities, health related quality of life (HRQoL) and health economy. The study is a collaboration between the department of Rheumatology and the department of Dermatology at Sahlgrenska University Hospital in Gothenburg, and the departments of Rheumatology at the hospitals of Alingsås, Borås, Uddevalla and Skövde, in the west of Sweden. All patients with newly diagnosed RA, PsA and undifferentiated arthritis at the Rheumatology centers are eligible for inclusion. Patients with psoriasis will be recruited from the Department of dermatology at Sahlgrenska University Hospital. The patients will be examined at baseline and at one, three, five and ten years. The assessments will include physical examination with evaluation of joints, entheses and skin and validated questionnaires regarding medical history, comorbidities, lifestyle, disease activity, bodily function, socioeconomic factors and HRQoL. Blood samples will be collected. The patients with arthritis will also undergo radiography of the lung, hands and feet, and Cone Beam Computed Tomography (CBCT) of hands and feet.

Start: January 2020

Phenomics in Autoimmune and Inflammatory Diseases

The family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with IAD should be heuristic and help revise the nosography and the understanding of these diseases.

Start: July 2015

Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients

To validate the utility of survivin as a biomarker of pharmacological response to therapeutic intervention in rheumatoid arthritis patients.

Start: November 2017

Music Therapy Model "The Bonny Method of Guided Imagery and Music" on Patients With Rheumatoid Arthritis

The aim of this study is to investigate the effect of music therapy and in particular of the model "The Bonny Method of Guided Imagery and Music (GIM)" in patients with rheumatoid arthritis (RA) in relation to both chronic pain relief and other psychosocial parameters, as well as the effect of the method on caregiver burden.

Start: September 2020