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Rheumatoid Arthritis clinical trials

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NCT ID: NCT04684693 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Effect of Laser Puncture on Rheumatoid Arthritis Patients

Start date: December 25, 2020
Phase: N/A
Study type: Interventional

Studying the effect of laser puncture on rheumatoid arthritis patients

NCT ID: NCT04669340 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

E-learning in Patient Education to Patients With Rheumatoid Arthritis

WEB-RA
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Rheumatoid arthritis (RA) is a chronic inflammatory disease that primarily causes pain, swelling and stiffness in the joints. The disease may reduce normal functioning and thereby quality of life. Patient education (PE), with the aim of supporting patients to self-manage their disease is an important part of the treatment and care to patients with RA. PE supports people in living with RA by offering knowledge of the disease, symptoms and treatment as well as guidance in coping with the disease in everyday life. In recent years, the number of people with RA has risen and in general people lives longer. This places new demands on the healthcare system for alternatives to conventional care, e.g. through web technology and remote care. Often PE is provided through face-to-face interactions with health professionals at the hospital and thus far, only a small number of studies have been conducted within the area of web-based PE targeting people with RA. A few studies within RA and other chronic diseases shows that online tools and online educational programs may enhance patient's knowledge of the disease and treatment and improve self-management and quality of life. Internet and technology is a great part of everyday life, however, variation is seen in computer skills and likewise in health literacy skills. Even so, PE based on web technology may have several advantages, e.g. the accessibility and the possibility to seek for information as needed and repeatedly in familiar surroundings and possibly with relatives. Moreover, the integration of words and images can promote deeper understanding and learning since both auditory and visual channels are used. Possible disadvantages may be related to the absence of face-to-face contact with healthcare professionals. Given the need for alternative solutions to the conventional face-to-face contact, the investigators have developed an e-learning program targeting newly diagnosed patients with RA. The purpose of the program is to support self-management of the disease. The program takes into consideration peoples different competencies and assumptions by presenting information in an easy, inspiring and entertaining way. The program consists of three learning modules covering knowledge of the disease, medication, examinations, complications and daily living with RA, e.g. coping with emotions, pain, fatigue, physical activity, work etc. In keeping with different ways of learning and to support people's different competencies, the program offers a combination of animations, graphics, videos, podcasts, quizzes, written text and spoken words. Given the limited evidence about the effectiveness of web-based PE in RA, the intention behind the study is to evaluate the e-learning program. The project will be divided into three parts. In the first part the effect of the e-learning program will be evaluated. Approximately 200-230 patients from four rheumatology clinics in Denmark will be included. Half of the participants will receive education at home through the e-learning program and the other half will receive conventional education at the hospital. The effect of PE will be evaluated through questionnaires covering self-efficacy, knowledge of RA and medication, medication taking, health literacy skills and quality of life. Additionally, disease activity, physical functioning, pain and fatigue will be measured. Furthermore, the investigators will examine the use of the e-learning program, such as time consumption and completed modules. Finally, telephone contacts from patients to the outpatient clinics will be measured to investigate possible causal relationships between the information provided through PE and the need for additional information or guidance related to self-management. The number of out-patient visits in the clinic will also be measured. In the second part the investigators will explore the perceptions of receiving PE through the e-learning program from the perspective of patients with RA. This will be explored through individually interviews with approximately 20-25 patients. In the third part the complexities in the e-learning program to improve chances of success in implementation of the technology in clinical practice, i.e. outside the project, will be explored. Through focus group interviews with nurses and doctors involved in the project, the investigators will explore perspectives of using the program. The interviews will be based on a framework covering both successes, challenges and failures in relation to the technology, the patient group, values and the organisation. Furthermore, the investigators will revisit the patient interviews from the second part in order to obtain information about these aspects from the patient perspective. The investigators hypothesize that the e-learning PE program will be superior to standard face-to-face PE in improving self-efficacy.

NCT ID: NCT04559412 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Study to Assess the Safety and Efficacy of Enbrel Administered by Sofusa DoseConnect for Rheumatoid Arthritis

Start date: March 15, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label pilot study in patients with rheumatoid arthritis (RA). All patients will receive SOFUSA Enbrel 25 mg once weekly. The dose will be increased to 50 mg if the dose escalation criteria are met during the dose escalation phase of the study.

NCT ID: NCT04539964 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis

RESET-RA
Start date: January 11, 2021
Phase: Phase 3
Study type: Interventional

The RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll 250 subjects at 40 sites. All eligible subjects will undergo the implant procedure. Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 180-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.

NCT ID: NCT04536844 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Telehealth Follow-up in Patients With Rheumatoid Arthritis

Start date: June 15, 2020
Phase: N/A
Study type: Interventional

The main objective of the present project is to test the effect of a customized Patient-Reported-Outcome (PRO)-based telehealth follow-up compared to a conventional pre-scheduled outpatient follow-up to monitor disease activity and expenses associated with the follow-up in patients with RA

NCT ID: NCT04464642 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis

Start date: July 10, 2019
Phase: Phase 4
Study type: Interventional

It is a randomized controlled study

NCT ID: NCT04429776 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Tapering of Biologics in Inflammatory Arthritis Patients in Remission

TAPER
Start date: May 13, 2021
Phase: N/A
Study type: Interventional

Rheumatoid arthritis (RA) and Psoriatic Arthritis (PsA) are types of inflammatory arthritis. They are disabling conditions caused by inflammation in joints that can lead to pain, stiffness, fatigue and joint damage. There is currently no cure but treatment is aimed at reducing joint inflammation. Some of the most promising new therapies work by interfering with the binding of a molecule called tumour necrosis factor (TNF). In recent years, new anti-TNF drugs (such as adalimumab, etanercept and certolizumab) have been developed that block the action of TNF and reduce this inflammation. These drugs are very effective in controlling inflammation for many patients whose arthritis has not responded to other therapies. Some patients can take these medications for a long time. If a patient is stable on their rheumatoid arthritis biologic or biosimilar, tapering the drug is often considered. The investigators are planning to look at drug level and anti-drug antibody testing to guide anti-TNF tapering (reducing) decisions in UK patients with RA who have stable, reduced arthritis symptoms. The investigators think that measuring these drug levels and anti-drug antibodies in blood samples will be useful for guiding this process, but the investigators can't be sure. It is important to do this safely so the patient doesn't experience a flare of their disease symptoms. The study will be used to determine whether a much larger study to assess the usefulness of these measurements would be achievable. This study will assess whether measuring biomarkers (measurable substances in the blood) that may affect a patient's response to treatment. If a patient are eligible to take part, they will be randomly allocated to one of the following groups; - Their Doctor receiving information and treatment advice based on their blood results or - Their Doctor not receiving this information

NCT ID: NCT04397237 Active, not recruiting - COVID-19 Clinical Trials

Prevalence and Seroconversion of COVID-19 in Autoimmune Diseases in Europe

Euro-COVIMID
Start date: June 10, 2020
Phase:
Study type: Observational

The coronavirus disease 2019 (COVID-19) pandemic is a potentially fatal disease that represents a great global public health concern. In European countries such as Spain, Italy, Germany, Portugal, England and France, the pandemic has been of utmost importance. To date, no treatment has been robustly validated, and two theoretically opposite therapeutic strategies are proposed, based either on antiretroviral therapy or on immunomodulating agents. In this complex context, people living with immune-mediated inflammatory diseases (IMID) raise specific concerns due to their potentially increased risk of infections or of severe infections. Among IMID, Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, spondyloarthritis and giant cell arteritis are some key diseases. In this cross-sectional, observational, multi-centric study, the investigators aim to assess both clinical and serological prevalence of COVID-19 among samples of IMID patients in Europe. In parallel, the investigators aim to compare the prevalence of COVID-19 seroconversion across these five IMIDs, their penetration across different 6 European countries (France, Italy, Spain, Germany, United Kingdom and Portugal), and to assess the severity of COVID-19 in these patients. Moreover, changes in treatment will be assessed, including immunomodulatory tapering or discontinuation, its causes over the outbreak period, as well as the incidence of IMID flares and their severity over this same period. Finally, patient's perceptions towards the pandemic will be evaluated and compared to medication beliefs. Data will be collected through questionnaires during medical visit or phone consultation and serological tests will be performed within routine blood collection. As so, all study procedures are comprised within usual care. Through this study the investigators expect to have a better knowledge of the clinical and serological prevalence of COVID-19 in IMID across Europe, along with the psychological, clinical, and therapeutic impact of COVID-19 in this particular patient population.

NCT ID: NCT04378621 Active, not recruiting - Depression Clinical Trials

Effect of Antiinflammatory Treatment Versus Hand Training on Neuropsychiatric Comorbidity in RA-patients

NeuMRA
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate how RA affect the brain structures in RA-patients and if anti-inflammatory treatment that target TNF-α or JAK OR physical training of hands has positive impact on neuropsychiatric symptoms and morphological changes in the brain caused by the disease. The goal of this research project is to improve the knowledge of morphological changes in brain developed in connection to RA and to identify clinical and serological markers to predict development of those changes and finally, to investigate if anti-rheumatic interventions counteract destructive processes in the central nervous system (CNS) and improve the patient's health with respect to functionality, pain experience and psychological well-being.

NCT ID: NCT04349046 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Exception Cementless Hip Stem

Exception
Start date: January 1, 2021
Phase:
Study type: Observational

This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.