View clinical trials related to Rheumatoid Arthritis.
Filter by:The purpose of this Non-inferiority Randomized Clinical Trial is to evaluate the effectiveness of RHEUPP App during telehealth follow-up in a population of Rheumatoid Arthritis patients from a Tertiary Rheumatology Service in South Brazil. The main question[s] it aims to answer are: • Using RHEUPP App in telemedicine is not inferior to usual care in terms of means obtained by CDAI. Participants will be stratified by CDAI and then randomized 1:1 for intervention or control group. They will be evaluated at study starting, in 3 and 6 months, an extended evaluation after 12 months of recruitment is predicted. Researchers will compare intervention and control group to detect differences between usual care and Telehealth follow-up and determine if the last is not less effective in our study population of rheumatic patients.
The goal of this prospective single-arm open-label trial is to learn about efficacy and safety of Bortezomib in treating patients with difficult-to-treat rheumatoid arthritis. The main questions it aims to answer are: - Is Bortezomib an effective treatment option for patients with difficult-to-treat rheumatoid arthritis? - Is Bortezomib safe enough in treating patients with difficult-to-treat rheumatoid arthritis? Participants will: - Receive Bortezomib 2 mg per week subcutaneously for twelve weeks in total. - Follow-up at weeks 4, 12, and 24, while biosamples will be collected.
This phase 1 study will consist of two parts: Phase 1a is a single-dose study, and will evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary pharmacodynamics (PD) in healthy participants. Phase 1b is a multiple doses study, and will evaluate the safety, tolerability, PK and preliminary PD in participants with rheumatoid arthritis (RA).
This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown.
Studies have reported that individuals with Rheumatoid Arthritis have a smaller muscle cross-sectional area, pennation angle and muscle thickness than healthy controls. Sarcopenia may decrease physical performance and quality of life in individuals with RA. Therefore, morphologic changes in the quadriceps femoris muscle due to sarcopenia may help us to gain insight into physical function and quality of life. This study aims to evaluate the predictive capacity of morphologic characteristics of the quadriceps femoris muscle for disease activity, physical performance, and quality of life in women with Rheumatoid Arthritis.
The primary purpose of this study is to evaluate the safety and tolerability of intravenous (IV) doses of IMB-101 in healthy volunteers and participants with active RA on a stable regimen of methotrexate.
Rheumatoid arthritis (RA) is a chronic disease affecting about 1% of the worldwide population. RA is characterized by inflammation of the synovial membrane joints, which can lead to the destruction of the osteochondral structures of the joint and cause a number of systemic complications. RA represents a serious medical and social problem in the Russian Federation with a high level of disability. Recently, genetically engineered biological drugs (GIBPs) and Janus-kinase inhibitors (JAK-i) have become a popular component in the treatment of the severe RA, which is reflected in Russian and International clinical guidelines (1,2). Despite the widespread use of these drugs, many patients do not adequately respond to the therapy. According to the clinical guidelines, the assessment of treatment effectiveness is carried out in RA within 3 to 6 months from the start of treatment (1,2). Treatment for GIBPs and JAK-i is expensive. The cost of drugs without consideration of the medical personnel services cost is on average RUB 700,000 - 1,000,000 per year. Prescribing GIBP and JAK-i therapy to patients who do not respond well to the proposed drugs lead to significant costs for the national healthcare system. Thus, the development of effective approaches to predicting the response of patients to drugs from the GIBD and JAK-i groups is urgent. The search for molecular predictors of treatment response before drug exposure is a part of personalized medicine purposed at substantiating the most effective treatment strategies for a particular patient at a given time. "Big data" summarizing clinical, biochemical clinical indicators (metadata) in combination with molecular proteomic and metabolic results are characterized by a high diagnostic and prognostic value, and can provide the choice of effective treatment strategy for a particular patient. Up to nowadays, there are no practical methods for predicting the response to treatment with drugs from the GIBD and JAK groups in the clinical practice of RA. In the present study, it is proposed to develop a new approach to identify patients with the insufficiently expressed immunomodulatory effects of drugs from the GIBP and JAK groups and to recommend replacing them with a drug from another group. It is planned to study the response of patients to the most widely used RA therapy in clinical practice: 1) GIBPs from the group of tumor necrosis factor inhibitors (TNF-i) and 2) JAK inhibitors (JAK-i). These groups of drugs differ in their mechanisms of action on the immune system and are characterized by different therapeutic targets. It is proposed to perform a dynamic scientific study of metabolomic-proteomic changes in blood samples from patients with RA with a follow-up period of 12 months. Monitoring of the molecular changes will be carried out within 7 temporary points of blood plasma sampling: before the appointment of treatment, after 2 weeks, and after 1, 3, 6, 9 and 12 months following the appointment of treatment. Two comparison groups will be investigated (GIBP from the TNF-i, and from the JAK-i group). Each comparison group will include 30 patients. Achievement/non-response to the treatment will be assessed using the CDAI index (≤10.0). Secondary evaluation points for the answer will be: 1. achieving remission of the disease according to the CDAI index (≤2.8); 2. achieving a low disease activity according to the DAS28-ESR index (≤3.2). 3. achievement of disease remission according to the DAS28-ESR index (≤2.6). 4. achievement of the minimum clinically significant improvement in the patient's function in daily life - a decrease in the HAQ index by ≥0.22 points. The proposed novelty of the project is to study the molecular basis of the development of the response in RA patients to immunomodulatory drugs with different mechanisms of action, to create a mathematical model for choosing patients who respond to therapy with drugs of a specific group using mathematical algorithms and neural networks. References 1. Nasonov E.L., Karateev D.E. Rheumatoid arthritis. In the book: Russian clinical guidelines. Rheumatology / Under. Ed. E. L. Nasonova - M .: GEOTAR-Media, 2020 .-- 448 p. - ISBN 978-5-9704-5398-8, p. 17-57. 2. G. Chatzidionysiou K., Dougados M., et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017; 76 (6): 960- 977.doi: 10.1136 / annrheumdis-2016-210715.
A randomised, double blind, parallel group, multicentre study to compare the pharmacokinetics, pharmacodynamics, immunogenicity and safety of Rituximab (Mabscale LLC, Russia) versus MabThera® in patients with rheumatoid arthritis.
The goal of this observational study is to assess Prakriti & Vikriti in patients visiting OPD of IIISM department, SRM hospital. The main question[s] it aims to answer are: - To evaluate Prakriti & Vikriti of patients using Prakriti & Vikriti questionnaire and with digital devices - To correlate the determined Prakriti and Vikriti with the doctor's assessment along with clinical and biochemical parameters Participants will be advised to follow the treating physician's advice on medicines
Primary objective: To determine the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation, at different concentrations and doses, after administration of single subcutaneous doses to healthy male subjects. Secondary objectives: To determine the pharmacokinetic profile of the different SAR153191 drug products administered subcutaneously. To assess the safety of the different SAR153191 drug products administered subcutaneously.