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Arthritis, Rheumatoid clinical trials

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NCT ID: NCT06301373 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Rheumatoid arthritis (RA) is the leading cause of disability in Chinese women. We established a synovial pathology queue in the early stage and proposed a new synovial immunopathology classification. We found that baseline myeloid stromal RA patients had severe conditions and poor outcome. Early identification of synovial myeloid stromal RA patients and intensified treatment are key to improving RA efficacy. This project aims to conduct a randomized, controlled, open label, multicenter clinical study on early intensified treatment of RA based on synovial pathology classification. 130 adult patients with synovial myeloid stromal type of primary treatment moderate to severe active RA were planned to be enrolled in three centers: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Shenshan Medical Center, Memorial Hospital of Sun Yat-Sen University, and Guangzhou Panyu Central Hospital. They were randomly divided into an intensive treatment group and a conventional treatment group in a 1:1 ratio. The intensive treatment group was treated with methotrexate combined with tofacitinib, while the conventional treatment group was treated with methotrexate monotherapy. The expected intervention period is 12 weeks, with a follow-up period of 48 weeks. The primary endpoint is the proportion of subjects who achieved ACR20 at week 12. Secondary endpoint indicators include improvement in disease activity and joint function among subjects at different follow-up points, safety, and the proportion of subjects who experienced joint destruction progression at week 48. This project proposes the concept of achieving precise diagnosis of RA based on synovial pathology classification, and explores the efficacy of early methotrexate combined with tofacitinib intensified treatment for patients with synovial medullary stromal RA who have poor conventional treatment efficacy, providing high-level clinical evidence for achieving precise initial treatment of RA treatment guidelines.

NCT ID: NCT06297694 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Clinical Interpretation and Cutoff Scores for ABILHAND Questionnaire in Rheumatoid Arthritis

Start date: March 2024
Phase:
Study type: Observational [Patient Registry]

In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis.

NCT ID: NCT06295848 Recruiting - Hypertension Clinical Trials

The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients

CARDIRA
Start date: December 15, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment. Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program.

NCT ID: NCT06293365 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

Start date: June 26, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE). A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.

NCT ID: NCT06289114 Recruiting - Clinical trials for Rheumatoid Arthritis

Predictive Utility of a Short-term Improvement in Objectively Measured Physical Activity in Rheumatoid Arthritis (PUSIPA)

PUSIPA
Start date: September 1, 2023
Phase:
Study type: Observational

SUMMARY Background: Several studies have shown physical activity (PA) to be inversely correlated to disease activity in rheumatoid arthritis (RA) patients. However, it is unclear whether improved PA leads to lower disease activity or if low disease activity predicts improved PA in rheumatoid arthritis patients. Furthermore, it is unknown how fibromyalgia (FM) affects this interaction. Objective(s): Our primary objective will be to compare the effect of an immediate improvement in physical activity after one week on the proportion of RA patients achieving low disease activity after 12 weeks of biological treatment. Furthermore, we will explore whether the presence of concomitant FM affects this clinical response (i.e., interaction between FM status and PA response). Design: A prospective cohort study in the form of a target-trial attempting to address a causal question comparing the outcome among the participants with an immediate improvement in physical activity, relative to individuals without. Setting and patients: Biologically naive RA patients initiating biological treatment are consecutively enrolled. PA is quantified by accelerometry one week prior to, one week after, and after 3 months of biological treatment. Sample size: 100 RA patients starting biological therapy is planned enrolled in the study. Measurements: RA patients will be divided into two groups depending on their improvement in physical activity after onset of biological treatment. The percentage of time spent in moderate-to-vigorously physical activity (MVPA) i.e., the percentage of time a patient is in motion [walking, running, bicycling, or swimming] is measured prior to, one week, and approximately 3 months after biological treatment onset, respectively. The MVPA ratio (MVPA After biological treatment/MVPA Before biological treatment) will divide patients enabling a contrast between two groups: Those with high improvement considering MVPA (after 1 week; the upper tertile of MVPA ratio of the sample) and those without. Treatment response (achieving a disease activity score < 3.2) after approximately 3 months from baseline will be analyzed as the contrast between groups.

NCT ID: NCT06284200 Recruiting - Sarcopenia Clinical Trials

Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis

Start date: June 23, 2023
Phase:
Study type: Observational [Patient Registry]

introduction: In this study, the presence of sarcopenia in cases with early rheumatoid arthritis and established rheumatoid arthritis will be compared. Materials and Method: According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who meet the 2010 American College of Rheumatology (ACR) / European Alliance of Associations for Rheumatology (EULAR) rheumatoid arthritis (RA) classification criteria will be included in the study.

NCT ID: NCT06277635 Recruiting - Clinical trials for Rheumatoid Arthritis

Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis

NCT ID: NCT06276998 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis

Start date: December 12, 2023
Phase: Phase 3
Study type: Interventional

Brief Summary: This is a randomized, double-blind study comparing LNK01001 to placebo in Chinese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response or Intolerance to biologic DMARDs(bDMARDs). The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of LNK01001 12 mg twice daily (BID) versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 76) is to evaluate the long-term safety, tolerability, and efficacy of LNK01001 12 mg BID in participants with RA who completed Period 1.

NCT ID: NCT06276387 Recruiting - Clinical trials for Arthritis, Rheumatoid

Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis

DREAMER
Start date: January 26, 2024
Phase: N/A
Study type: Interventional

This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to: - Assess patient satisfaction with a mindfulness course - Identify barriers to participation in, or completion of, a mindfulness course - Gather initial information to understand how a mindfulness course impacts RA symptoms Participants will: - Complete online questionnaires - Attend two in-person study visits, involving a brief joint exam and blood draw - Roughly half the participants will have the chance to participate in an 8-week online mindfulness course - Roughly half the participants will be invited to participate in an online focus group following completion of the mindfulness course Researchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with RA.

NCT ID: NCT06273306 Not yet recruiting - Clinical trials for Arthritis, Rheumatoid

Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)

IMIDOC
Start date: March 15, 2024
Phase: N/A
Study type: Interventional

The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up. This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App.