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Arthritis, Rheumatoid clinical trials

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NCT ID: NCT03619876 Terminated - Clinical trials for Rheumatoid Arthritis

Effects of Abatacept on Myocarditis in Rheumatoid Arthritis

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

This study aims to evaluate the effects of abatacept, a CTLA4-Ig fusion protein that binds cluster of differentiation antigen 80 (CD80)/86 (B7-1/B7-2), on subclinical myocarditis in rheumatoid arthritis (RA) through its effect on T cell subpopulations. RA patients without clinical CVD, biologic naïve, and with inadequate response to methotrexate (MTX), will undergo cardiac fluorodeoxyglucose (FDG) positron emission tomography (PET)/computerized tomography (CT) imaging to assess myocardial inflammation. Studies that investigate the impact of treatment on subclinical myocarditis in RA, a possible contributor to heart failure, while exploring potential underlying mechanisms (i.e., different T cell subpopulations), are needed for a better understanding of their relevance in the pathogenesis of heart failure in RA and survival improvement in these patients with excess risk for cardiovascular death. If the investigator hypothesis is confirmed and treatment with abatacept decreases and/or suppresses or prevents myocardial inflammation in RA, this will have multidisciplinary implications that could lead to changes in the current management of RA patients at high risk for cardiovascular events. Similarly, identification of T cell subpopulations in RA patients with myocardial FDG uptake will shed light into the underlying cellular mechanisms of myocardial injury and serve to guide the use of therapies that prevent their pathogenicity. The objectives of this study are to compare the change in myocardial FDG uptake in RA patients treated with abatacept vs adalimumab, and identify T cell subpopulations associated with myocardial FDG uptake in each treatment arm. RA patients will be randomized in an unblinded, 1:1 ratio to treatment with abatacept vs adalimumab. A cardiac FDG PET/CT will be performed at baseline and 16 weeks post-biologic treatment. T cell subpopulations associated with myocardial FDG uptake will be evaluated at both points in time with their transcriptional phenotype outlined by RNA sequencing.

NCT ID: NCT03618784 Completed - Clinical trials for Rheumatoid Arthritis

Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis

Start date: July 11, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis

NCT ID: NCT03617250 Completed - Clinical trials for Rheumatoid Arthritis

Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio in Rheumatoid Arthritis

Start date: August 1, 2021
Phase:
Study type: Observational

Rheumatoid arthritis is an autoimmune disease characterized by synovial inflammation and joint destruction that follows a relapsing- remitting course.Disease activity assessment is important for rheumatoid arthritis management .Neutrophil lymphocyte ratio and platelet lymphocyte ratio are associated with inflammatory status and can be used to assess disease activity in rheumatoid arthritis

NCT ID: NCT03616158 Recruiting - Clinical trials for Rheumatoid Arthritis

Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time

RA-LD
Start date: May 10, 2018
Phase:
Study type: Observational

The purpose of this study is to investigate the link between the lungs and rheumatoid arthritis (RA). Additionally, to understand why RA patients get lung disease, how to treat, and prevent the disease.

NCT ID: NCT03615729 Completed - Clinical trials for Genetic Predisposition to Disease

RORC Genetic Polymorphism of Rheumatoid Arthritis

Start date: June 30, 2016
Phase:
Study type: Observational

Three candidate single nucleotide polymorphisms in the RORC2 gene, rs9826 A/G, rs3790515 C/T and rs3828057 C/T were examined together with estimation of nuclear hormone retinoic acid receptor-related orphan receptor variant 2 serum levels to determine their possible association with susceptibility to and clinical phenotype of rheumatoid arthritis in Egyptian population.

NCT ID: NCT03606876 Completed - Clinical trials for Rheumatoid Arthritis

Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects

Start date: June 13, 2018
Phase: Phase 1
Study type: Interventional

It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT1806 Injection vs Actemra® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 138 subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed). The study has a screening period of 7 days. PK blood samples will be collected from subjects to determine the serum concentration of tocilizumab, thus to evaluate the change and similarity of the pharmacokinetics of the three study drugs. The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.

NCT ID: NCT03605251 Completed - Clinical trials for Rheumatoid Arthritis

Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.

Start date: August 30, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.

NCT ID: NCT03604406 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept

BMS-188667
Start date: May 8, 2014
Phase: Phase 2
Study type: Interventional

This investigator-initiated study will serve as a sub-study for the American College of Rheumatology-sponsored VERVE protocol currently funded by the NIH. This double-blinded multicenter randomized pragmatic trial is designed to determine whether Zostavax or Shingrix are safe and effective in patients with rheumatoid arthritis (RA) currently using anti-tumor necrosis factor (TNF) therapies. Inclusion/exclusion criteria for this sub-study mirror that of the parent VERVE trial with the exception of abatacept therapy being allowed. Preliminary data from the VERVE parent protocol enrolling patients using anti-TNF therapy is encouraging in that few patients experienced adverse events (56 adverse events in 50 participants, out of 140 participants in total) and that 96.2% of these adverse events were considered either mild or moderate. Importantly, there have been no instances of vaccine dissemination or zoster events to date.

NCT ID: NCT03599986 Completed - Clinical trials for Active Rheumatoid Arthritis

Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis

CLEAR
Start date: June 16, 2017
Phase:
Study type: Observational

A Phase IV, Multi-Centric, Prospective, Observational Study to Assess the Clinical Efficacy and Safety of Leflunomide in Egyptian Patients with Active Rheumatoid Arthritis. (CLEAR)

NCT ID: NCT03593837 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis

Start date: October 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by swelling, pain, and synovial damage. Effective methods lack in the treatment of RA. A traditional prescription in use for thousands of years in China, Huang Qi Gui Zhi Wu Wu Tang(HQGZWWT)granule is still chosen to relive pain and prevent joint malformation in RA patients. However, no evidence-based medical research has been organized to assess the effectiveness and safety of HQGZWWT granules for RA.