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Arthritis, Rheumatoid clinical trials

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NCT ID: NCT04120831 Recruiting - Clinical trials for Rheumatoid Arthritis

TOLERA: Tolerance Enhancement in RA

TOLERA
Start date: October 7, 2019
Phase: Phase 2
Study type: Interventional

Although anti-citrullinated protein antibodies (ACPA) including anti-CCP2 antibodies are known to promote inflammation and joint destruction in patients suffering from ACPA-positive rheumatoid arthritis, there are currently no therapies available to efficiently eliminate autoantibody production and to re-induce immune tolerance in these patients. However, both a B cell-targeting therapy (Rituximab) and a T cell targeting therapy (Abatacept) were described to lower anti-CCP2 antibody levels and occasionally trigger disappearance of these autoantibodies (sero conversion). By sequentially combining Rituximab and Abatacept, we thus aim to enhance the tolerogenic potential of these drugs and seek to eliminate autoantibody production and significantly lower ACPA titers. This would for the first time correspond to a "deep" immunological remission and a re-induction of immune tolerance.

NCT ID: NCT04086745 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study of Baricitinib in Participants With Rheumatoid Arthritis

RA-BRANCH
Start date: February 14, 2020
Phase: Phase 4
Study type: Interventional

This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis (RA).

NCT ID: NCT04084223 Recruiting - Clinical trials for Rheumatoid Arthritis

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

JAKPOT
Start date: October 10, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04079374 Recruiting - Clinical trials for Rheumatoid Arthritis

Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel

Start date: September 3, 2018
Phase: Phase 3
Study type: Interventional

The Study objectives are: 1. To compare the efficacy and safety of Etanercept, lyophilisate for solution for injection and Enbrel, lyophilisate for solution for subcutaneous injection, which are used as subcutaneous injections at a dose of 25 mg 2 times a week for 24 weeks in combination with methotrexate in patients with rheumatoid arthritis. 2. To prove the therapeutic equivalence of Etanercept, lyophilisate for solution for injection and Enbrel, lyophilisate for solution for subcutaneous injection in patients with rheumatoid arthritis. 3. To evaluate the immunogenicity of Etanercept, lyophilisate for solution for injection.

NCT ID: NCT04078191 Recruiting - Clinical trials for Rheumatoid Arthritis

Comparison of Tc 99m Tilmanocept Imaging With IHC Analysis of CD206 Expression in Synovial Tissue of Subjects With RA

Start date: September 14, 2021
Phase: Phase 2
Study type: Interventional

This study is a comparison of quantitative Tc 99m tilmanocept imaging with IHC analysis of CD206 expression in synovial tissue of RA subjects.

NCT ID: NCT04066803 Recruiting - Clinical trials for Rheumatoid Arthritis

Optimal MTX Dose With Folic Acid Randomized Case-control Trial

MTXFARCT
Start date: August 1, 2018
Phase: Phase 4
Study type: Interventional

This is an open, single-center, randomized,case controlled, prospective study. Previous studies in China lacked data of efficacy and safety of optimal methotrexate (MTX) dose with/without other anti-rheumatoid drugs (DMARDs) in the treatment of rheumatoid arthritis (RA) .Meanwhile there was no study on the optimal folic acid dose in aspect of preventing side effects of MTX. So we designed the experiment below. The research planned to recruit 160 RA patients in Meizhou, Guangdong Province,China. The volunteers had no relief with 10 mg of MTX per week with/without other DMARDs for at least 3 month. They were randomly divided into 1:1 groups. The experimental group would be treated with original dMARDs ,incremental MTX( gradually increased to the optimal dose (0.3 mg/kg) in the first 12 weeks)and folic acid (the dose adjusted as appropriate with range from 5 mg to 90 mg per week) . While the control group would be treated with original MTX(10mg per week) and incremental original dMARDs( gradually increased to the maximum dose in the first 12 weeks). The two groups would keep the 12th week treatment last to the 36th week, and the efficacy and safety indexes would be evaluated during the whole study. The objective of the study was to determine the efficacy and safety of the optimal dose of MTX in Chinese patients with rheumatoid arthritis, and to determine the efficacy and optimal prevention dose of folic acid in Chinese RA patients. It might be helpful for Chinese rheumatologists to use MTX accurately and efficiently to treat RA patients in clinical work.

NCT ID: NCT04002765 Recruiting - Clinical trials for Rheumatoid Arthritis

Factors of ILD in Newly Diagnosed Rheumatoid Arthritis

FIND-RA
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

To determine factors associated with early RA-ILD (which may be asymptomatic). It is planned to recruit all patients with a newly diagnosed RA (symptoms since less than 3 years). In this study, all relevant demographic and clinical data will be collected. All patients will undergo lung function tests and high-resolution CT-scan of the lungs. Blood sample will be collected for measurement of (1) anti-CCP and rheumatoid factor measurement (good clinical practice) and a specific sample for the detection of the MUC5 promoter variant rs35705950. Our aim is thus to identify determinants of RA-ILD in the following population: - Adults aged 18 to 90 years-old - Diagnosis of rheumatoid arthritis (RA) based on ACR-EULAR 2010 criteria - Onset of disease duration at least 1 year and at most 10 years prior to inclusion

NCT ID: NCT03995615 Recruiting - Clinical trials for Periodontitis and Rheumatoid Arthritis

ESTIMATION OF GINGIVAL CREVICULAR LEVEL OF YKL40

Start date: January 2020
Phase: N/A
Study type: Interventional

The presence of YKL- 40 an acute phase protein in both chronic periodontitis and rheumatoid arthritis. However, till date no studies has been done on the levels of gingival crevicular fluid YKL-40 following scaling and root planing, the present study which is first of its kind is designed to detect and estimate the gingival crevicular fluid YKL-40 levels in healthy patients, chronic periodontitis and patient with chronic periodontitis having rheumatoid arthritis at baseline and chronic periodontitis having rheumatoid arthritis 6 weeks post periodontal therapy (scaling and root planning [SRP]). This could throw more light on it and extend our knowledge on its role in both the conditions.

NCT ID: NCT03986918 Recruiting - Clinical trials for Rheumatoid Arthritis

Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System

Start date: June 1, 2019
Phase:
Study type: Observational

The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System.

NCT ID: NCT03980639 Recruiting - Clinical trials for Rheumatoid Arthritis

Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase

Start date: November 20, 2018
Phase:
Study type: Observational

There are very few data on the safety of Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs), especially abatacept which compared to Tumor Necrosis Factor α (TNFα) inhibitors has distinct mechanism of action. Abatacept is a recombinant fusion protein of human Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) and the Fc region of human immunoglobulin gamma-1 (IgG1). This CTLA4-fusion protein blocks the signal of T cell activation by binding to CD80 and CD86. Recently, the investigator's study found in a US cohort of 64,000 patients with Rheumatoid Arthritis (RA) a potential signal for a higher risk of cancer overall and particularly non-melanoma skin cancer with abatacept compared to other bDMARDs (article in press). These results were in accordance with another prospective cohort study of the public health care system in Sweden, showing an increased risk of NMSC in abatacept users compared with TNFα inhibitors. As these results warrant replication, the present study will assess whether abatacept is associated with an increased risk of reporting overall cancer and specific cancer, including breast, lung, lymphoma, cervical, melanoma and NMSC, compared to other bDMARDs.