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Arthritis clinical trials

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NCT ID: NCT03977415 Recruiting - Clinical trials for Rheumatoid Arthritis

Interstitial Lung Disease in Early Rheumatoid Arthritis

ILD-Early RA
Start date: March 27, 2018
Phase:
Study type: Observational

The purpose of this study is to determine how interstitial lung disease can be predicted over time in early rheumatoid arthritis. The investigators will study blood and phlegm samples from participants, along with quality of life questionnaires to determine if and how the presence of ILD may impact the participants quality of life over time.

NCT ID: NCT03976245 Recruiting - Clinical trials for Rheumatoid Arthritis

Advanced Therapeutics in Rheumatoid Arthritis (RA)

Start date: March 1, 2020
Phase: Phase 4
Study type: Interventional

This study will evaluate the retention rates of two advanced therapies, Tumour Necrosis Factor (TNF) and Janus kinase inhibitor (JAK) in the treatment of adults with Rheumatoid Arthritis (RA) over a two year period. It will also examine the ability to embed a clinical trial in a clinical situation using an electronic medical record (EMR).

NCT ID: NCT03975673 Recruiting - Hip Arthropathy Clinical Trials

Patient-Specific Techniques for Hip Replacement

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

Background - In the 19th century, Sir John Charnley successfully introduced total joint replacements for hips. In order to prevent implant fixation failure and accelerated polyethylene wear, it was initially recommended that implants were systematically positioned in a "biomechanically-friendly" way, which disregarded most of the individual anatomy (medialized acetabular cup, systematized cup version and inclination, etc.) - While those initial surgical techniques made popular and clinically successful total joint replacements, many complications (aseptic loosening, pain, excessive wear) have remained and mainly the persistence of frequent instability after THA. In response to those complications, many improvements were developed in the area of joint replacement over the last few decades, with one the most recent dating from 2017 and being the development of a surgical technique Rationale - The kinematic alignment (KA) technique for total hip arthroplasty (THA) aims at restoring the acetabular center of rotation and as much as possible the constitutional acetabular anteversion by using the transverse acetabular ligament (TAL) as a reference landmark. Also, the technique aims (1) at making personalized choice for the hip component design, (2) at defining the cup positioning, and (3) at sometimes considering additional spine surgery based on the assessment of the individual spine-hip relation. - KA techniques for hip replacements are relatively new, likely to become popular over time, and their true value remains to be determined.

NCT ID: NCT03971253 Recruiting - Clinical trials for Rheumatoid Arthritis (RA)

Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis

Start date: September 2, 2019
Phase:
Study type: Observational

The objective of this study is to investigate the safety and effectiveness in routine clinical practice and actual clinical setting for all patients with rheumatoid arthritis (RA) treated with peficitinib.

NCT ID: NCT03958370 Recruiting - Arthropathy of Knee Clinical Trials

Validation of Consumer Activity Monitors in Postoperative Total Arthroplasty Patients

Start date: January 8, 2019
Phase:
Study type: Observational

Mobilization and rehabilitation are essential components of a successful functional recovery following total hip and knee arthroplasties. Currently, we have no good measure of how mobile patients are after their surgery. Recent technological advances in personal activity monitors, such as the Fitbit, might provide medical providers and patients the opportunity to more objectively monitor their postoperative mobility and recovery course. However, these consumer activity monitors have yet to be validated in terms of their accuracy and utility for monitoring mobility in the immediate postoperative setting in arthroplasty patients. Our goal is to validate one of the most popular consumer activity monitors, the Fitbit Zip, in the postoperative total joint arthroplasty patient population.

NCT ID: NCT03944096 Recruiting - Clinical trials for Rheumatoid Arthritis

Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Rheumatoid Arthritis Refractory to Methotrexate

FARM
Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

In this 24-week, single center, randomized, double-blind study, the investigators will evaluate the efficacy and safety of fecal microbiota transplantation in patients with active rheumatoid arthritis refractory to methotrexate

NCT ID: NCT03912428 Recruiting - Healthy Volunteers Clinical Trials

Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis

Start date: June 14, 2019
Phase: Phase 1
Study type: Interventional

Background: Inflammation can play a role in diseases like heart disease and rheumatoid arthritis. PET scans can help detect inflammation. Two new drugs may create better PET images. Objective: To see if the drugs [11C]ER176 and [11C]MC1 can help image inflammation. Eligibility: People ages 18 and older with rheumatoid arthritis or idiopathic inflammatory myopathy (IIM). Healthy volunteers enrolled in protocol 01-M-0254 or 17-M-0181 are also needed. Design: Healthy participants will be screened under protocol 01-M-0254 or 17-M-0181. Participants with arthritis or IIM will have a screening visit. This will include: Medical history Physical exam Blood and urine tests Possible CT or X-ray: A machine will take pictures of the body. Healthy participants will have 1 or 2 visits. They may have urine tests. They may take the drug celecoxib by mouth. They will have a PET scan. A small amount of one or both study drugs will be injected through a catheter: A needle will guide a thin plastic tube into an arm vein. Another catheter will draw blood. They will like on a bed that slides into a machine. Their vital signs and heart activity will be measured. Participants with arthritis will have up to 2 visits after screening. They may take celecoxib and have PET scans. Participants with IIM will have up to 3 visits after screening. At 1 or 2 visits, they will take celecoxib and have PET scans. They will have 1 visit where they have an MRI: They will lie on a table that slides into a machine. The machine takes pictures of the body.

NCT ID: NCT03895879 Recruiting - Clinical trials for Rheumatoid Arthritis

Use of Tocilizumab Drug Levels to Optimize Treatment in RA

TODORA
Start date: March 1, 2020
Phase: Phase 4
Study type: Interventional

Tocilizumab concentrations above 1 mg/L are likely to be sufficient for normalizing C-reactive protein (CRP) production in patients with rheumatoid arthritis (RA). In practice, however, a large variability in the concentrations of tocilizumab is found, and a large proportion of patients treated with tocilizumab subcutaneously (sc) have concentrations far above 1 mg/L. These patients can probably lower their doses without losing clinical response. A 52 weeks non-inferiority, multicenter, randomized controlled study will be performed to investigate whether patients with RA with serum trough concentrations of tocilizumab higher than 15 mg/L can increase their dosing interval to every two weeks without losing clinical response. Patients with relatively high trough concentrations will be randomly assigned to continuation of the standard dose or to increase dosing interval to every two weeks. The main objective is to investigate the difference in mean time weighted Disease Activity Score in 28 joints, including erythrocyte sedimentation rate (DAS28-ESR) between the two groups after 28 weeks. It is expected that patients with relatively high trough concentrations can safely increase their dosing interval without losing response.

NCT ID: NCT03863405 Recruiting - Clinical trials for Rheumatoid Arthritis

Metformin Use in Rheumatoid Arthritis

Start date: January 9, 2019
Phase: Phase 2
Study type: Interventional

Metformin has been used clinically for over 50 years, as a glucose lowering agent. Direct and indirect anti-inflammatory effects of metformin have been reported in animal and clinical studies, and this effect is independent of its hypoglycemic effect. Animal studies showed that metformin decreased serum C-reactive protein (CRP) level in atherogenic rabbits and decreased proinflammatory cytokines (interleukin (IL)-1β, IL-6 and tumor necrosis factor (TNF-α) in obese mice . Moreover, metformin also suppressed osteoclastogenesis ; this may partially result from decreased expression of inflammatory cytokines that promote osteoclastogenesis in the arthritic joint. The objective of this study is to evaluate the efficacy and safety of addition of metformin to standard disease modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis.

NCT ID: NCT03853395 Recruiting - Clinical trials for Arthritis, Rheumatoid

BIOTIPRA: BIOmarker-guided Treatment Decisions In Psoriatic and Rheumatoid Arthritis

BIOTIPRA
Start date: May 31, 2019
Phase: N/A
Study type: Interventional

TNFi drugs remain the most prescribed first-line biologics for patients with rheumatoid arthritis (RA). However, up to 40% of RA patients fail to respond to TNFi treatment. One explanation of non-response is the development of anti-drug antibodies and low drug levels. Studies have consistently shown that: 1. Serum drug levels of monoclonal antibodies (such as adalimumab, certolizumab, infliximab) and the presence of anti-drug antibodies in samples taken at 3 and 6 months correlate with subsequent response at 12 months. 2. Non-responders and those who develop anti-drug antibodies are less likely to receive concomitant methotrexate or, if they do receive it, are on lower doses than responder groups. However, it has not been proven that knowing that a patient had low drug levels or anti-drug antibodies would have improved the outcome; neither has it been shown that introducing or increasing the dose of methotrexate would reduce the formation of anti-drug antibodies, thereby improving outcome. Observational data has revealed that RA non-responders, who exhibit adequate serum drug levels and no detectable anti-drug antibodies, have lower probability of response to another agent with the same mechanism of action (MOA), and may benefit in switching to a drug with a different MOA (12). RA non-responders, who have low detectable serum trough levels and detectable anti-drug antibodies, may benefit in switching to a less immunogenic drug (13, 14). These patients may have a predisposition of developing immunogenicity against the introduced foreign protein (12). Neutralising anti-drug antibodies against the TNFi etanercept or the T-cell co-stimulation inhibitor abatacept have not been detected (10, 12, 15). Furthermore whilst the use and dose of methotrexate at initiation of TNFi, has been associated with lower levels of anti-drug antibodies in our work and others (10, 16), it is not known if increasing the MTX dose once immunogenicity has developed reduces anti-drug antibodies and leads to improved treatment response. Whilst algorithms have been proposed based on these tests (4, 17, 18), they have not been confirmed in a randomised controlled trial setting to show that the intervention (testing) is effective. Based on our preliminary work in an observational dataset, this feasibility study will allow us to design a definitive study to answer the important issue of whether pharmacological testing can be utilised as robust biomarkers to optimise future patient outcomes. The next essential step, therefore, is to prove that introducing these tests improves clinical outcome. It is very important to do so because some clinicians are already requesting that their immunology laboratories introduce such tests; yet the tests themselves are expensive and have not yet shown efficacy (19). Conducting a clinical feasibility trial is one of the essential first steps in development of a full clinical trial to undertake process evaluation and assess the proposed study design, required number of participants and ensure optimum project completion. The proposed trial is a clinical feasibility trial with the aim to ensure a realistic assessment and capability to conduct the full clinical trial. Participants with RA, commencing adalimumab or certolizumab will be randomised to determine whether providing test results on adalimumab/certolizumab drug levels and anti-drug antibodies at 4 weeks, 3 and 6 months to clinicians caring for patients with RA (n=15 patients) starting on treatment with adalimumab/certolizumab, improves the course of disease activity, compared to standard care (n=15 patients). Clinicians will be provided with feedback and a treatment algorithm. The feasibility of the study will be assessed by a number of factors including evaluation of recruitment, attrition, data completeness and process evaluation. The results will be used to inform the number of participants required to fully evaluate the intervention.