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Arthritis clinical trials

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NCT ID: NCT04324892 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study

Start date: July 12, 2020
Phase:
Study type: Observational

Objectives: To elucidate the effects of achieving sustained simple disease activity index (SDAI) remission in the progression of joint space outcomes using high-resolution peripheral quantitative CT (HR-pQCT) in patients with early rheumatoid arthritis (ERA), and what the independent effects of erosion /JSW progression are on patient's function. Hypothesis to be tested: Effective control of inflammation in ERA patients who can achieve sustained SDAI remission will have less progression of joint damage then patients who cannot achieve sustained SDAI remission. Design and subjects: 110 consecutive ERA patients will participate in this 1-year prospective, hospital-based, cohort study. Study instruments Metacarpophalangeal joints 2-4 will be measured using HR-pQCT Interventions All participants will receive 1-year tight-control treatment according to a standardized protocol aiming at SDAI remission. Physical function will be assessed by Health Assessment Questionnaire (HAQ) at each visit. HR-pQCT and radiographs will be performed at baseline, 6 (HR-pQCT only) and 12 months. Quantitative analysis of joint space width (JSW) and volume, erosion number and volume, and marginal osteosclerosis (bone apposition at the base of the erosion) will be evaluated by HR-pQCT. Radiographic progression will be scored using van der Heijde-Sharp (SvdH) score. Outcome measures: The primary outcome is the change in JSW and volume over a period of 12 months. Main secondary outcomes include changes in the i) number and size of erosion, ii) SvdH score and iii) HAQ over a period of 12 months. Expected results: Patients who can achieve sustained SDAI remission will have less joint damage and functional loss compared

NCT ID: NCT04321798 Completed - Clinical trials for Rheumatoid Arthritis

Promoting Engagement in Physical Activity in Early Rheumatoid Arthritis: Proof of Concept Study

PEPA-RA
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

People with rheumatoid arthritis have indicated that they would like better support to remain physically active following diagnosis and would welcome a physical activity programmes delivered outside of a secondary care setting by a physiotherapist. With patient input, and based upon previous research in other long term conditions, a physical activity intervention was developed by the researchers for delivery by musculoskeletal physiotherapists in a primary care setting. This proposed proof of concept study will investigate the new intervention and inform a future randomised controlled pilot trial. Four Band 6 musculoskeletal physiotherapists will be trained to deliver the intervention. Subsequently up to 32 patients with a recent diagnosis of rheumatoid arthritis (6 -24 months previously) will be recruited. Each physiotherapist will deliver the 12-week intervention package to a group of 6-8 participants. The participants will be asked to complete some outcome measures at the beginning of the 12-week intervention and again at the end. Following the 12-week programme some of the patients will be asked what they thought of the programme and the outcome measures and whether they have any suggestions for improvement. Those that did and did not complete the programme will be included to ensure a wide range of views. The treating physiotherapists will also be asked about their experiences of delivering the programme as well as what they thought of the training. Based upon these findings the programme will be refined and if appropriate further funding sought to carry out a pilot randomised controlled trial.

NCT ID: NCT04321629 Recruiting - Knee Osteoarthritis Clinical Trials

Knee Arthritis Treatment With Autologous Fragmented Adipose Tissue and PRP - Comparison of Two Treatment Methods

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

This is a prospective, randomized, controlled study. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or PRP and to compare the efficacy of both therapeutic methods. We hypothesize that adipose tissue injections will improve patients' quality of life and functional status and will decrease pain level significantly more than PRP injections. In addition to the functional tests and muscle strength measurement, the patient reported outcome measures (PROMs) of the knee joint function and quality of life will be used to assess each participant. The same inclusion criteria have been established for an Experimental Group (subjects treated with autologous fat tissue) and a Control Group (subjects treated with PRP). Those criteria consist of: symptomatic knee OA, age between 45 and 65 y.o., Kellgren- Lawrence grades I - III OA, no or minimal positive effects of previous conservative treatment (rehabilitation, hyaluronic acid injections, steroid injections). Those patients who meet inclusion criteria will be allocated to Fat Tissue Group or PRP Group randomly. Patients will be assessed five times: before treatment and 1, 3, 6 and 12 months after the treatment. The PROMs consist of the four questionnaires: The Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee 2000 (IKDC 2000), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (21,22), the Health Questionnaire EQ- 5D- 5L. Moreover, three functional tests will be performed to assess patient's functional status: The Timed Up and Go Test (TUG), The 5 Times Sit to Stand Test (5xSTS), The 10m Walk Test (10mWT). To assess strength parameters of the knee flexors and extensors the Maximal Voluntary Isometric Contraction (MVIC) will be measured. Each test will be supervised by the same one physiotherapist to avoid any interexaminer bias and discrepancies during testing.

NCT ID: NCT04321291 Recruiting - Clinical trials for Rheumatoid Arthritis

Information and Acceptability of Biosimilars

BIOSIMINFO
Start date: July 2, 2020
Phase: N/A
Study type: Interventional

Patients with rheumatoid arthritis or spondyloarthritis, currently treated or about to be started with anti-TNF original drug adalimumab or etanercept will be included and randomized to either " information leaflet only " or " information leaflet + nurse information " arms, just before they see their rheumatologist for periodic assessment of disease and treatment. Patients from the " information leaflet only " arm will be distributed individually a dedicated leaflet with written generic informations about the use of biosimilars in rheumatic diseases (individual and societal advantages, pharmaceutical development, scientific efficacy and safety results). Patients from the " " information leaflet + nurse information " arm will be delivered the same leaflet, and additionally offered to have a dedicated individual interview with a specialist nurse, who will orally discuss informations about biosimilars based on a standardized talk, completed by answers to any questions by the patient. The rheumatologist will then propose, unless inappropriate based on clinical evaluation of the patient, a change in the treatment of patients from the original drug to the corresponding biosimilar. The primary outcome will be the observed proportions of patients actually receiving the biosimilar drug at the 6-months follow-up visit in the 2 compared arms. Secondary outcomes will be average time spent by the nurse to adequatley inform the patient, the proportion of patients from the intervention arm who have actually asked for the nurse information interview, and the reasons for refusal of biosimilars, when appropriate.

NCT ID: NCT04315818 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

The Relation Between Macrophage Migration Inhibitory Factor (MIF) and 25(OH) Vitamin D3 Serum Levels in Rheumatoid Arthritis

Start date: March 2021
Phase:
Study type: Observational

Rheumatoid Arthritis is a chronic debilitating inflammatory autoimmune disease of unknown etiology .

NCT ID: NCT04314544 Recruiting - Clinical trials for Active Psoriatic Arthritis

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

Start date: July 1, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)

NCT ID: NCT04314531 Active, not recruiting - Clinical trials for Active Psoriatic Arthritis

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

Start date: July 1, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA .

NCT ID: NCT04312815 Recruiting - Clinical trials for Rheumatoid Arthritis(RA)

A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX

Start date: December 28, 2017
Phase: Phase 3
Study type: Interventional

- To demonstrate that SM03 added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Chinese RA participants with an inadequate response to MTX. - To assess the safety of SM03 added to MTX in Chinese RA participants with an inadequate response to MTX

NCT ID: NCT04311567 Terminated - Clinical trials for Rheumatoid Arthritis

Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease

PULMORA
Start date: November 7, 2020
Phase: Phase 4
Study type: Interventional

Pulmonary abnormalities are present in up to 60% of patients with early rheumatoid arthritis (RA), and up to 10% of the patients will develop clinical interstitial lung disease (ILD). Recent data indicate that inhibition of Janus kinase is beneficial for this extra-articular manifestation. Our goal is to determine whether tofacitinib is an effective and safe treatment, compared to standard-of-care methotrexate, for subclinical and clinical ILD in patients with early RA. The study also explores disease mechanisms in lungs and joints, to identify potential biomarkers for diagnosis, prognosis, and response to treatment of RA-ILD.

NCT ID: NCT04309344 Recruiting - Clinical trials for Glenohumeral Arthritis

Biological Effects of a Bipolar Radiofrequency-based Device Over Shoulder Cartilage

Alexsen
Start date: November 19, 2019
Phase: N/A
Study type: Interventional

In the non-weight bearing glenohumeral joint, focal chondral defects are encountered infrequently and are usually found in association with other pathologies, such as glenohumeral instability, postoperative chondrolysis, focal osteonecrosis, septic arthritis, osteochondritis dissecans, and rotator cuff tears. Several studies revealed that approximately one-third of patients with rotator cuff disease have concomitant articular cartilage lesions. Because the glenohumeral articular cartilage is one of the thinnest in the body, the overall accuracy of non-contrast MRI in detecting glenohumeral articular cartilage lesions is moderate and it is difficult to have an accurate characterization of a lesion my MRI. So, currently, arthroscopy is considered the ''gold standard'' for glenohumeral cartilage assessment. Even if the literature lacks high-quality evidence regarding the nonsurgical and surgical treatment options for patients with shoulder chondral defects, in these scenarios, where, in our experience, the most of the lesions are small, diffuse and of ICRS grade 2 or 3 (non-full thickness), arthroscopic debridement is a good option for addressing glenohumeral chondropathy. The main drawbacks with this type of procedure are the removal of underlying healthy cartilage and the potential lack of chondral surface smoothing. Alternatives used to perform arthroscopic chondral debridement is thermal application, carried out by the use of laser devices or the application of monopolar or bipolar radiofrequency (RF). As regards the glenohumeral joint, there are several studies that underlined the potential benefit of arthroscopic debridement in glenohumeral chondropathy and early stage of osteoarthritis, but the type of debridement used in all these studies was mechanical or not specified. Because recent studies showed that Compared to conventional MD, 50° RF treatment appears to be a superior method based on short- and medium-term clinical outcomes and the progression of knee osteoarthritis [11], we want to specifically evaluate the effects of RF in patients with grade II or III chondropathy found during arthroscopy for rotator cuff disorders.