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Arthritis clinical trials

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NCT ID: NCT02927509 Completed - Clinical trials for Rheumatoid Arthritis

Evaluation of Tumour Necrosis Factor Alpha (TNFα) Blockers in Early Rheumatoid Arthritis in France

Start date: May 2014
Phase: N/A
Study type: Observational

Aim: To describe 1) The use of TNF blockers in early arthritis in daily clinical practice in France 2) To evaluate symptomatic, structural efficacy, and retention rate over 5 years 3) To evaluate predictive factors for TNF blocker response Type of study: Observational cohort study using cross-section and longitudinal data. Description of the project methodology - Patients: All patients in the ESPOIR cohort (multicentre French cohort study of early RA).A sub-analysis will be conducted among patients satisfying the ACREULAR 2010 criteria. - Data collected: Patient characteristics, Clinical data regarding RA and related pathologies, Characteristics of treatments received The analysis will be conducted using data collected at baseline, 6, 12, 18, 24, 36, 48, 60 months. - Analyses: 1. Frequency of use of TNF blockers: the % of patients initiating TNF blockers will be calculated (Kaplan-Meier method), and the type of TNF blocker will be described, the route of administration, the dosage, the association with other DMARDs and the place of the TNF blockers in the treatment strategy during the first 5 years. 2. Implementation of EULAR recommendations: the percentage of patients that initiate TNF blockers meeting the EULAR criteria for initiation will be estimated, and the concordance coefficient Kappa with regard to such fulfilment and the initiation of TNF blockers will be calculated, and disease severity outcome measures will be compared depending on the fulfilment or not. 3. Identification of potential predictive factors for initiation of TNF blockers: a survival curve (Kaplan-Meier) will be performed. The baseline characteristics of the patients with regard to the initiation of TNF blocker during the first 5 years of the disease will be compared by univariate analysis and Log-rank test will be performed in all variables. A stepwise multivariate analysis (Cox analysis) will be performed. 4. Therapeutical effect:the retention rate over time will be calculated, the changes in different variables will be compared in the group of patients who have received TNF blockers matched (using a propensity score) to 1,2 or 3 patients who have not. The DAS28 and HAQ will be assessed and compared at the short term (after at least 8 weeks of treatment) and long term (last available visit) in groups. The structural efficacy was evaluated by the radiographic progression at last available visit.The drug effect will be identically estimated depending on the TNF blocker used, by calculating the retention rate and comparing DAS28 at short term and long term. 6) Identification of predictive factors for TNF blocker response: To evaluate the impact of baseline demographics and disease conditions on the DAS28 and HAQ response during the first 5 years will be compared by univariate and multivariate analysis. Expected results: Increase knowledge on the optimal use of TNF blocker and on predictive factors for TNF blocker response in early RA patients.

NCT ID: NCT02926651 Withdrawn - Anemia Clinical Trials

Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty

Start date: October 2016
Phase: Phase 4
Study type: Interventional

As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose regardless of their pre-operative risk of transfusion. Therefore the aim of the study is to determine whether or not repeated dosing of oral TXA reduces the post-operative reduction in hemoglobin, hematocrit, number of transfusions, and post-operative blood loss following primary TKA and THA surgeries in patients with low pre-operative hematocrit and high risk for transfusion. The investigators hypothesize that a multi-dose TXA regimen will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regime.

NCT ID: NCT02925338 Completed - Clinical trials for Rheumatoid Arthritis

National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life

ReFLECT
Start date: October 19, 2016
Phase:
Study type: Observational

National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.

NCT ID: NCT02924623 Completed - Clinical trials for Rheumatoid Arthritis

Discrepancies Between Patients and Physicians in Their Perceptions of Rheumatoid Arthritis Disease Activity

DIAPO
Start date: February 1, 2016
Phase:
Study type: Observational

Patients and physicians often differ in their perceptions of rheumatoid arthritis (RA) disease activity, as quantified by the patient's global assessment (PGA) and by the evaluator's global assessment (EGA). The objectives of this study were: 1. to explore the extent and reasons for the discordance between patients and physicians in their perception of RA disease activity 2. to determine if this discordance at baseline is associated with RA outcomes at 1 year (remission, function and structure) in early arthritis (EA) in daily clinical practice. - Patients: from the French cohort of early arthritis (EA) ESPOIR³ (at least 2 swollen joints for less than 6 months, DMARD naïve), fulfilling the ACR-EULAR criteria for RA at baseline Analysis: At baseline, agreement between PGA and EGA (Bland-Altman plot) was assessed. Multivariate linear regression was used to determine the patient and EA features independently associated with discordance (calculated as PGA - EGA). Logistic regression was used to analyze discordance as│PGA - EGA│≥20. Multivariate logistic models were used to determine if discordance at baseline is associated with remissions (Boolean, SDAI and DAS28), functional stability (HAQ≤0.5 and deltaHAQ≤0.25) and absence of radiographic progression (delta Sharp score<1) after 1 year of follow-up.

NCT ID: NCT02922192 Completed - Clinical trials for Rheumatoid Arthritis

Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis

Start date: January 1, 2012
Phase:
Study type: Observational

Purpose: With the existing biologic anti-inflammatory product patents expiring and the FDA approval of new biosimilar and innovator biologics, patients with rheumatologic (RA), psoriatic (PsO-PsA-AS), and gastrointestinal (GI) conditions will have additional therapeutic options. This observational study will describe the patient characteristics of new users of Tumor Necrosis Factor-α (TNF) antagonists, non-TNF- α antagonists, oral DMARD, and non-biologic agents. It will describe in the treatment cohorts outcomes of serious infections that require hospitalization. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator anti-inflammatory biologics.

NCT ID: NCT02919761 Completed - Clinical trials for Arthritis, Rheumatoid

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Start date: November 7, 2016
Phase: Phase 4
Study type: Interventional

This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease. Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR. Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks. A single participant might be involved in the trial for as many as 32 weeks.

NCT ID: NCT02919475 Completed - Clinical trials for Rheumatoid Arthritis

Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis

MOVE-RA
Start date: September 14, 2016
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are receiving background non-biologic disease-modifying anti-rheumatic drug therapy.

NCT ID: NCT02917434 Completed - Obesity Clinical Trials

Effects of Weight-loss Treatment in Obese Patients With Psoriatic Arthritis

VIPsA
Start date: April 2016
Phase: N/A
Study type: Interventional

The study is an open intervention study with the aim to determine the effects of weight-loss treatment with Low-Energy liquid Diet (LED) on disease activity, quality of life and markers of the metabolic syndrome in patients with psoriatic arthritis and obesity.

NCT ID: NCT02915094 Completed - Clinical trials for Rheumatoid Arthritis

Kineret in the Treatment of Rheumatoid Arthritis

Start date: October 2012
Phase: N/A
Study type: Observational

Objective of the study is to gain knowledge about the administration of Kineret in patients with rheumatoid arthritis in the daily routine treatment and not in controlled trials. In the current survey, the investigation of the response rate of Kineret regarding the date of onset of action, the efficacy, as well as the tolerability and safety are of particular interest.

NCT ID: NCT02912221 Completed - Clinical trials for Arthritis, Rheumatoid

Stepping Up For Inflammatory Arthritis

SUFIA
Start date: April 24, 2017
Phase: N/A
Study type: Interventional

This study will examine the benefits of a monitored physical activity program for participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) using a wearable activity device (e.g.fitbit). The goals of this pilot study are to examine 1) whether an incentive is better than no incentive in maintaining an increased level of physical activity and 2) the benefits of physical activity on patient reported disease activity in inflammatory arthritis.