View clinical trials related to Arthritis, Rheumatoid.
Filter by:To characterize the pharmacokinetic profile of the Test product - Methotrexate Tablets USP, 2.5 mg of Amneal Pharmaceuticals, compared to that of the corresponding Reference product - Methotrexate Tablets USP 2.5 mg manufactured for DAVA Pharmaceuticals, Inc. in patients with mild to severe psoriasis or rheumatoid arthritis, who are already on established regimens of 2.5 mg every 12 hours for three doses per week under fasting conditions, and to assess their bioequivalence.
The main purpose of the study was to compare rheumatoid arthritis symptom improvement in participants who were given ABP 710 to those who were given infliximab, 22 weeks after starting treatment.
Influenza, a vaccine-preventable respiratory disease, is ranked 8th among the causes of death in the Canadian population. Among rheumatoid arthritis (RA) patients, the incidence of both seasonal influenza and serious influenza-related illness (IRI) are increased. Despite being a high priority group targeted for vaccination, the diagnosis of RA and other patient-specific factors (i.e. older age, treatment, current smoking) are linked to impaired vaccination responses. Thus the burden of influenza among people with RA is disproportionally high, and interventions to improve responses to influenza vaccination are urgently needed. Strategies to optimize protection in another vulnerable group, the elderly, include the use of quadrivalent vaccines, higher antigen doses, and adjuvants. A high-dose, trivalent, inactivated influenza vaccine (HD-TIV) has recently been shown to have a similar safety profile to standard dose vaccine (SD-TIV) with improved immunogenicity and protection in adults ≥65 years of age. Whether or not analogous strategies to improve responses to influenza vaccine will enhance protection in people with RA is unknown. The investigators hypothesize that the use of the HD-influenza vaccine will improve vaccine-induced protection (i.e. seroconversion and seroprotection) in people with RA compared to SD-influenza vaccine. The investigators propose to conduct a stratified, randomized, modified double blind, active-controlled trial to assess immune responses to two commercial influenza vaccines containing different antigen doses in individuals with RA.
Rheumatoid arthritis (RA) patients in remission with a combination of TNFinhibitors (TNFi) and methotrexate (MTX) often express their wish to stop MTX treatment because of side effects. Given the efficacy of TNFi it is conceivable that in early RA patients in remission with methotrexate (MTX)/TNFi stepwise discontinuation of MTX prior to TNFi is superior in maintaining sustained remission and reaching drug free remission as compared to discontinuation of TNFi prior to MTX. Objective: To investigate whether tapering MTX first, then the TNFi golimumab (GOL), is more efficacious than tapering GOL first, then MTX, in sustaining remission and reaching drug free remission. Study design: multicenter, open label clinical trial in very early RA patients. Remission will be induced by an open label treat-to-target (T2T) remission induction protocol in clinical care: (MTX, hydroxychloroquine (HCQ), i.m. glucocorticoids (GC), and, if not in remission, the TNFi golimumab (GOL)) (phase I, 3/4th or 1 year). Patients in sustained remission on MTX/GOL (DAS28<2.6 with max 4 swollen joints of the 44 swollen joint count (SJC) at 2 consecutive visits 3 months apart) will be randomized to taper either MTX first, then GOL or GOL first, then MTX with as primary endpoint sustained (drug free) remission (phase II, 1 year). During 1 year additional follow-up maintenance of drug-free sustained remission will be investigated (phase III). Study population: RA patients fulfilling 2010 American College of Rheumatology (ACR)/EUropean League Against Rheumatism (EULAR) criteria for RA, with symptom duration <12 months; naïve for anti-rheumatic drugs and glucocorticoids for RA; DAS28 ≥3.2. Intervention: Patients in sustained remission (defined as DAS28<2.6 with max 4 swollen joints of the 44SJC at ≥ 2 consecutive visits 3 months apart) on MTX/GOL at the end of phase I (after 24 weeks of treatment with MTX/GOL) will be randomized in a ratio of 1:1 to taper medication as follows: - Taper and stop GOL first during 24 weeks, then, if still in sustained remission, taper and stop MTX during 24 weeks - Taper and stop MTX first during 24 weeks, then, if still in sustained remission, taper and stop GOL during 24 weeks The primary end point is the proportion of patients in sustained remission at week 24 after start of tapering of either MTX or GOL first. The main secondary end point is the proportion of patients in drug-free sustained remission, at week 48 after start of tapering.
The aim of the study is to evaluate cardiovascular events during long-term follow-up in Rheumatoid Arthritis. The primary outcome "any cardiovascular event" will be evaluated using systematic audits of patient records, and will be associated to low levels of vitamin D at baseline, to investigate the hypothesis that low levels of vitamin D can be part of a prediction model for cardiovascular disease in Rheumatoid Arthritis.
RA (Rheuatoid arthritis) is a multisystem disease that mainly involves joints resulting in destructive arthritis if not treated rapidly. Inspite of various advances in field of early diagnosis and treatment of RA, there is still a need for better understanding of the efficacy and safety of various combinations of conventional DMARDS, and to rank them in order accordingly, so as to give a clearer vision for further management of RA once MTX monotherapy fails, so as to achieve remission as soon as possible. The study will be conducted at the Department of Clinical Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical Education & Research). patients who fail methotrexate monotherapy will be randomised to 2 treatment arms - either a combination of Sulfasalazine (SSZ), Hydroxychloroquine (HCQ) and Methotrexate (MTX) or Leflunomide (LEF), Hydroxychloroquine (HCQ) and Methotrexate (MTX)
Evaluate correlations between the validated 12 joints-Naredo ultrasound score (B-mode (0-3), PD (0-3) or PDUS (0-3, max between B-mode or PD)) and the DAS28-ESR, DAS28-CRP, CDAI, SDAI and ACR-EULAR criteria for remission in routine care.
RA is the most common inflammatory, persistent and progressive disease of the joints with serious co-morbidities and huge health and socio-economic impact worldwide.
Aim: To describe 1) The use of TNF blockers monotherapy in early arthritis in daily clinical practice in France 2) To evaluate symptomatic, structural efficacy, and retention rate over 5 years of TNF blockers monotherapy 3) To evaluate predictive factors for TNF blocker response monotherapy 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 ACR-EULAR 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 monotherapy: we will calculate the % of patients initiating TNF blockers monotherapy (Kaplan-Meier method), and we will describe the type of TNF blocker, the route of administration, the dosage, and the place of the TNF blockers monotherapy in the treatment strategy during the first 5 years. 2. Identification of potential predictive factors for initiation of TNF blockers monotherapy: a survival curve (Kaplan-Meier) will be performed. The baseline characteristics of the patients with regard to the initiation of TNF blocker monotherapy 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. 3. Therapeutical effect: we will calculate the retention rate over time, and will compare the changes in different variables in the group of patients who have received TNF blockers monotherapy matched (using a propensity score) to 1,2 or 3 patients who have received TNF blockers in combination with synthetic DMARDs. We will assess and compare DAS28 and HAQ at 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. We will identically estimate the drug effect depending on the TNF blocker used, by calculating the retention rate and comparing DAS28 at short term and long term. 4. Identification of predictive factors for TNF blocker monotherapy 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 use of TNF blocker monotherapy, its efficacy and retention rate, and on predictive factors for TNF blocker monotherapy response in early RA patients.
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.