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Arthritis, Rheumatoid clinical trials

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NCT ID: NCT02485483 Completed - Clinical trials for Rheumatoid Arthritis

Validation of Standardized Questionnaires on Depression for Rheumatoid Arthritis (RA) (VADERA I) and Investigation of the Frequency of Depression in RA (VADERA II)

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

The purpose of this study is to validate standardized questionnaires on depression for rheumatoid arthritis (RA) and to investigate the frequency of depression with RA. The study will include 2 parts, VADERA I and VADERA II. In VADERA I, 300 participants will be surveyed twice at an interval of 3 months regarding their current emotional condition using standardised questionnaires. On the basis of the results of VADERA I, in VADERA II, the selected questionnaire will be used to assess the prevalence of depression with RA in approximately 1000 participants.

NCT ID: NCT02480946 Completed - Clinical trials for Arthritis, Rheumatoid

Safety and Tolerability Study of MBS2320 in Healthy Subjects and Subjects With Rheumatoid Arthritis

Start date: July 2015
Phase: Phase 1
Study type: Interventional

Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly inhibit bone damage.The aim of this study is to test the safety of MBS2320 in healthy volunteers, to find out how MBS2320 levels change in the blood with dose, and to test the safety and compatibility of giving MBS2320 to patients with RA in combination with an existing treatment, methotrexate.

NCT ID: NCT02480153 Completed - Clinical trials for Rheumatoid Arthritis

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Start date: June 25, 2015
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate. In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.

NCT ID: NCT02476084 Completed - Clinical trials for Rheumatoid Arthritis

Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients

BMUS
Start date: October 13, 2014
Phase:
Study type: Observational

The purpose of this study is to determine the kinetics of change in quantitative measures of joint inflammation by state of the art power Doppler vascular imaging and to identify biomarkers in biological samples (synovial biopsies, DNA, RNA, PBMC, serum, plasma, urine and stool samples) from parallel cohorts of RA patients undergoing different treatments. This will be achieved implementing MSUS assessments, standard laboratories techniques (such as ELISAs, gene profiling, transcriptome analysis etc.) and the novel CyTOF™ technology.

NCT ID: NCT02475486 Completed - Clinical trials for Rheumatoid Arthritis

Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF

ANSRA
Start date: February 25, 2016
Phase: N/A
Study type: Interventional

Despite the large therapeutic arsenal available since one decade allowing a strong reduction of inflammation process, rheumatoid arthritis (RA) patients claimed pain, fatigue, sleep problems and other quality of life outcomes. Fatigue reduction during TNF blockers therapy is lower than the strong reduction in RA disease activity. Furthermore, RA patients have higher prevalence of non-inflammatory pain than general population. Fatigue is a real major problem due to 50% of patients considered it as severe. This dissociation between disease activity and fatigue level suggests that fatigue is multifactorial. No consistent explanations for fatigue are currently available.

NCT ID: NCT02468986 Completed - Clinical trials for Rheumatoid Arthritis

Study of Venous Endothelial Cells in Rheumatoid Arthritis

Start date: August 2011
Phase:
Study type: Observational

Heart disease is the major contributor of early death in rheumatoid arthritis (RA) and is not influenced by traditional risk factors. Blood vessel dysfunction has been associated with heart disease and complications such as heart attack. The vessel dysfunction is thought to be mediated in part to inflammation. RA patients have evidence of vessel dysfunction seen on ultrasound that improves after medications are given. The purpose of this study is to evaluate patients with controlled or uncontrolled rheumatoid arthritis to determine if there is a difference in the protein expression in the cells that line the blood vessels compared to healthy people.

NCT ID: NCT02468791 Completed - Clinical trials for Rheumatoid Arthritis

MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and the reference product - MabThera® (rituximab) and to demonstrate comparative safety and tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with moderate to severe active rheumatoid arthritis.

NCT ID: NCT02467504 Completed - Clinical trials for Rheumatoid Arthritis

Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis

Start date: July 1, 2015
Phase: Phase 2
Study type: Interventional

Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease, characterized by symmetric poly-arthritis usually involving the small joints of the hands and feet. In addition, various extra-joint manifestations may develop. Several immunomodulating agents have been attempted in the treatment of RA without achieving satisfactory results. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active RA patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in RA. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in RA. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for RA by randomized controlled study (hrIL-2 (N = 23) + Methotrexate (MTX)+ Loxoprofen versus placebo+MTX + Loxoprofen group (N = 24)).

NCT ID: NCT02467205 Completed - Clinical trials for Rheumatoid Arthritis

Walk for Rheumatoid Arthritis (WARA Study)

Start date: November 2014
Phase: N/A
Study type: Interventional

The overall aim of this randomized control trial study is to investigate the effectiveness of a six-month, community based, pedometer supported, walking programme, along with an education programme incorporating behavioural change techniques on steps count and sedentary time, disease activity, functional capacity and cardiovascular risk of people within the first five years of being diagnosed with RA.

NCT ID: NCT02460393 Completed - Clinical trials for Rheumatoid Arthritis

A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects

Start date: May 2015
Phase: Phase 1
Study type: Interventional

This study is a randomized, double-blind and placebo-controlled trial with healthy subjects. There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12 people. A single subcutaneous injection will be administrated starting from the low dose group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously). Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects will be evaluated.