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356 active trials for Rheumatoid Arthritis

Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor

Personalized medicine in which each patient would receive the ideal personalized treatment and regimen, holds great promise to improve patient's care. However, previous studies failed to establish validated predictors of response to disease-modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA). JAK inhibitors is a new class of DMARDs with great efficacy that might be even superior to anti-TNF drugs. As there are chemicals, their production cost is much cheaper than biological therapies and they will probably be central in patient's care in the coming years. Two are currently available: tofacitinib (TOFA) and baricitinib. Our study will focus on TOFA. Clinical outcomes mainly depend on i) factors influencing drug metabolism & concentrations and ii) adequacy between drug target and the inflammation pathways involved in the patient's disease. Humans carry in their gut trillions of germs, which are now known to be key players in health and disease. Those germs possess many enzymes and strongly modulate human enzymes expression. Gut-microbiota can, indeed, directly metabolize oral drugs and control the expression of the cytochrome P450 3A4 (CYP3A4), the main enzyme metabolizing TOFA. We showed, in a preliminary mouse experiment, that modifying gut-microbiota composition changes TOFA effects on signaling pathways. We thus believe that models including gut-microbiota composition together with markers of immune activation will predict clinical outcomes in RA patients treated with TOFA. Main and secondary objectives: To build predictive models for clinical outcomes (efficacy and safety) of RA patients treated with TOFA based on microbiota analysis and markers f immune activation. Methodolgy: This multicentric longitudinal prospective study will include 60 patients with RA and inadequate response to methotrexate. The clinical outcomes studied will be EULAR non-response at 3 months as defined by the European league against rheumatism EULAR (primary outcome), achievement of low-disease activity at 6 months or incident adverse events (secondary outcomes). Gut microbiota will be assessed at baseline and M3 from thawed fecal samples. DNA will be purified using QIAamp DNA stool mini kit (Qiagen) and qualify using Qubit and TapeStation 4200 (Agilent). Library will be prepared by amplification of V1-V2 and V3-V4 regions from the bacterial 16S rRNA genes and will be qualified by q-PCR and amplicons will be sequenced by MiSeq (Illumina). Initial bioinformatic analysis and taxonomies will be carried out using the QIIME2 software. Immune activation will be assessed through JAK-STAT pathway activation by JAK STAT signaling pathway RT² profiler PCR Array (Qiagen) which profiles expression of 84 genes related to Jak and Stat-mediated signaling. TOFA concentrations will be assessed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) at baseline and 3 months. Statistical classifiers (Neural network algorithm, Linear and Quadratic Discriminant Analysis, Support Vector Machine, Random forests, Shrinkage Methods, or Nearest Neighbors) incorporating microbiome, JAK STAT signaling pathway gene expression and clinical data, will be used to determine profiles associated with TOFA clinical response and safety. Patients who will prematurely stop TOFA (before 3 months) for adverse events or loss of follow-up will be considered as non-responders.

Start: October 2020

Outcomes Study of the TM Reverse Shoulder System Used in Primary or Revision Reverse Total Shoulder Arthroplasty

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.

Start: January 2011

Sidus(TM) Post Market Clinical Follow-up (PMCF) Study

This post market clinical follow-up study is designed to confirm safety and performance of the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty. The safety of the implant will be evaluated by monitoring the frequency and incidence of all kinds of adverse events. The performance will be determined by analyzing the implant survival, overall pain and functional performances (based on Constant & Murley score and ASES score), subject quality of life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component migration) of study subjects who received the Sidus Stem-Free Shoulder. The Sidus Stem-Free Shoulder is not approved for use in the US.

Start: October 2012

Persona Total Knee Arthroplasty Outcomes Study

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance.

Start: July 2014

Evaluation of the Condition of Rheumatoid Arthritis After Treatment

To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis patients

Start: May 2014

Prediction of Abatacept Discontinuation Using Test Reflecting Immunological Remission in Rheumatoid Arthritis

The objective of this study is to identify a panel of immunological molecular and cellular biomarkers able to predict the success of major dose-reduction or discontinuation of abatacept in rheumatoid arthritis patients

Start: June 2020

Usefulness of Non TNF Usage in RA Patients

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients: Sarilumab treatment for 12 months Tocilizmab treatment for 12 months Abatacept treatment for 12 months

Start: December 2018

Examination of Efficacy and Safety of Baricitinib in RA Patients

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients: Baricitinib treatment for 12 months Biologics treatment for 12 months Tofacitinib treatment for 12 months

Start: November 2018

Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics

This is a single site study to determine the structural efficacy of sarilumab when administered to biologic naive patients with active rheumatoid arthritis

Start: June 2018

Rheumatoid Arthritis Memory B Cells and Abatacept (RAMBA)

Single-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment with Intravenous Abatacept Adults with Rheumatoid Arthritis who are Naive to Biologic Disease-Modifying Antirheumatic Drugs

Start: June 2019

Zimmer POLAR - Total Knee Arthroplasty (TKA)

Start: October 2013

Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System

Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.

Start: October 2014

PMCF Study of the A.L.P.S. Proximal Humerus Plating System

This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S. Proximal Humerus Plating System applied in proximal humerus fracture treatment.

Start: June 2018

To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis

To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity.

Start: November 2018

Liver Fibrosis and Gut Microbiota in Patients With Psoriasis Vulgaris and Rheumatoid Arthritis on Methotrexate

While methotrexate (MTX) remains a treatment of choice for patients with rheumatoid arthritis (RA), psoriasis (PsO) and psoriatic arthritis (PsA), long-term MTX use has been shown to be associated with liver fibrosis and cirrhosis in these patients. In addition, gut dysbiosis has been found to be associated with liver fibrosis and cirrhosis via the gut-liver axis, underscoring the potential role of gut microbiota and bacterial translocation in the pathogenesis of chronic liver diseases in these patients. In this study, we aim to assess the prevalence of advanced liver fibrosis or cirrhosis among these patients on MTX treatment compared to those without, using transient elastography. We also aim to identify the possible risk factor(s) for advanced liver fibrosis or cirrhosis among them. Further, we aim to characterize the difference in fecal microbiota patterns among these three groups of patients. Using a cross-sectional, prospective cohort design, this study will enroll approximately 600 eligible patients, including 300 patients with PsO/PsA and 300 patients with RA, to examine the following hypotheses: Patients on higher cumulative dose of MTX will have higher prevalence of advanced liver fibrosis or cirrhosis compared to those on lower cumulative dose of MTX; Patients with MTX use will have higher prevalence of advanced liver fibrosis or cirrhosis compared to those without MTX use; The fecal microbiota composition will be different between patients with and without MTX treatment; and The fecal microbiota composition will be different between patients with and without advanced fibrosis/cirrhosis while on MTX treatment.

Start: August 2020

Association Between Subtypes of Anti Citrullinated Peptide Antibodies and Lung Damage in Rheumatoid Arthritis

Rheumatoid arthritis is a genuine systemic disease associated with diffuse interstitial pneumopathy and bronchial disorders. According to the literature review, the prevalence of PID on thoracic CT scan is one-third of patients. Diffuse interstitial pneumopathy is responsible for a significant morbidity and mortality, is currently under-diagnosed and its treatment is poorly codified. The lung seems to have a central role in the genesis of rheumatoid arthritis. It also appears that some subtypes of anti citrullinated peptide antibodies are preferentially present in the lungs. The hypothesis behind our project is that one or more subtypes of anti citrullinated peptide antibodies with a preferential tropism for the lung would attack the parenchyma and pulmonary airways. Currently, there are no data on interstitial pneumopathy in black and Afro-Caribbean subjects with rheumatoid arthritis.

Start: June 2016

Relationship of Periodontitis and Cardiovascular Risk in Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is one of the most common autoimmune inflammatory arthritis affecting 0.5 to 1% population worldwide characterized by synovitis, increased inflammatory markers and progressive bone and cartilage erosion. RA is associated with an increased cardiovascular morbidity and mortality compared with the general population.

Start: April 2019

Regulatory B Cells in Inflammatory Rheumatisms and Biomarkers of Response to Biologic Treatments

B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Bregs have also been identified in humans.

Start: July 2012

Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)

The VaricElla zosteR VaccinE (VERVE) trial evaluates the safety and effectiveness of the herpes zoster (shingles) vaccine, Zostavax, in patients over 50 years old with arthritis and other diseases who are using anti-TNF therapy and who have not previously received the vaccine.

Start: May 2016

Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction

This is an international (Sweden, Finland, Norway, Denmark, Iceland and the Netherlands) trial designed to compare the safety and efficacy of active conventional therapy (ACT) and three biologic treatments in subjects with early rheumatoid arthritis (RA). The global aim of this study is to assess and compare the proportion of subjects who achieve remission with ACT versus three different biologic therapies (Certolizumab-pegol, Abatacept or Tocilizumab) two alternative de-escalation strategies in patients who respond to first-line therapy.

Start: December 2012