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Arthritis, Rheumatoid clinical trials

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NCT ID: NCT02547493 Completed - Clinical trials for Rheumatoid Arthritis

Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients

VACINA
Start date: March 3, 2016
Phase: N/A
Study type: Interventional

Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral response) in RA patients treated with abatacept, biotherapy targeting T-cells? The investigator propose to conduct a prospective, multicenter (11 centers), randomized, open-label study. The patients are going to be randomized in 2 groups: patients of the first group will be vaccinated with the polysaccharide pneumococcal vaccine (Pneumo23®/Pneumovax®) whereas patients of the second group will be vaccinated with conjugate pneumococcal vaccine (Prevenar13®).

NCT ID: NCT02544334 Completed - Clinical trials for Rheumatoid Arthritis

Oral Metagenomic Biomarkers in Rheumatoid Arthritis

Start date: May 2016
Phase:
Study type: Observational

Rheumatoid Arthritis (RA) is a chronic and potentially severe autoimmune disease affecting 2 million in the United States. The role of environmental factors in modulating autoimmunity pathogenesis has been clearly described and yet the specific mechanisms of action remain poorly understood. A growing body of evidence implicates microbiota of mucosal surfaces in the development of autoimmune disorders. Various studies have clearly linked RA to periodontal disease. The latter is linked to the red-complex that includes the oral bacterium Porphyromonas gingivalis. And yet there has not been a systematic analysis of the oral microbiota in RA to determine whether there are specific markers for P. gingivalis (and other oral bacteria) that are linked to RA. In this study, the investigators will characterize oral microbial composition (microbiome) and gene content (metagenome) of DNA isolated from oral samples obtained from patients with (i) early stage RA prior to biologics treatments and (ii) subsets of RA patients who are responsive or unresponsive to anti-TNF-alpha therapy. The innovative aspect of this study is going beyond the identification of oral bacterial species, to the level of strains and genes that are associated with these groups. The overall hypothesis is that oral microbial variation exists between individuals that influences development of autoimmunity and autoimmune disease.

NCT ID: NCT02535832 Completed - Clinical trials for Rheumatoid Arthritis

Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)

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

Muscle strength helps determine a person's quality of life and functional independence. Patients with rheumatoid arthritis often suffer from muscle weakness and a pre-diabetic condition called insulin resistance. By doing this study, the investigators hope to learn why patients with rheumatoid arthritis (RA) suffer from muscle weakness.

NCT ID: NCT02534311 Completed - Clinical trials for Rheumatoid Arthritis

A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28)

Start date: October 13, 2015
Phase: N/A
Study type: Observational

The purpose of this clinical trial is to prospectively evaluate RA activity using the assessment of change in DAS28 under local conditions in Slovakia in participants who are treated with subcutaneously administered tocilizumab pursuant to the recommendations of the Ministry of Health of the Slovak Republic in order to better assess the disease activity and impairment of the joint function.

NCT ID: NCT02531178 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis

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

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of different dose levels of ABBV-257 given with methotrexate. ABBV-257 or placebo will be administered once every other week (EOW) for a total of 4 doses. Subjects will continue on their stable dose of methotrexate weekly throughout participation in the study. This study will be conducted in approximately 24 subjects in 3 dose groups, with 8 subjects per group. Within each group, 6 subjects will be randomized to receive ABBV-257 and 2 subjects will receive placebo. Subjects participating in one dose group will be ineligible to participate in another dose group in the study.

NCT ID: NCT02531061 Completed - Clinical trials for Rheumatoid Arthritis

Impact of the Persistence of Inflammation at Doppler Ultrasound Level on the Structural Evolution of Erosion in Rheumatoid Arthritis Treated With Biotherapy

Start date: May 5, 2013
Phase: N/A
Study type: Interventional

Since biological disease-modifying anti-rheumatic drugs (bDMARDs) are available in rheumatoid arthritis (RA) strategy an emerging question is the definition of remission in RA. Today some criteria were already proposed and the last one was proposed in 2011. All these criteria integrated only clinical criteria without imaging assessment. In this context, ultrasound joint is daily performed without definition of remission. A discrepancy exists between clinical remission and persistence of active disease with ultrasound joint presence of a Doppler effect indicating inflammation and the risk of progression of joint damage. A definition of remission in RA could include erosions regression in subchondral bone (at best measured by high resolution peripheral quantitative computed tomography (HR-pQCT)). The main hypothesis is that the reduction of erosion size assessed by HR-pQCT will be observed only in the absence of local inflammation measured by Doppler ultrasound in the erosion. Tumor Necrosis Factor (TNF) blockers have strongly improved RA therapy outcome in terms of clinical improvement and structural damage (progression of radiographic lesions). Recent data showed that there could be joint bone rebuilt in case of inflammation suppression. HR-pQCT is a new technique emerging for bone erosions assessment in RA. Erosions size and volume could be reduced with anti-TNF, but with a large interindividual variability. There was no correlation between the activity of clinical or ultrasound synovium and evolution of erosion HR-pQCT.

NCT ID: NCT02528786 Completed - Clinical trials for Rheumatoid Arthritis

Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study

Start date: November 19, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to obtain blood samples from up to 14 participants who previously received namilumab in the previous study M1-1188-002-EM (PRIORA, [NCT01317797]) to correlate genetic markers with clinical outcomes.

NCT ID: NCT02528344 Completed - Clinical trials for Rheumatoid Arthritis

High Intensity Interval Training and Rheumatoid Arthritis

Start date: September 2015
Phase: N/A
Study type: Interventional

The overall objective is to determine whether High Intensity Interval Training (HIIT) has potential to improve disease activity scores for Rheumatoid Arthritis (RA) patients. By reducing inflammation and modifying immune function HIIT may offer a substantial paradigm shift in RA care, especially in older persons with RA who experience aging related-immunesenescence, increased systemic inflammation and greater physical inactivity than young persons. Prior to embarking on a large scale trial of HIIT-induced disease modification, this pilot study aims to demonstrate that HIIT can produce measurable responses in disease activity scores and peak VO2in persons undergoing routine pharmacologic treatment for RA.

NCT ID: NCT02522052 Completed - Clinical trials for Rheumatoid Arthritis

Mussels, Inflammation and Rheumatoid Arthritis (MIRA)

MIRA
Start date: August 2015
Phase: N/A
Study type: Interventional

Rheumatoid arthritis (RA) is a chronic disease that affects ~1% of the population. A large proportion of patients with established disease have persistent high disease activity in spite of existing effective pharmacological treatment. Improved treatment is thus urgently needed, including alternative treatments in addition to optimal pharmacological therapy. The main purpose of this study is to investigate if a high intake of blue mussel (Mytilus Edulis) could decrease inflammation and disease activity in patients with established RA. A secondary goal is to identify novel biomarkers for blue mussel intake and metabolic responses to this diet, using a metabolomics approach with high sensitivity and specificity. A third goal is to look at genetic polymorphisms in relation to long chain polyunsaturated fatty acids (LCPUFA) and inflammatory markers.

NCT ID: NCT02519387 Completed - Clinical trials for Rheumatoid Arthritis

Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity

Start date: July 2013
Phase: Phase 4
Study type: Interventional

This is a phase IV, open-label and single-arm study of patients with non-malignant pain due to osteoarthritis, rheumatoid arthritis, low back pain and joint/muscle pain, who were not responding to non-opioid analgesics. The primary objective was to assess the efficacy of buprenorphine transdermal patch for pain control among these patients.