The MyRA study will primarily investigate whether there are associations between the structure and function of the gut microbiome and response to methotrexate in early rheumatoid arthritis patients. The microbiome will be characterised via shotgun metagenomic sequencing of microbial DNA present in stool samples taken during the participant's first 6 months of taking methotrexate.
Methotrexate is often the first drug of choice for patients with early rheumatoid arthritis (RA), but its efficacy is highly variable and it can lead to severe side effects. There are currently no reliable predictors of methotrexate efficacy for people with early RA. Microbial dysbiosis (an imbalanced microbiome) has recently been implicated in RA, with associations between specific microbes and RA biomarkers or disease activity. Gut microbes have extensive capabilities in terms of xenobiotic (e.g. drug) metabolism. Several gut microbes are able to alter the drug methotrexate in vitro, and it is possible this could effect drug efficacy in vivo. Alternatively methotrexate efficacy could be affected by baseline microbial composition or alterations to microbial composition over the course of treatment.
Study Type
OBSERVATIONAL
Enrollment
30
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom
Change in DAS28-CRP score
Disease Activity Score using 28 joints and C-reactive Protein
Time frame: 0-6 months
Change in SDAI score
Simplified Disease Activity Index
Time frame: 0-6 months
Concentration of CRP in blood
C-reactive Protein (an inflammatory biomarker)
Time frame: 0-6 months
ESR value (blood)
Erythrocyte Sedimentation Rate (an inflammatory biomarker)
Time frame: 0-6 months
Concentration of anti-CCP in blood
Anti-Cyclic Citrullinated peptide (disease-specific antibody)
Time frame: 0-6 months
Concentration of RF in blood
Rheumatoid Factor (disease-specific antibody)
Time frame: 0-6 months
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