PROMOTE (Studying the effects of methotrexate on inflammatory biomarkers in knee osteoarthritis: can we predict response?)
Currently we do not have any drugs which slow down or stop osteoarthritis. We also need better treatments to manage pain associated with osteoarthritis. The Pain reduction with oral methotrexate in knee osteoarthritis, a pragmatic phase iii trial of treatment effectiveness (PROMOTE) clinical trial, funded by Versus Arthritis, previously studied whether the tablet drug methotrexate (a strong anti-inflammatory drug which is already used in other forms of inflammatory arthritis) could reduce knee pain in osteoarthritis.
The trial showed a small benefit on knee pain in those taking the active drug compared to those given a placebo (dummy drug). Some participants had their blood taken at the start of the study (before the drug was administered) and at the end of the study (after taking the drug for 6 months) for research purposes. This study sets out to test whether we can identify those people more likely to make a good response to this drug, by testing whether the individuals with greater levels of inflammation in their blood at baseline, or those with bigger changes in levels of inflammation in the blood over the course of the study make a better response to the drug than those who do not have these changes. This is particularly important, given the modest benefits of the drug overall. It will also help us to understand further the role of inflammation in osteoarthritis.
Aims and Objectives:
- We will use sophisticated laboratory testing to measure 36 different markers in each participant’s single blood sample, comparing their blood levels at the start and end of the study.
- We will show levels of these markers at the start and end of the study for those on active drug and those on placebo medication and look for differences between the two arms in the overall change in each of these markers.
- We will look at ‘responders’ to the medication (those whose knee pain improved substantially in the active arm of the trial) and study if they had higher levels of certain markers at the start of the study, or make a greater change in any of these markers compared with those who are ‘non responders’ (those whose pain did not improve).
||Early Disease and Risk Prediction: Prevent
|| 3.2ii, 3.2iii, 3.2iv
||Fiona Watt, Jennifer Alderson, Philip Conaghan, Sarah Kingsbury
||University of Oxford/ University of Leeds