This phase 2 trial will investigate the safety and effectiveness of ATI-450 in patients with rheumatoid arthritis (RA). The main outcomes will be the number of side effects and the change in disease activity (DA). This trial is recruiting at several locations in the United States.
The details
Rheumatoid arthritis (RA) is a condition caused by inflammation. This leads to painful swelling in the joints. Tissue degeneration occurs over time. RA patients take medication to reduce inflammation. Methotrexate (MTX; Otrexup) is one drug commonly used in RA. It is used alone or in combination with other drugs.
ATI-450 is an experimental RA drug. It targets an enzyme called MK2. This enzyme is involved in cell signaling pathways that promote inflammation. MK2 inhibitors can reduce inflammation. It is unclear if ATI-450 is safe and effective in RA in combination with MTX.
This trial will investigate the safety of ATI-450 in patients with RA. The main outcome will be the number of side effects and a change in DA.
Who are they looking for?
This trial will recruit 25 patients with RA. Participants must have moderate to severe RA and a C-reactive protein (CRP; a marker of inflammation) of 5 mg/L or higher. They must also be taking a stable dose of MTX before the trial.
Patients with other immune-related diseases cannot take part in the trial. Patients with a history of active tuberculosis, as well as other infections requiring antibiotics, are excluded. Other exclusion criteria are unstable doses of corticosteroid or non-steroidal anti-inflammatory drugs (NSAIDs). Patients with a history of stroke or recent joint procedures are also excluded.
How will it work
There will be 2 groups in this study. Patients will be randomly assigned to ATI-450 or placebo (inactive drug). This will be taken orally twice a day. All patients will also take a dose of MTX weekly. Treatment will last up to 114 days.
The main outcomes will be the number of side effects, a change in CRP levels, and DA.
