This phase 3 trial will investigate the effectiveness of GSK3196165 combined with methotrexate (MTX).
The main outcome will be the number of patients achieving a 20% improvement in symptoms (ACR20).
The details
Rheumatoid arthritis (RA) is a condition caused by inflammation. Drugs that reduce inflammation are used to treat RA. Over time, the effectiveness of RA drugs can be reduced. New drugs are in development to target specific inflammatory targets. One target is granulocyte-macrophage colony-stimulating factor (GM-CSF). High levels of GM-CSF can lead to excessive inflammation. Targeting GM-CSF may reduce inflammation in RA. GSK3196165 is an experimental drug that binds to GM-CSF in the blood.
This trial will investigate the effectiveness of GSK3196165. The main outcome will be the number of patients achieving ACR20.
This trial is recruiting in San Marcos, Texas.
Who are they looking for?
This study will recruit 1500 patients with active RA. Patients must have an inadequate response to methotrexate (MTX, a standard RA drug). Patients must have at least one erosion on the hand or foot on radiographs.
Patients cannot take part in the trial if they have any active or recurrent infections. Prior treatment with anti-GM-CSF drugs is also excluded. If patients previously could not tolerate biologic drugs (e.g. tofacitinib, Xeljanz), they will not be able to take part in the trial.
How will it work
Patients will be assigned to one of 6 groups. All patients will be treated with up to 4 drugs or their placebo (inactive drug). These drugs include GSK3196165, MTX, tofacitinib, and folic acid. GSK3196165 will be administered via subcutaneous injection. The other drugs will be taken orally. Treatment will last up to 52 weeks.
The main outcome will be the number of patients achieving ACR20 at week 12.
