This phase 2 trial will investigate the safety and effectiveness of evobrutinib, a new treatment for rheumatoid arthritis. The main outcome will be the level of improvement in disease symptoms.
The details
Rheumatoid arthritis (RA) is a chronic condition caused by painful swelling and inflammation in the joints. Patients are prescribed medications to reduce inflammation, called disease-modifying anti-rheumatic agents or DMARDs. Methotrexate (MTX) is an example of a DMARD that is routinely prescribed to RA patients.
As RA is a chronic (long-term) condition it is important that treatments are safe and effective. Evobrutinib is a drug that reduces inflammation by blocking an enzyme called Bruton’s tyrosine kinase (BTK) and the activation on immune cells. It may reduced disease symptoms in patients with RA that do not respond to other DMARDs such as MTX.
This phase 2 trial will investigate the safety and effectiveness of evobrutinib. The main outcome will be a 20% improvement in disease symptoms.
Who are they looking for?
This trial will recruit 360 patients with active to severe RA. Patients must have been treated with MTX (7.5 mg to 25 mg/week) for at least 16 weeks prior to the trial. High sensitivity c-reactive protein (hs-CRP) level must be at least 5 mg/L.
Patients cannot take part in the trial if they are taking a number of medications including biological DMARDs, Janus kinase inhibitors and other BTK inhibitors.
How will it work
Patients will be randomly assigned to one of four groups. All groups will receive stable MTX therapy, in addition to placebo (inactive drug), or a low, mid, or high dose of evobrutinib. This trial will last 12 weeks.
The main outcome will be an improvement in disease symptoms as measured by hs-CRP levels and by an improvement in 20% of affected joints.
