This phase 3 trial will investigate the safety and effectiveness of switching from rituximab (Rituxan/Mabthera) to DRL_RI in patients with rheumatoid arthritis (RA).
The main outcome will be the rate of side effects and anti-drug drug antibodies (ADAs). This study is recruiting at several locations in the United States.
The details
Rheumatoid arthritis (RA) is a chronic immune condition. It is caused by painful inflammation in the joints. RA is treated with drugs to reduce inflammation. Rituximab (RTX) is a biologic drug. It binds to a protein called CD20. This reduces inflammation in RA. RTX is also known as Rituxan® in the US. It is called Mabthera® in the EU. DRL_RI is a biosimilar of RTX. A biosimilar is a generic version of the original drug. It is unclear if it is safe to switch from RTX to DRL-RI.
This trial will investigate the safety of switching from RTX to DRL_RI in patients with RA. The main outcome will be the rate of side effects and ADAs.
Who are they looking for?
This study will recruit 140 patients with RA. Participants must have been previously treated with RTX. They must also be taking a stable dose of methotrexate (MTX) and folic acid.
Patients cannot take part if they have active infections. Patients that are positive for HIV, hepatitis B, and/or C are excluded from the trial. Other exclusion criteria are uncontrolled medical conditions, weakened immune system and treatment with other biological drugs.
How will it work
Participants will be randomly assigned to one of the 2 treatment groups. One group will receive 2 infusions of DRL_RI. The other group will receive 2 infusions of RTX. This will be done on days 1 and 15. Patients will be assessed before treatment and at regular intervals. The last assessment will be 12 weeks after the first dose.
The main outcome will be the rate of side effects and ADAs.
