The aim of this phase 2 clinical trial is to measure the safety and effectiveness of the new drug RO7123520 in patients with moderate to severe rheumatoid arthritis (RA) who have not responded to tumour necrosis factor inhibitors (TNFIs). The main outcomes to be investigated are improvement in disease activity and bone density as well as safety of the drug.
The details
Methotrexate is a disease-modifying anti-rheumatic dug (DMARD). It is the most common first-line of treatment for RA. However, methotrexate is not effective in all patients and biological drugs such as TNFIs (such as etanercept [Enbrel]) may be prescribed instead. If neither of these treatments are improving a patient’s condition additional treatment may be required. RO7123520 has been recently developed for patients not responding well to standard therapy.
The current study will examine the effectiveness of RO7123520 in patients with moderate to severe RA who have not responded well to previous treatment. The main outcomes to be measured are improvements in health and disease activity and record any treatment-related side effects.
Who are they looking for?
This study will recruit about 204 patients with moderate to severe rheumatoid arthritis with at least 4 tender and 4 swollen joints. For the second part of the trial patients must have active synovitis (inflammation of the synovial membranes). Any ongoing TNFI therapy, steroid drugs, and non-steroidal anti-inflammatory drugs must be at a stable dose.
Patients must not have been exposed to any non-TNFI therapy for RA. Patients must discontinue non-oral steroid drugs for at least 6 weeks before the study. Patients must not have an autoimmune disease. Participants with recurrent viral, bacterial, or fungal infections, abnormal liver function, severe nervous system disease, or congenital or acquired immunodeficiency are not eligible. Patients should not have been treated for myocardial infarction in the 6 months prior to the study.
How will it work
The study will be split into 3 parts. During the trial, patients will continue to receive their normal dose of TNFIs and methotrexate. Patients will randomly be assigned to receive either RO7123520 or a placebo (control drug with no active effect on the body). Part 1 will evaluate the safety of the drug. Part 2 will evaluate the safety and effectiveness of the drug. Part 3 will evaluate the most effective dose.
Changes in disease, health assessments, and tolerance will be measured at week 12. Any side effects experienced will be recorded.
