About the study and the number of people involved
Taking part in the study involves firstly meeting with the research Doctor to find out more about your health and to see if the study is right for you. If you wish to take part and are eligible, we would like to see you for 12-19 clinic visits over approximately 52 weeks (1 year).
During visits, we conduct health checks that may include physical examinations and blood tests. We would like to ask you questions about your health and RA throughout the study.
Other procedures include: - Chest X-rays
- Vital signs
- ECGs
- Clinical laboratory testing (for example, pregnancy, serum FSH, tuberculosis, and serology)
- Subcutaneous injection of the study drug
- Premedication/post-medication before and after the study drug (oral and intravenous injection)
- 48-hour inpatient monitoring after each dose
- Daily calls after discharge
- Health questionnaires and assessments
- Optional Synovial biopsy (joint tissue sample) - conducted at screening, Week 12, and Week 48 for consenting participants
The study medication is administered as a subcutaneous injection (under the skin) into the upper arm, thigh, or abdomen. Each injection requires a 48-hour hospital stay for safety monitoring. Depending on the assigned dosing schedule, some participants will receive 1 injection, while others will receive up to 4 injections throughout the study. Medication will also be given before and after the study drug dosing to help limit potential side effects.
The study aims to investigate the investigational treatment and evaluate its effectiveness in reducing RA inflammation.
About the investigational medication
The investigational medication is a subcutaneous injection, meaning that it is injected under the skin. The medication is an engineered antibody protein designed to work with your immune system. In RA, certain immune cells called B cells become overactive and attack your joints. The study drug aims to work like a "molecular bridge" that:
- Connects your body's T cells (immune system defenders) to the problematic B cells
- Helps the T cells find and eliminate the B cells that are causing inflammation
- Reduce joint pain and swelling by removing these disease-causing B cells
Think of it as helping your immune system's "security guards" (T cells) identify and remove the "troublemakers" (B cells) that are damaging your joints.