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Rimu Rheumatoid Arthritis (RA) Study

Auckland

We are looking for people aged 18 or older with moderate to severe rheumatoid arthritis (RA) to join the Rimu Study. This is a phase 1B trial investigating an antibody treatment for RA. The treatment aims to target and eliminate cells associated with RA inflammation.

The main purpose of this study is to learn about the study medication and evaluate its safety and effectiveness in treating RA inflammation. The study will also assess how the drug affects disease activity, immune markers, and quality of life.

Description

What to expect

Study details

Ages

18 years or older

Duration

12-19 clinic visits over 1 year

Compensation

You will be reimbursed for your time and travel costs

Eligibility Criteria

  • 18+ with moderate to severe RA
  • Have tried csDMARDS (immunosuppressive medications) with no success
  • Have at least 4 tender joints and swollen joints

Locations

Auckland

Description

About the condition
Rheumatoid arthritis affects an estimated 40,000 New Zealanders. It is an ongoing, chronic condition that causes pain, swelling, and joint inflammation. But it can also damage other parts of the body. These may include the skin, eyes, lungs, heart and blood vessels.

Rheumatoid arthritis occurs when the immune system mistakenly attacks the body's own tissues. This is called an autoimmune condition. Rheumatoid arthritis differs from the more common osteoarthritis. Some people have both. Osteoarthritis causes joint damage from overuse. Rheumatoid arthritis affects the lining of the joints and can eat away at the bone beneath them. This causes painful swelling that can bend joints out of shape over time, leading to deformity.
The inflammation of rheumatoid arthritis can also damage other parts of the body. New medicines have greatly improved treatment choices. But rheumatoid arthritis can still cause long-term damage and increase the risk of heart disease.
Reason to participate
  • Your involvement in this study will help advance scientific knowledge that could contribute to the development of this investigational medication and a better treatment for people with RA in the future. Other reasons to participate include:  
  • Access to an investigational treatment approach that aims to target B cells more effectively than current therapies
  • Study-related monitoring and care by experienced healthcare professionals
  • All study-related care is provided at no cost  
  • Participants are reimbursed for their time and travel  

What to expect

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. 

Apply now

Fill out your details, and our team will be in touch to discuss your potential involvement in this study and answer any questions you may have.

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