Clinical Research Details

Clinical Research

A Phase 3, multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

Study Description

This research study is being done to learn more about how well an investigational study drug, called otilimab, works and how safe it is when taken for a longer period in people with rheumatoid arthritis (RA).   Otilimab (also known as GSK3196165) is a study drug that is an antibody therapy and is given as an injection. Antibodies produced by our bodies are proteins that fight against intruders. Antibody medications, such as otilimab, are made in the laboratory and look like antibodies made by your body, except they specifically block certain substances. Otilimab blocks a specific chemical messenger called granulocyte-macrophage colony-stimulating factor (GM-CSF). Higher levels of GM-CSF are found in the joints of people with RA. It is thought that blocking GM-CSF will reduce symptoms and slow progression of RA.   This is a long-term extension study of up to about 4 years for people with RA who may benefit from extended treatment with otilimab, after completing the treatment period from a previous otilimab clinical research study, including:

 

–contRAst-1 (201790) –contRAst-2 (201791) –contRAst-3 (202018) This extension study is intended to provide otilimab to people with RA who may continue to benefit from treatment and until it is expected to become available as an approved drug. The main aim of this study is to provide long-term information on the safety of 2 different doses of otilimab. From this long-term extension study, we would like to answer the following questions: –What are the long-term side effects of otilimab? –How well does otilimab work over a long period of time in combination with other medications you are already taking for RA? –What effects does otilimab have in people with RA on their ability to function in everyday life, pain levels, overall health, and tiredness? –How does the body’s defense system (immune system) react to otilimab?

 

This is a Phase 3 study. This means that the study drug has already been tested in healthy volunteers and people with RA (such as the contRAst-1, contRAst-2, contRAst-3 studies and previously completed studies). It has also been tested in people with other conditions to see how safe it is and whether it might work. Before contRAst-1, contRAst-2, and contRAst-3, a total of 447 people had received otilimab.

Open Enrollment

Contact Name: Shannon Lloyd
Contact Phone: (904) 633-0071
Contact Email: shannon.lloyd@jax.ufl.edu

Investigators


Principal Investigator
Gurjit S. Kaeley, M.D.
Medicine