A Clinical Trial to Compare Etrolizumab with Infliximab in Patients with Moderate to Severe Ulcerative Colitis Who Have not Received Treatment with Tumour Necrosis Factor Inhibitors (Gardenia)

How does the Gardenia clinical trial work?
This clinical trial is recruiting people who have ‘ulcerative colitis’, a condition that results in inflammation and ulcers in the back passage (‘rectum’), which may also extend to the large intestine or bowel (‘colon’). It is for people whose ulcerative colitis is categorised as moderately to severely active.

How do I take part in this clinical trial?
To be able to take part in this trial, you must not have already been given a type of medicine called a ‘tumour necrosis factor inhibitor’ for your ulcerative colitis.

If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor.

If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor who will give you all the information you need to make your decision about taking part in the clinical trial. You will also find the clinical trial locations at the top of this page.

You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests and procedures may be part of your regular medical care and may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial and what other treatments are available so that you may decide if you still want to take part. Both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or to take contraceptive medication while taking part in the trial for safety reasons.

What treatment will I be given if I join this clinical trial?
Everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and given one of two different treatments. This is a ‘placebo-controlled’ clinical trial, which means that patients will also be given a treatment with no active drug (also known as a placebo). You will have a 1 in 2 chance of being given each treatment.

• Either you will be given an injection of etrolizumab under the skin and a placebo given into your vein (called an ‘intravenous infusion’).
• Or you will be given infliximab into your vein and an injection under the skin of a placebo.

How often will I be seen in follow-up appointments, and for how long?
Etrolizumab or the placebo injection under the skin will be given once every 4 weeks during the 1 year long treatment part of the clinical trial. If appropriate, you may be able to administer the etrolizumab or placebo injection yourself at home after a period of training. Infliximab or the placebo infusion will be given at the clinical trial site once on Weeks 0, 2, and 6, and then every 8 weeks during the 1 year long treatment part of the clinical trial.

If you take part in this clinical trial, you will be asked to keep an electronic diary at home to record how you are feeling and managing with day-to-day tasks. You will need to go to the clinical trial site to assess your general health and how your body is responding to the treatment (and to be given the infusions). The clinical trial doctor will ask you about how your ulcerative colitis is responding to the treatment and about any side effects that you may be having.

If you withdraw from the trial because your symptoms of ulcerative colitis have got worse or for any other reason, you may be given the chance to take part in another clinical trial (COTTONWOOD) where you will be given long-term treatment with etrolizumab. The clinical trial doctor will give you all the information you need to make your decision about taking part in this other clinical trial.