About the ETRO Studies

3700 Patients. 40+ Countries.

If you still have symptoms of Ulcerative Colitis or Crohn’s even though you’ve received treatment for your condition, you may be eligible to participate in the Etro Studies. Our teams of professionals have worked tirelessly to make this enrollment phase of the study possible.

Here’s a quick overview of what the studies entail.

What are we trying to achieve?

The Etro Studies will test whether the benefits are greater than the risks of an investigational injectable medication for people with moderately to serverely active Crohn’s and Ulcerative Colitis (UC).

What is the aim of these studies?

The goal of these studies is to look at the effect of the study medication in individuals who still have symptoms of Crohn’s or UC despite previously being treated with corticosteroids, immunosuppressants, and/or tumor necrosis factor (TNF) inhibitors. Some studies will evaluate the study medication in participants who are anti-TNF naïve, and others in participants who have had an inadequate response, loss of response, or intolerance to anti-TNF therapy.

How do the Etro Studies work?

The Etro Studies are designed to explore how well the study medication works, and how safe it is, in comparison with other medications or a placebo.

Study participants are placed into different groups, depending on the design and needs of that particular study. Some participants may receive the study medication, others may receive an existing therapy option, and some participants may receive a placebo (which looks the same as the study medication but contains no active medication).

Parts of this study are double-blinded, which means that neither you nor your study doctor will know whether you are taking the study medication or the comparator medication (which would be either an existing therapy or placebo). In the open-label study, all eligible patients (including those who were given placebo during earlier phases) can receive the study drug.

How long will the study last?

Etro Studies comprises several different trials, and each trial has its own duration period. The length of your participation will depend upon which study you participate in.

The longest trial in the Etro Studies family, for example, could last up to 82 weeks (1 ½ years) and will involve regular study center visits and telephone calls. If you become a trial participant and are considered eligible for the open-label extension, you could possibly remain on the study drug until it becomes commercially available.

It is important to know, however, that study participants may withdraw themselves from a trial at any time. This will be without penalty or loss of medical benefits you had prior to participating in the study. Tell the study doctor if you are thinking about stopping or decide to stop. The study doctor will tell you how to stop safely.

What happens when the study is over?

At the end of your participation in the study, you may be eligible to receive the study medication as part of a separate extension study, called an “open-label extension.” This period even includes free study drug—under continued supervision by the study coordinators—until the drug becomes commercially available.

If you decide to stop taking the study medication, you will enter a 12-week follow-up period. We will also ask if we can contact you by telephone every 6 months, for up to 2 years, for additional safety monitoring as part of a separate study.

What makes the Etro Studies different?

The Etro Studies family of Phase III clinical trials include the first clinical trials (planned for review and approval) in the Ulcerative Colitis disease area to compare a study medication to already approved medications. The Etro Study in Crohn’s disease will be the first key study to test not only whether a patient is feeling better, but also whether their underlying disease is improving.

In addition, the Etro Studies clinical program includes open-label extension studies, which may grant eligible participants access to free study medication for an additional period of time once their participation in the trial is over, even though the study medication may not yet be approved for use.

Why Participate in a Clinical Trial?

  • You may get expert medical care from leading specialists and nurses throughout the study
  • You’ll receive medication for up to 7 years, at no cost, if you are eligible and choose to participate in the open-label extension
  • You remain in control of your level of participation
  • You contribute to scientific understanding of Ulcerative Colitis and Crohn’s disease

Interested in taking part in the Etro Studies? Find out if the Etro Studies could be right for you.

 

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