About the ETRO Studies

Stay Informed. Prepare for What’s Next.

Why are we engaging in this study?

We want to test new potential treatment options for people with moderately to severely active Ulcerative Colitis (UC) or Crohn’s disease whose current or past medications are not working well for them.

Clinical research studies help answer important questions about these potential new treatments.

What are the Etro Studies?

The Etro Studies will test whether the benefits are greater than the risks of an investigational injectable medication for people with moderately to severely active Crohn’s disease or UC.

What is the aim of the Etro Studies?

The goal of these studies is to look at the effect of the study medication in participants who still have symptoms of UC or Crohn’s disease despite previously being treated with corticosteroids, immunosuppressants, and/or tumor necrosis factor (TNF) inhibitors.

What medications will participants receive?

Etro Studies is a family of several different Phase III trials, all 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 may participants 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).

How long will my 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 be on the study drug for up to a number of years.

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 my 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 for a number of years under continued supervision by the study coordinators.

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.

Where will my study take place?

The Etro Studies will take place in over 40 countries around the world, including at multiple study centers across the US. To see if you might be eligible for a study near you, take the quiz.

How will the study medication be administered?

Study participants will receive study medication as a subcutaneous injection, which is a shallow, relatively painless injection similar to those used for flu shots or other vaccines. You may also be able to administer the study medication yourself (called self-administration) once you have been properly instructed by a doctor.
Do I have to do the entire study at the center where it’s being conducted?

For the first few injections, you’ll visit the study center so we can get you started in a monitored environment. Later on, for some of the studies, you or your caregiver may be trained on how to inject the medication at home (called self-administration). Participants may then be able to choose whether they want to participate exclusively at the study center or partly at home (but note that even participants who self-administer their medication will need to make occasional visits to the study center during the course of the study).

Can I do the injections at home?

For some of the studies, and if your doctor feels it is appropriate, you or your caregiver will be able to inject study medication at home. You will be given enough prefilled syringes of study medication to last until your next study center visit. If you don’t feel comfortable injecting at home, you have the option to do the entire study at the center.

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

 

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