FAQs

How can the clinical trial potentially help people with Crohn's Disease?

Many of the current available treatments for Crohn's Diesase are effective but in some patients cause side effects which are difficult to live with. Some treatments require patients to administer injections or to have infusions in hospital. It is hoped that if laquinimod proves to be safe and effective in people with Crohn's Diesase, then the choice to be able to take an oral drug may be more convenient for patients.

Importantly, participating in this clinical study may not only enable you to help yourself, but also future patients with Crohn's Diesase by contributing to medical knowledge about a potential new treatment option being studied.

Are there any risks associated with participating in this clinical trial?

As with any drug, there is a possibility that you may experience unpleasant or potentially serious side effects, some which may be unknown, while participating in this clinical study, or that the study drug or placebo may not be effective for you. However, the study team will review the potential risks and side effects with you, both before you agree to participate in the study and throughout the study at all of your visits.

What will happen if I decide to participate in this clinical trial?

Eligible participants will be asked to attend an initial screening appointment and an additional 7 clinic appointments at their designated study site over 14 weeks. During these appointments, the study doctor and nurse may ask you questions about your experience on the study drug, perform laboratory tests and/or conduct a physical examination. The appointments will also be an excellent opportunity to ask whatever questions you may have about the study or your experience as a participant.

In addition, you may find that study participation requires more time and attention than with your regular checks for your Crohn's Diesase management. We encourage you to ask questions and be sure you fully understand any potential risks or side effects and responsibilities before agreeing to participate.

As a study participant, you agree to take the study drug as directed during the treatment period, and attend all scheduled appointments as far as possible. Your commitment to these requirements is extremely important to the success of the study.

Will I be able to take other drugs for my Crohn's Disease whilst participating in this clinical trial?

If you are taking other drugs for the treatment of Crohn's disease which are allowed by the study protocol, you can continue to take them throughout the study. You should try not to change the dose of these drugs during the study or start a new treatment. If you do, you will need to tell your study doctor. There are certain drugs which you will not be allowed to take if you decide to participate in the trial and your study doctor will discuss this fully with you before you decide whether or not to participate in the trial.

What should I do if I am interested in participating in this clinical trial?

If you are interested in volunteering to participate in this study, or if you want to learn more, the first step is to consult your doctor to see if it may be right for you.

What if new information becomes available?

Sometimes we get new information about the drug being studied. If this happens, your study doctor will tell you about it and discuss with you whether or not you want to continue in the study. If you decide not to carry on, your study doctor will discuss alternative treatment options with you. If you decide to stay in the study, you will be given an updated information sheet and asked to sign a new consent form.

Who has reviewed the clinical trial protocol?

All clinical trial protocols are reviewed by a research ethics committee and the Regulatory Agency. The National Research Ethics Committee is an independent group of people, composed of for example, doctors, nurses and members of the public. This committee ensures that the rights of the participants will be respected, that any risks have been reduced to a minimum and balanced against possible benefits and that the study information to be given to the participant is clear and thorough. The research ethics committee must give all clinical trial protocols a favourable ethical opinion before they can go ahead.

For more information, please view http://www.nres.npsa.nhs.uk/patients-and-the-public/

Who has reviewed the scientific content of the clinical trial protocol?

In the UK, the government regulatory agency called the Medicines and Healthcare products Regulatory Agency (MHRA), is responsible for reviewing the clinical trial protocols. They ensure that the benefits of the proposed new clinical trial justify the risks to the participants. At the end of the clinical trial testing, once positive and conclusive results have been obtained, it is the responsibility of the MHRA to review all the results and conclude whether or not the new treatment/ drug gains a marketing application.

For more information, please view http://www.mhra.gov.uk/index.htm