All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

This research study is looking into a medication called Upadacitinib for a long-term bowel condition called ulcerative colitis. We want to understand how safe it is and how well it works over time. This study is specifically for people who have been part of previous Upadacitinib studies for ulcerative colitis. This includes individuals whose condition didn't improve enough, those who saw their symptoms return, or those who successfully finished a previous study. By continuing to follow these participants, we hope to gather important information about this treatment's ongoing effects.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AbbVie
Enrolment target
950
Start
31 Jan 2017
Estimated completion
01 Jul 2027

What is this study about?

This study is about a medicine called Upadacitinib, which is being investigated for a condition known as ulcerative colitis. Ulcerative colitis is a long-term health problem where the lining of your large intestine (colon) and rectum becomes inflamed and develops tiny open sores, called ulcers. This can cause symptoms like tummy pain, diarrhoea, and blood in your poo.

The main goal of this particular study is to see how safe Upadacitinib is over a longer period, and how well it continues to help people manage their ulcerative colitis. This is very important because it helps doctors and researchers understand if the benefits of the medicine last, and if there are any long-term side effects that aren't seen in shorter studies.

This study is specifically designed for people who have already taken part in other studies involving Upadacitinib for ulcerative colitis. This includes those who might not have gotten the full benefit from the medicine during an earlier phase, those whose symptoms came back after initially getting better, or those who successfully completed a previous study. By continuing to follow these groups of people, we can get a complete picture of the medicine's long-term impact.

Key takeaways

  • This study is about the long-term effects of Upadacitinib for ulcerative colitis.
  • It's for people who've previously taken part in related Upadacitinib studies.
  • The aim is to check its ongoing safety and how well it continues to work.
  • Regular health checks and tests will be part of taking part.
  • You can stop participating at any time if you change your mind.

Who may be eligible?

You might be able to join this study if you're between 16 and 75 years old and have been involved in a previous Upadacitinib study for ulcerative colitis. This includes if your symptoms didn't fully improve after the first part of that study, or if your symptoms returned after getting better. You could also be eligible if you successfully finished the previous Upadacitinib study.

To be considered, female participants must not be pregnant, trying to get pregnant, or breastfeeding, and they need to use effective contraception. Generally, you should also be in good overall health, as decided by the study doctor based on your previous medical checks from the earlier study.

You would not be able to join if the study doctor thinks you're not suitable for any reason, or if you've had a bad reaction to Upadacitinib or its ingredients in the past. People with active infections, including untreated tuberculosis, would also not be able to take part until the infection is successfully treated.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have you participated in a previous Upadacitinib study for ulcerative colitis?
  2. Are you between 16 and 75 years old?
  3. If female, are you not pregnant, trying to get pregnant, or breastfeeding, and willing to use contraception?
  4. Do you feel generally well, or have an infection that has been treated?
Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive either Upadacitinib or a placebo (a dummy medicine with no active drug) if you were in the previous study's maintenance phase, or only Upadacitinib if you successfully completed the full previous study. You'll have regular visits to the clinic where the study team will monitor your health, check for any side effects, and see how your ulcerative colitis is responding to the treatment. This will involve physical examinations, blood tests, and possibly other assessments like stool samples or questionnaires about your symptoms. The exact number and frequency of visits will be explained by the study team, but they are designed to closely monitor your health and the effects of the medicine over a longer period.

Potential risks and benefits

Taking part in this study may offer a potential benefit if Upadacitinib helps to control your ulcerative colitis symptoms in the long term, potentially improving your quality of life. However, as with any medicine, there are potential risks, including side effects from Upadacitinib. The study team will explain these risks in detail. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (492)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • East View Medical Research, LLC /ID# 171184
    Verified postcode
    Mobile, United States
  • CB Flock Research Corporation /ID# 165986
    Verified postcode
    Mobile, United States
  • Delsol Research Management, Ll /Id# 170130
    Verified postcode
    Chandler, United States
  • Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211886
    Verified postcode
    Mesa, United States
  • Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 169823
    Verified postcode
    Sun City, United States
  • Adobe Clinical Research LLC /ID# 155249
    Verified postcode
    Tucson, United States
  • Duplicate_University of Arizona /ID# 150568
    Verified postcode
    Tucson, United States
  • Citrus Valley Gastroenterology /ID# 151915
    Verified postcode
    Covina, United States
  • Newport Huntington Medical Group /ID# 217006
    Verified postcode
    Huntington Beach, United States
  • UC San Diego Health System /ID# 155187
    Verified postcode
    La Jolla, United States
  • United Medical Doctors /ID# 207467
    Verified postcode
    Los Alamitos, United States
  • TLC Clinical Research Inc /ID# 216830
    Verified postcode
    Los Angeles, United States

Common questions

What is Upadacitinib?

Upadacitinib is a medicine being studied for long-term conditions like ulcerative colitis. It works by calming down the immune system to reduce inflammation.

What is ulcerative colitis?

Ulcerative colitis is a condition where the large bowel (colon) and rectum become inflamed, leading to symptoms like tummy pain and diarrhoea.

Why is this study specifically for people who were in a previous study?

This study is like a follow-up. It helps us understand the long-term effects of Upadacitinib on people who have already started the treatment or finished an earlier phase of the studies.

Will I definitely receive the actual study drug, Upadacitinib?

If you are joining from a part of the previous study where you were receiving Upadacitinib, you will continue to receive it. If you were in a part of the previous study where you might have received a placebo, you may continue to receive either Upadacitinib or the placebo, depending on the study design.

How long will I be in the study?

This is a long-term study, but the specific duration for each participant will be explained by the study team. It will involve regular check-ups over an extended period.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.