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Active not recruitingPHASE3INTERVENTIONAL

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

This research study is for adults with Crohn's disease who have previously taken part in other specific studies (M14-431 or M14-433) involving a new medicine called upadacitinib. The main goal of this study is to continue looking at how effective and safe upadacitinib is when taken for a longer period. Upadacitinib is a tablet designed to help control Crohn's disease. Some participants will continue to receive upadacitinib, while others might receive a placebo (a dummy pill with no medicine). This is a Phase 3 study, meaning it's one of the final steps before a medicine might become widely available. The study hopes to provide further information to help doctors and patients manage Crohn's disease better.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AbbVie
Enrolment target
747
Start
21 Mar 2018
Estimated completion
01 Sep 2027

What is this study about?

This study is focusing on a specific medicine called upadacitinib, which is being tested as a treatment for Crohn's disease. Crohn's disease is a long-term condition that causes inflammation in the digestive system. Upadacitinib is taken as a tablet and works by targeting certain signals in the body that cause inflammation. Doctors are hoping this medicine can help manage the symptoms and effects of Crohn's disease more effectively.

This particular study is designed for adults who have already participated in earlier studies (M14-431 or M14-433) where they started treatment with upadacitinib. It's important to understand how well a new medicine works and if it's safe not just in the short term, but also over a longer period. By following participants for an extended time, researchers can gather more information about the medicine's lasting benefits and any potential side effects.

Understanding how medicines like upadacitinib work over time is crucial for developing better treatments for conditions like Crohn's disease. The information from studies like this helps doctors make informed decisions about prescribing medicines, and it supports better health outcomes for people living with Crohn's. The goal is to provide more options and improve the quality of life for patients.

Key takeaways

  • This study is for people already in specific Crohn's disease trials.
  • It aims to check long-term safety and effectiveness of upadacitinib.
  • Upadacitinib is a tablet being tested for Crohn's disease.
  • Some participants will receive upadacitinib, others a placebo.
  • Regular health checks and follow-up are part of taking part.

Who may be eligible?

This study is specifically designed for adults aged 18 to 75 who have Crohn's disease and have already taken part in one of two previous studies (M14-431 or M14-433) for upadacitinib. To join this current study, you must have shown a positive response to the treatment in those earlier studies. You'll also need to have completed all the procedures and visits required in those original studies, though some allowances were made for endoscopy appointments missed due to the COVID-19 pandemic.

You won't be able to join if your doctor believes, for any reason, that the study isn't suitable for you. This could include if you’ve had a serious allergic reaction to upadacitinib or any of its ingredients before, or if you had a bad side effect in the earlier studies that makes this study unsafe for you. Additionally, if you have an active or long-lasting infection that worries your doctor, or if you were found to have certain types of abnormal cell changes or cancer in your colon during your last endoscopy from the previous studies, you wouldn't be able to participate.

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. Are you between 18 and 75 years old?
  2. Do you have Crohn's disease?
  3. Did you take part in the M14-431 or M14-433 studies and respond well to treatment?
  4. Do you not have any active or serious long-term infections that concern your doctor?
  5. Have you not had a known serious allergic reaction to upadacitinib or its ingredients?
  6. Have you not been found to have certain abnormal cell changes or cancer in your colon?
Answer every question to see your result.

What does participation involve?

If you join this study, your participation will involve continuing with treatment, either with upadacitinib or a placebo (a dummy pill). You'll have regular hospital visits for check-ups and assessments, which might include blood tests, physical examinations, and possibly endoscopies (a procedure to look inside your gut with a camera). These visits help the study team monitor your health, how the medicine is working, and if you experience any side effects. The study aims to follow participants over a long period to see the lasting effects of the treatment.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is the chance to continue with a treatment that has previously shown a positive effect on your Crohn's disease, and to be closely monitored by medical professionals. This could potentially improve your symptoms and overall quality of life. However, like all medicines, upadacitinib has potential side effects, and some participants may receive a placebo, meaning their Crohn's disease might not improve or could even worsen. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (466)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • East View Medical Research, LLC /ID# 171132
    Verified postcode
    Mobile, United States
  • CB Flock Research Corporation /ID# 166239
    Verified postcode
    Mobile, United States
  • Delsol Research Management, Ll /Id# 170164
    Verified postcode
    Chandler, United States
  • Duplicate_HonorHealth Research Institute - Shea /ID# 164725
    Verified postcode
    Scottsdale, United States
  • Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702
    Verified postcode
    Sun City, United States
  • Southern California Res. Ctr. /ID# 169653
    Verified postcode
    Coronado, United States
  • Citrus Valley Gastroenterology /ID# 166230
    Verified postcode
    Covina, United States
  • Hoag Memorial Hosp Presbyterian /ID# 222538
    Verified postcode
    Irvine, United States
  • UC San Diego Health System /ID# 164763
    Verified postcode
    La Jolla, United States
  • United Medical Doctors /ID# 207458
    Verified postcode
    Los Alamitos, United States
  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164640
    Verified postcode
    Los Angeles, United States
  • Facey Medical Foundation /ID# 203138
    Verified postcode
    Mission Hills, United States

Common questions

What is upadacitinib?

Upadacitinib is an experimental medicine in tablet form being tested to treat Crohn's disease by targeting specific inflammation signals in the body.

Who can join this study?

This study is for adults (18-75) with Crohn's disease who have already taken part in and responded well to treatment in previous upadacitinib studies (M14-431 or M14-433).

Will I definitely receive the study medicine?

Not necessarily. Some participants will continue with upadacitinib, while others might receive a placebo (an inactive tablet) as part of the study design.

What's the main goal of this study?

The main goal is to find out how effective and safe upadacitinib is as a long-term treatment for Crohn's disease over an extended period.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, and this will not affect your ongoing medical care.

How to find out more

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

Discussion

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