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Upadacitinib for Ulcerative Colitis
Study Summary
This trial will study the safety and efficacy of Upadacitinib in UC patients who haven't responded to other treatments.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I am following the required birth control guidelines.If female, participant must meet the criteria for Contraception Recommendations.My last endoscopy showed cancer or serious cell changes in my digestive tract.I have only had nonmelanoma skin cancer or localized cervical cancer, both treated successfully.I am 16 or 17 years old and can join the trial if it's allowed in my area.I am pregnant or might become pregnant during the study or within 30 days after the last dose.I am 16 or 17 years old and can join the trial if it's allowed in my area.I do not have active or untreated latent tuberculosis.I am a woman who can have children and my pregnancy test was negative.
- Group 1: Participants receiving Upadacitinib (ABT-494) Dose A
- Group 2: Participants receiving Upadacitinib (ABT-494) Dose B
- Group 3: Participants receiving Upadacitinib (ABT-494) Dose C
- Group 4: Participants receiving Placebo
- Group 5: Participants receiving Upadacitinib (ABT-494) Dose A or Dose B
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this trial still enrolling patients that are relatively young?
"According to the eligibility requirements posted for this clinical trial, potential participants must be between 16 and 75 years old. There are 77 other trials available for people under 18 and 378 for seniors."
Is this research being conducted for the first time?
"Upadacitinib (ABT-494) has been trialed in 21 studies since 2015, with the first being a Phase 3 sponsored by AbbVie. These trials have taken place in 953 cities and 54 countries, involving 18248 total participants."
What other scientific investigations have included Upadacitinib (ABT-494)?
"Upadacitinib (ABT-494) is being investigated in 21 active studies, 14 of which are in Phase 3. The majority of clinical trials for Upadacitinib (ABT-494) are based in Hong Kong and Ciudad De Mexico, but there are a total of 3924 locations running studies on the medication."
Are there any safety concerns with Upadacitinib (ABT-494)?
"Upadacitinib (ABT-494) is a medication that has demonstrated some efficacy in clinical trials and has received a score of 3 for safety."
How many different sites are participating in this research project?
"There are over 100 enrolment locations for this trial, including Ctr for Gastrointestinal Healt /ID# 153369 in Franklin, Virginia, Washington Gastroenterology Associates /ID# 163630 in Bellevue, Washington, and The Ottawa Hospital /ID# 151817 in Ottawa, Ontario."
Could you explain the general purpose of Upadacitinib (ABT-494)?
"Upadacitinib (ABT-494) is an effective systemic therapy for patients suffering from rheumatoid arthritis and methotrexate."
Could I join this clinical research project?
"This ongoing medical trial is looking for 950 ulcer patients that meet the age criteria of 16-75. In addition, these volunteers must have not responded to prior treatments, lost response to maintenance treatment, or successfully completed study M14-234 Substudy 3. Due to the COVID-19 pandemic, participants that have missed endoscopy appointments may still be eligible for the study if they meet additional criteria. Lastly, participants must be in good health as determined by the principal investigator and must use contraception if female."
Are patients able to sign up for this clinical trial at this moment?
"Unfortunately, this particular study is not recruiting patients at this time. However, there are many other trials (440) that are still looking for participants."
How many individuals are currently enrolled in this trial?
"As of now, this clinical trial is no longer recruiting patients. This study was originally posted on 2017-01-31 and was last edited on 2022-01-18. However, there are 419 other clinical trials for ulcers and 21 studies regarding Upadacitinib (ABT-494) that are still looking for willing participants."
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