Open-Label Induction and Maintenance Study of Oral CP-690,550 (TOFACITINIB) in Children with Moderately to Severely Active Ulcerative Colitis
Published: 03/28/2022
General Information:
The primary objective of this study is to evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC. The primary endpoint is remission by central read Mayo score following 44 weeks in the maintenance phase. Remission is defined by a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.
Eligibility:
This study may be an option for patients:
- who are aged between 2 and 17 years old
- who have been diagnosed with moderate to severe ulcerative colitis for at least 3 months
- in the United States:
- Have had an inadequate response or intolerance to TNF inhibitors
- outside of the United States:
- Have had an inadequate response or been intolerant to at least one prior therapy as listed here or have a medical contradiction to such therapies: Oral or intravenous (IV) corticosteroids, Azathioprine or 6-mercaptopurine, TNF inhibitors or anti integrin therapy.
Study Details:
Study description:
The OVATION study is designed to assess the safety and effectiveness of an investigational study drug in children and adolescents with moderately to severely active ulcerative colitis. The study drug is an investigational drug because it is not yet approved for use in children or adolescents with ulcerative colitis.
Approximately 120 children and adolescents will join the OVATION study from countries all over the world.
Description of treatment or intervention (mechanism of action):
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The study drug is offered as tablets or a liquid to be given twice a day at home.
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The study drug has a novel mechanism of action and is known to play a central role in the immune response by blocking inflammation.
Patient participation requirements:
Children who join the OVATION study will receive the study drug twice a day at home, either as tablets or a liquid. They will take part for up to 43 months depending on how long they receive the study drug, and they would attend up to 23* clinic visits with one follow-up telephone call.
All study participants will be monitored frequently and supported by study site staff. Procedures to make sure patients are doing well will be required in this study; some of them are endoscopies, health questions, physical examinations, blood, urine and stool samples, and a daily bowel movement diary.
Possible risks and side effects:
- Study participants may find that symptoms of flare-ups are different than when first diagnosed.
- Participants may experience persistent stomach aches, fever, diarrhea, urgent bowel movement, blood in their stools, weight loss or general ill health.
- It is important that the patient or caregiver mention any concerns to their usual doctor or the study team.