ImproveCareNow Interventional_Research
Community Learning About Results of Engagement Study - CLARE Study
Principal Investigator: Kevin Hommel, PhD - Cincinnati Children's Hospital Medical Center
Purpose: Those participating in intervention groups may experience improvements in their treatment adherence, better self-monitoring, and goal setting. Participants may benefit from connections made via ICN conferences. Improved engagement in their own care may be associated with better health outcomes. This study may have a significant impact on patient care and empowerment in several ways through improving access to self-management care and
facilitating the process of communicating information to patients.
Specific Aims/Hypothesis
This study will assess the efficacy, feasibility, and acceptability of the SMART-IBD app and WINWIN resources on clinical outcomes in adolescents and young adults with IBD.
- Hypothesis 1: Compared to patients not using the SMART-IBD app, those using the app will have better disease activity score (primary outcome) and better symptoms, self-efficacy, and health-related quality of life (secondary
outcome). - Hypothesis 2: Compared to patients not in the WINWIN condition, those getting WINWIN will have better disease activity (primary outcome) and symptoms, self-efficacy, and health-related quality of life (secondary outcome).
- Hypothesis 3: Compared to any other condition, patients with combination SMART-IBD and WINWIN (What I Need, When I Need It) will have better disease activity (primary outcome) and symptoms, self-efficacy, and health-related quality of life (secondary outcome).
Funding Source (Year Awarded): The David R. Clare and Margaret C. Clare Foundation
Study Period: 11/1/24 - 10/31/28
Contact: [email protected]
A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age with Moderately to Severely Active Ulcerative Colitis
Read more about the SHINE-2 study here!
Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-Release Tablets in Pediatric Subjects With Active, Mild to Moderate Ulcerative Colitis
Primary Investigator: Dr. Marian Pfefferkorn, Dr. Gitit Tomer, Dr. Chetan Mandelia, Dr. Michael Kurtz
Purpose: The investigational product, Budesonide Extended-Release tablet, is a glucocorticosteroid that is administered orally. UCERIS® (budesonide) extended release 9mg tablets was approved for adults in 2013 for the induction of remission in adult patients with active, mild-to-moderate UC, and may provide a useful therapeutic option for pediatric patients with UC.
It's an advantageous therapy because it has a hard enteric capsule that inhibits systemic absorption as it travels through the patient's body to the site of disease activity, where it will be 90% absorbed and delivered along the inflamed areas of the colon, thus making it possible to be used as a long-term therapy. Typical steroid therapies risk systemic exposure in the body and are not a long-term solution for children because they disrupt hormones, growth, etc. This medicine is also an alternative to costly biologic therapies. Various formulations of budesonide are approved in the US for therapeutic areas including allergic rhinitis, asthma, and inflammatory bowel disease (IBD; including both Crohn's disease [CD] and Ulcerative colitis (UC).
Aims & Hypothesis: This study aims to put inflammation into remission without the cost of biologics or risk of other systemic steroids. The primary objective of this study is to evaluate the efficacy and safety of a low and a high dose of budesonide extended-release tablets in pediatric subjects with active, mild to moderate UC. The secondary objective is to evaluate the pharmacokinetics of budesonide after oral administration of budesonide extended-release tablets in pediatric subjects with active, mild to moderate UC. The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of ≤ 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of ≤ 1 for endoscopy.
Study Period: May 2024
Contact: [email protected]
A Randomized, Double-Blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-Release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis
Purpose: The purpose of this study is to determine if ulcerative colitis pediatric patients can maintain remission on a 1.6 mg vs. 2.4 mg weight-based dosing of mesalamine DR (Delzicol).
Specific Aims:
Using adult studies as a guide, we aim to compare two weight-based, parallel arms of 2.4 mg vs 1.6 mg in maintaining UC remission over 26 weeks using the modified Mayo Score and other Mayo score derivatives. Pediatric patients will be aged 5-17 and must have been on a stable dose of mesalamine or 5 ASA equivalent for 30 days prior to enrollment and must be in remission for 30 days. Dosing choices are taken from adult maintenance mesalamine dosing.
Study Period: May 2022-March 2024
Contact: Charlotte Glenn, MD - AbbVie