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A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety,
Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric
Participants with Moderately to Severely Active Ulcerative Colitis with an Inadequate Response
to Conventional Therapy
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in causing and maintaining clinical remission.
Ozanimod will be administered orally to pediatric participants with moderate to severe active Ulcerative Colitis who have had an inadequate response to conventional therapy.
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A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy (Vedo CD)
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness, safety, pharmacokinetics (PK), and immune response of high and low doses in 3 different weight groups of vedolizumab intravenous (IV) for maintenance of remission in children aged 2 to 17 years, inclusive, who weigh ≥ 10 kg with moderately to severely active Crohn’s disease (CD).
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Using data from a network of patients, families, clinicians, researchers and health care organizations to improve care and outcomes for children, adolescents and young Inflammatory Bowel Disease
Rochester, Minn.
The purpose is to put the information into a very large database, which can then be used to improve patient care and achieve the best health outcomes possible for children with IBD.
Contact Us for the Latest Status
Closed for Enrollment
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A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn's Disease - CAPE (CAPE)
Rochester, Minn.
The purpose of this study is to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active crohn's disease
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A Multi-Center Observational Study Targeting the Inflammatory Signature to Personalize Biologics in Pediatric IBD (REFINE) (REFINE)
Rochester, Minn.
This study will be a multi-center, longitudinal, observational investigation to collect biospecimens (blood, stool and intestinal biopsies) to support the development of specific biomarkers of treatment response to infliximab and vedolizumab in children with IBD.
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A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PURSUIT 2)
Rochester, Minn.
The purpose of this study is to evaluate effectiveness of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.
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A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label
Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis
Rochester, Minn.
The global primary objectives of this study are, in pediatric participants with moderately to severely active ulcerative colitis (UC):
- To evaluate the efficacy of ustekinumab dosing in inducing clinical remission;
- To evaluate the safety profile of ustekinumab;
- To evaluate ustekinumab exposure (pharmacokinetics [PK]).
The United States (US)-specific primary objectives of this study are, in pediatric participants with moderately to severely active UC:
- To evaluate the efficacy of ustekinumab dosing in maintaining clinical remission among participants who were in clinical response in induction;
- To evaluate the safety profile of ustekinumab;
- To evaluate ustekinumab exposure (pharmacokinetics [PK]).
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A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label
Intravenous Induction Treatment Followed by Randomized Double-blind
Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to
Severely Active Crohn’s Disease
Rochester, Minn.
The primary objective of this study is to evaluatge whether ustekinumab induces a similar proportion of pediatric participants with moderate-to-severe, active Crohn's disease into clinical remission at Week 1-8 compared with the proportion observed in adult participants with moderate-to-severe, active Crohn's disease randomized to ustekinumab in the CNTO1275CRD3001 and CNTO1275CRD3002 studies.
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A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study
Rochester, Minn.
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20 million cells. 20 patients (age 12 to 17 years) with Crohns perianal fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.
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A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study
Rochester, Minn.
The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease. Autologous means these cells to coat the plug come from the patient.
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A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy (Vedo UC)
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness, safety, pharmacokinetics (PK), and immune response of high and low doses in 3 different weight groups of vedolizumab intravenous (IV) for maintenance of remission in children aged 2 to 17 years, inclusive, who weigh ≥ 10 kg, with moderately to severely active ulcerative colitis (UC).
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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF Therapy (COMBINE)
Rochester, Minn.
The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with Crohn's Disease.
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Using data from a network of patients, families, clinicians, researchers and health care organizations to improve care and outcomes for children, adolescents and young Inflammatory Bowel Disease
La Crosse, Wis.,
Mankato, Minn.,
Eau Claire, Wis.
The purpose is to put the information into a very large database, which can then be used to improve patient care and achieve the best health outcomes possible for children with IBD.
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