A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Save

Date Added
July 9th, 2019
PRO Number
Pro00088643
Researcher
Brenda Hoffman

List of Studies


Profiles_link
Keywords
Crohn's Disease
Summary

Study M16-006 is a randomized, double blind, placebo-controlled 12-week induction study for those subjects with Moderately to Severely Active Crohn's Disease.
This study will evaluate two IV doses of Risankizumab (600 mg and 1200 mg). The selection of the doses in this study was selected by the data provided from the phase II study that was completed previously. The results from the Phase 2 study suggest a potential for increased benefit with 1200 mg administration.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
forstere@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Save

Date Added
July 9th, 2019
PRO Number
Pro00088554
Researcher
Brenda Hoffman

List of Studies


Profiles_link
Keywords
Crohn's Disease
Summary

Study M15-991 is a randomized, double blind, placebo-controlled 12-week induction study. This study is for those subjects with moderately to severely Active Crohn's Disease Who Failed Prior Biologic Treatment.
This study will evaluate two IV doses of Risankizumab (600 mg and 1200 mg). The selection of the doses in this study was selected by the data provided from the phase II study that was completed previously. The results from the Phase 2 study suggest a potential for increased benefit with 1200 mg administration.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
forstere@musc.edu

A Phase 2 Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety, and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohns Disease. Save

Date Added
February 13th, 2018
PRO Number
Pro00074924
Researcher
Candi Jump

List of Studies

Silhouette
Keywords
Bowel, Crohn's Disease, Digestive System, Pediatrics
Summary

The purpose of this research study is to determine which dose is effective and how the body processes the study drug, vedolizumab in children ages 2-17 who have ulcerative colitis or Crohn's disease.

This phase 2 study includes a 4-week Screening Period, a 22-week
Treatment Period (with last dose at Week 14). Subjects who do not
enter the long term extension study will have an 18-week Follow-up Period starting
from their last dose of study drug and a long-term follow-up safety
survey by telephone 6 months after their last dose of study drug.

Institution
MUSC
Recruitment Contact
Christine Hudson
843-792-0387
hudsoncm@musc.edu

A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease Save

Date Added
February 13th, 2018
PRO Number
Pro00074819
Researcher
Candi Jump

List of Studies

Silhouette
Keywords
Bowel, Crohn's Disease, Digestive System, Pediatrics
Summary

This is a long-term extension study enrolling male and female pediatric subjects with ulcerative colitis (UC) or Crohn's disease (CD) who initiated vedolizumab intravenous (IV) treatment in the phase 2 Study MLN0002-2003 between the ages of 2 and 17 years of age. The study will evaluate the long-term safety of vedolizumab administered by IV infusion in pediatric subjects with UC or CD. The study will also evaluate the effect of long-term vedolizumab IV treatment on the time to major IBD-related events (hospitalizations, surgeries, or procedures), health-related quality-of-life measurements, patterns of growth and development, and exploratory efficacy measures. Up to 80 rollover subjects from Study MLN0002-2003 will participate in this study. Subjects who weigh 30 kg or greater will receive vedolizumab 300 mg (high dose) or 150 mg (low dose) Q8W. Subjects who weight less than 30 kg will receive vedolizumab 200 mg (high dose) or 100 mg (low dose) IV. Patients will receive treatment and perform assessments every 8 weeks for up to 5 years or until the subject withdraws from the study or the sponsor decides to close the study, whichever comes first.

Institution
MUSC
Recruitment Contact
Christine Hudson
843-792-0387
hudsoncm@musc.edu

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 (CD) ? CAPE Save

Date Added
June 16th, 2016
PRO Number
Pro00046546
Researcher
Jose Quiros

List of Studies

Silhouette
Keywords
Bowel, Crohn's Disease, Digestive System, Pediatrics
Summary

A Crohn's Disease Registry for pediatric patients (between the ages of 6 and 17 years) with moderately to severely active Crohn's Disease (CD), who are already taking Humira® (Adalimumab) to treat their condition. Data from the participant's medical record will be collected to study the long-term safety and effectiveness of Humira®. The Registry expects to collect data for 10 years. No study drug will be given.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

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