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 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

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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