Clinical Trials

A 5-Year Non-interventional Registry Study of Humira (Adalimumab) in Patients With Moderately to Severely Active Crohn's Disease (CD)- Protocol P06-134. Status: Ongoing ~ Follow up. Principal Investigator: Daniel Stein, MD

SECURE: A Non-Interventional Long-term Post-Marketing Registry of Patients Treated with Certolizumab Pegol (Cimzia®) for Crohn's Disease. Status: Ongoing ~ Enrolling. Principal Investigator: Daniel Stein, MD

C13008: A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease. Status: Ongoing ~ Follow up. Principal Investigator: Daniel Stein, MD

STOP-HE Study -Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (ornithine phenylacetate) in Hospitalized Patients with Cirrhosis and Associated Hyperammonemia with an Episode of Hepatic Encephalopathy. Principal Investigator: Kia Saeian, MD

CLARITY-Clinical Investigation to evaluate removal of the Evolution® esophageal stent–fully covered. Principal Investigator: Kulwinder Dua, MD

LEGACY-A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC). Principal Investigator: Daniel Stein, MD

A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease-RHB-104-01. Ongoing ~ Enrolling. Principal Investigator: Daniel Stein, MD

A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration-M14-115. Ongoing ~ Enrolling. Principal Investigator: Daniel Stein, MD

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis-M14-033. Ongoing ~ Enrolling. Principal Investigator: Daniel Stein, MD

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease-M14-347. Ongoing ~ Enrolling. Principal Investigator: Daniel Stein, MD

Phase III, Double Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Inducton and Maintenance in Patients with Moderate to Severe Active Ulcerative Colitis Who Are Refractory to or Intolerant of TNF Inhibitors-GA28950. Ongoing ~ Enrolling. Principal Investigator: Daniel Stein, MD

Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared with Placebo in Patients with Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors-GA29102. Ongoing ~ Enrolling. Principal Investigator: Daniel Stein, MD

An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase III Studies-GA28951. Ongoing ~ Enrolling. Principal Investigator: Daniel Stein, MD

Randomized Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients with Pancreatic Cancer-E7034. Ongoing ~ Enrolling. Principal Investigator: Kulwinder Dua, MD

Prospective, Multicenter, Single Blind, Randomized Study Comparing the EndoMAXX EVT Fully Covered Esophageal Stent with Valve to the EndoMAXX Fully Covered Esophageal Stent for Malignant Strictures Requiring Stent Placement Across the Gastroesophageal Junction-EVOLVE. Ongoing ~ Enrolling. Principal Investigator: Kulwinder Dua, MD

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Page Updated 03/23/2015
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