Group 3: ustekinumab approximately 6 mg/kg

DRUG2 trials

Sponsors

Janssen Research & Development, LLC

Conditions

ColitisCrohn's DiseaseIBDInflammatory Bowel Disease

Phase 3

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

CompletedNCT01369342

Janssen Research & Development, LLCColitis, Crohn's Disease, IBD +1

Start: 2011-07-31End: 2014-10-31Updated: 2017-01-06

A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)

CompletedNCT01369329

Janssen Research & Development, LLCColitis, Crohn's Disease, IBD +1

Start: 2011-07-31End: 2013-07-31Updated: 2016-12-07

Related Papers

Efficacy and safety of ustekinumab in Asian patients with moderately to severely active Crohn's disease: a small subpopulation analysis of UNITI/IM-UNITI long-term extension through 5 years.

2026-07-10

Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis.

2024-08-0118 citations

Evolution of Symptoms After Ustekinumab Induction Therapy in Patients With Crohn’s Disease

Clinical Gastroenterology and Hepatology2023-06-289 citations

Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease.

2023-06-2710 citations

Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease.

2022-09-2129 citations

The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A <i>post hoc</i> analysis of the UNITI studies

United European Gastroenterology Journal2021-06-0133 citations

Ustekinumab in Paediatric Patients with Moderately to Severely Active Crohn’s Disease: Pharmacokinetics, Safety, and Efficacy Results from UniStar, a Phase 1 Study

Journal of Crohn s and Colitis2021-05-2461 citations

Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies

Inflammatory Bowel Diseases2020-09-23112 citations

Week 6 Calprotectin Best Predicts Likelihood of Long-term Endoscopic Healing in Crohn’s Disease: A Post-hoc Analysis of the UNITI/IM-UNITI Trials

Journal of Crohn s and Colitis2020-09-1122 citations

Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn’s Disease

Gastroenterology2019-07-0465 citations

Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs

Drug Safety2019-02-08114 citations

Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease.

2018-08-29139 citations

Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease.

2018-02-01188 citations

Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies

Intestinal Research2017-01-0123 citations

Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease.

2016-11-011340 citations

Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease

New England Journal of Medicine2013-08-212650 citations