Completed PHASE3 INTERVENTIONAL 6-arm NCT00488631

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Sponsor: Janssen Research & Development, LLC

Conditions Colitis, Ulcerative

Interventions Golimumab 100 mg Golimumab 200 mg Golimumab 50 mg Placebo

Updated 8 times since 2017 Last updated: Mar 24, 2016 Started: Sep 30, 2007 Primary completion: Oct 31, 2011 Completion: Feb 28, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Colitis, Ulcerative and is currently completed. Janssen Research & Development, LLC leads this study, which shows 8 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jun 2022 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Jun 2022 [monthly]

Completed PHASE3

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Sep 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Janssen Research & Development, LLC
Merck Sharp & Dohme LLC

Data source: Janssen Research & Development, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aachen, Germany , Aalborg, Denmark , Aarhus C, Denmark , Adelaide, Australia , Afula, Israel , Amiens Cedex 1 80, France , Amsterdam, Netherlands , Anaheim, United States , Ann Arbor, United States , Arlington Heights, United States and 285 more locations