Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis.

ABSTRACT:

Background

Tumour necrosis factor alpha (TNFα)-antagonism effectively treats ulcerative colitis (UC). The golimumab clinical programme evaluated subcutaneous (SC) and intravenous (IV) induction, and SC maintenance regimens, in TNFα-antagonist-naïve patients with moderate-to-severe active UC despite conventional treatment.

Aim

To evaluate dose-response relationship, select IV golimumab induction doses for continued development, and evaluate the safety and efficacy of selected doses.

Methods

Adults with Mayo scores of 6-12 and endoscopic subscores ≥2 were enrolled into this multicentre, randomised, double-blind, placebo-controlled, integrated Phase 2/3 dose-finding/dose-confirming study. In Phase 2, 176 patients were randomised (1:1:1:1) to a single IV infusion of place

SUBMITTER: Rutgeerts P 

PROVIDER: S-EPMC4755132 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature