Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission

NCT02412085 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-04-08

No results posted yet for this study

Summary

This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14.

At week 16, patients achieving clinical and endoscopic remission will continue with Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.

Patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. This is not considered as an interventional arm but, since infliximab in Italy is considered as the first-line treatment for UC patients, as the usual clinical practice.

Conditions

Colitis, Ulcerative

Interventions

DRUG

Golimumab

Subcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2) Maintenance regimen: * body weight \< 80kg: 50 mg every 4 weeks * body weight ≥ 80 kg: 100 mg every 4 weeks

Sponsors & Collaborators

Istituto Clinico Humanitas
lead OTHER

Principal Investigators

Silvio Danese, MD, PhD · IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY

Study Design

Allocation: NA
Purpose: TREATMENT
Masking: NONE
Model: SINGLE_GROUP

Eligibility

Min Age: 18 Years
Max Age: 65 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2015-03-31
Primary Completion: 2016-12-31
Completion: 2017-01-31

Countries

Italy

Study Locations

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Entities

Drugs

Golimumab