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

Sponsor
Istituto Clinico Humanitas
Study ID
NCT02412085
Phase
PHASE4
Status
Unknown

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — DRUG
    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

Study Details

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.

Key Dates

Start date
Mar 31, 2015
Status verified
Apr 2015
Primary completion
Dec 31, 2016
Completion
Jan 31, 2017

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Golimumab
    Subcutaneous golimumab

Primary Outcome Measure

clinical and endoscopic steroid-free remission [ Time Frame: week 16 ]

Central Contacts

Related Studies