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

NCT02412085 | Unknown Phase 4

• 1 other identifier: 1371
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

golimumab; ulcerative colitis; steroid-dependent

Outcome Measures

Primary Outcomes (1)

• clinical and endoscopic steroid-free remission

  Total Mayo score ≤2, with no sub-score \>1. No concomitant corticosteroid therapy.

  week 16

Secondary Outcomes (8)

• clinical response

  week 16

• percentage of patients in clinical and endoscopic remission

  week 52

• percentage of patients in clinical remission

  week 52

• percentage of patients with mucosal healing

  week 16 and 52

• percentage of patients with histological healing

  week 16 and 52

Study Arms (1)

Golimumab

EXPERIMENTAL

Subcutaneous golimumab

Drug: Golimumab

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

Also known as: Simponi

Golimumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18-65 years
• ability to understand the study procedures and sign the informed consent
• ulcerative colitis diagnosed at least 6 months before
• no previous exposure to anti-TNFs
• Global Mayo score ≥ 6 (with endoscopic sub-score ≥2) at baseline
• steroid-dependent disease
• women of childbearing potential must accept effective contraception during study participation and for at leas 6 months after the end of study participation

You may not qualify if:

• Crohn's disease or undetermined colitis
• active infections or previous infections not completely resolved at baseline
• malignancies in the previous 5 years
• suspected latent tuberculosis infection
• every other potentially harmful clinical condition, in the opinion of the investigator
• patients with moderately to severe heart failure (NYHA class III/IV)
• hepatic or renal failure
• pregnant or lactating women or women planning a pregnancy between baseline and the 3 months after study completion
• not permitted concomitant medications

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IBD Center

Rozzano, MI, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

golimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Silvio Danese, MD, PhD

  IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY

  STUDY CHAIR

Central Study Contacts

Silvio Danese, MD, PhD

CONTACT

0039028224; sdanese@hotmail.com

Gionata Fiorino, MD, PhD

CONTACT

0038028224; gionata.fiorino@humanitas.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 8, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

IT (1)