Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission (UC-GOL)

Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis

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.

Study Overview

• Status: Unknown
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: Golimumab

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Silvio Danese, MD, PhD; Phone Number: 5555 0039028224; Email: sdanese@hotmail.com
• Study Contact Backup: Name: Gionata Fiorino, MD, PhD; Phone Number: 5555 0038028224; Email: gionata.fiorino@humanitas.it

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Recruiting
      • IBD Center
      • Contact: Silvio Danese, MD, PhD; Phone Number: 5555 0039028224; Email: sdanese@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Golimumab; Subcutaneous golimumab	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; Other Names: Simponi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical and endoscopic steroid-free remission	Total Mayo score ≤2, with no sub-score >1. No concomitant corticosteroid therapy.	week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical response	Decrease in total Mayo score of at least 2 point and 30 %	week 16
percentage of patients in clinical and endoscopic remission	Total Mayo score ≤2, with no sub-score >1	week 52
percentage of patients in clinical remission	partial Mayo score ≤2, with no sub-score >1	week 52
percentage of patients with mucosal healing	complete mucosal healing: endoscopic sub-score 0	week 16 and 52
percentage of patients with histological healing	histological healing: Geboes score <3 and no Mayo sub-score >1	week 16 and 52
quality of life	IBDQ questionnaire	week 16 and 52
percentage of infliximab responders		week 52
identification of patients that would benefit from golimumab therapy	evaluation of baseline characteristics of patients to identify potential response-predictive factors.	through week 52

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Study Chair: Silvio Danese, MD, PhD, IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Estimate): April 8, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: ulcerative colitis; golimumab; steroid-dependent
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Golimumab
• Other Study ID Numbers: 1371