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

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Unknown status

CT.gov ID

NCT02412085

Collaborator

(none)

100

Enrollment

Location

Arm

22.1

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colitis, Ulcerative	Drug: Golimumab	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Jan 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

clinical and endoscopic steroid-free remission [week 16]
Total Mayo score ≤2, with no sub-score >1. No concomitant corticosteroid therapy.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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