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

Colitis, Ulcerative Clinical Trial

— UC-GOL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02412085
• Other study ID #: 1371
• Status: Recruiting
• Phase: Phase 4
• First received: March 26, 2015
• Last updated: April 7, 2015
• Start date: March 2015
• Est. completion date: January 2017

Study information

• Verified date: April 2015
• Source: Istituto Clinico Humanitas
• Contact: Silvio Danese, MD, PhD
• Phone: 0039028224
• Email: sdanese[@]hotmail.com
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Italy	IBD Center	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

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