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

Primary Purpose

Colitis, Ulcerative

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Golimumab
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring golimumab, ulcerative colitis, steroid-dependent

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IBD CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Golimumab

Arm Description

Subcutaneous golimumab

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2015
Last Updated
April 7, 2015
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02412085
Brief Title
Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
golimumab, ulcerative colitis, steroid-dependent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Golimumab
Arm Type
Experimental
Arm Description
Subcutaneous golimumab
Intervention Type
Drug
Intervention Name(s)
Golimumab
Other Intervention Name(s)
Simponi
Intervention Description
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
Primary Outcome Measure Information:
Title
clinical and endoscopic steroid-free remission
Description
Total Mayo score ≤2, with no sub-score >1. No concomitant corticosteroid therapy.
Time Frame
week 16
Secondary Outcome Measure Information:
Title
clinical response
Description
Decrease in total Mayo score of at least 2 point and 30 %
Time Frame
week 16
Title
percentage of patients in clinical and endoscopic remission
Description
Total Mayo score ≤2, with no sub-score >1
Time Frame
week 52
Title
percentage of patients in clinical remission
Description
partial Mayo score ≤2, with no sub-score >1
Time Frame
week 52
Title
percentage of patients with mucosal healing
Description
complete mucosal healing: endoscopic sub-score 0
Time Frame
week 16 and 52
Title
percentage of patients with histological healing
Description
histological healing: Geboes score <3 and no Mayo sub-score >1
Time Frame
week 16 and 52
Title
quality of life
Description
IBDQ questionnaire
Time Frame
week 16 and 52
Title
percentage of infliximab responders
Time Frame
week 52
Title
identification of patients that would benefit from golimumab therapy
Description
evaluation of baseline characteristics of patients to identify potential response-predictive factors.
Time Frame
through week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvio Danese, MD, PhD
Phone
0039028224
Ext
5555
Email
sdanese@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gionata Fiorino, MD, PhD
Phone
0038028224
Ext
5555
Email
gionata.fiorino@humanitas.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvio Danese, MD, PhD
Organizational Affiliation
IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY
Official's Role
Study Chair
Facility Information:
Facility Name
IBD Center
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvio Danese, MD, PhD
Phone
0039028224
Ext
5555
Email
sdanese@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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