search
Back to results

Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) (GO-COLITIS)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Golimumab
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of ulcerative colitis for at least 3 months with moderate-to-severe disease at enrollment.
  • Has a rectal bleeding subscore of 1 or more at baseline.
  • No evidence of active, or latent, or inadequately treated infection with Mycobacterium tuberculosis (TB).
  • Must be eligible to start golimumab treatment according to the summary of product characteristics.
  • Must be naïve to anti-tumor necrosis factor (anti-TNF) therapy.
  • Women of childbearing potential or men capable of fathering children must agree to use adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implant, surgical sterilization).
  • Women of childbearing potential must test negative for pregnancy at screening.
  • Any prior azathioprine / 6-mercaptopurine use was initiated at least 12 weeks prior to enrollment with either stable dosing or discontinued treatment for the 4 weeks immediately prior to enrollment.

Exclusion Criteria:

  • Clinical signs of ischaemic colitis, fulminant colitis or toxic megacolon.
  • Has evidence of pathogenic bowel infection.
  • Has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
  • Has had surgery as a treatment for ulcerative colitis, or is likely to require surgery.
  • Has ulcerative colitis which is confined to a proctitis (distal 15 cm or less).
  • Has a current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
  • Has a current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 3 months of baseline.
  • Pregnant or lactating, or planning pregnancy while enrolled in the study.
  • Has received agents that deplete B or T cells (eg, rituximab or alemtuzumab) within 12 months prior to study inclusion, or continue to manifest depletion of B or T cells more than 12 months after completion of therapy with lymphocyte-depleting agents.
  • Has received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 8 weeks prior to study inclusion.
  • Has used any investigational drugs within 30 days of Screening.
  • Has a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
  • Has received methotrexate within 12 weeks prior to enrollment
  • Has received rectal corticosteroids or rectal 5-aminosalicylic acid (5-ASA) compounds within 2 weeks prior to enrollment (may be commenced if required after Week 6 in the study)

Sites / Locations

  • Merck Sharp & Dohme Ltd.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Golimumab

Arm Description

The first induction dose of subcutaneous (SC) golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight <80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.

Outcomes

Primary Outcome Measures

Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54
The Partial Mayo Score (Mayo Score without endoscopy) measures severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment are each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores are then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease). Clinical response is defined as a decrease in PMS of ≥2 points and ≥30% from baseline, plus either a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1. In this outcome measure, the percentage of participants starting treatment at the start of the Induction Phase (Baseline) who obtained clinical response by the end of the Induction Phase (i.e., by Week 6) and maintained clinical response through Week 54 (i.e., had positive clinical responses at both Weeks 30 and 54) are estimated.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2014
Last Updated
February 27, 2019
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT02092285
Brief Title
Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)
Acronym
GO-COLITIS
Official Title
Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 9, 2014 (Actual)
Primary Completion Date
May 25, 2016 (Actual)
Study Completion Date
May 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the efficacy of golimumab in maintaining a clinical response in participants with moderate-to-severe ulcerative colitis.
Detailed Description
This study consists of a 1 week screening period, a 54 week treatment period, and a 12 week follow-up period, requiring a total of 7 trial site visits: Visit 1(screening visit, Week -1), Visit 2 (enrollment visit, Day 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 5 (Week 30) and Visit 6 (Week 54) and Visit 7 (follow-up visit, Week 66).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Golimumab
Arm Type
Experimental
Arm Description
The first induction dose of subcutaneous (SC) golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight <80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
Intervention Type
Drug
Intervention Name(s)
Golimumab
Other Intervention Name(s)
Simponi®
Intervention Description
50mg or 100mg solution for injection; subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54
Description
The Partial Mayo Score (Mayo Score without endoscopy) measures severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment are each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores are then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease). Clinical response is defined as a decrease in PMS of ≥2 points and ≥30% from baseline, plus either a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1. In this outcome measure, the percentage of participants starting treatment at the start of the Induction Phase (Baseline) who obtained clinical response by the end of the Induction Phase (i.e., by Week 6) and maintained clinical response through Week 54 (i.e., had positive clinical responses at both Weeks 30 and 54) are estimated.
Time Frame
Baseline (Week 0), Week 6, Week 30, Week 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of ulcerative colitis for at least 3 months with moderate-to-severe disease at enrollment. Has a rectal bleeding subscore of 1 or more at baseline. No evidence of active, or latent, or inadequately treated infection with Mycobacterium tuberculosis (TB). Must be eligible to start golimumab treatment according to the summary of product characteristics. Must be naïve to anti-tumor necrosis factor (anti-TNF) therapy. Women of childbearing potential or men capable of fathering children must agree to use adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implant, surgical sterilization). Women of childbearing potential must test negative for pregnancy at screening. Any prior azathioprine / 6-mercaptopurine use was initiated at least 12 weeks prior to enrollment with either stable dosing or discontinued treatment for the 4 weeks immediately prior to enrollment. Exclusion Criteria: Clinical signs of ischaemic colitis, fulminant colitis or toxic megacolon. Has evidence of pathogenic bowel infection. Has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease. Has had surgery as a treatment for ulcerative colitis, or is likely to require surgery. Has ulcerative colitis which is confined to a proctitis (distal 15 cm or less). Has a current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease. Has a current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 3 months of baseline. Pregnant or lactating, or planning pregnancy while enrolled in the study. Has received agents that deplete B or T cells (eg, rituximab or alemtuzumab) within 12 months prior to study inclusion, or continue to manifest depletion of B or T cells more than 12 months after completion of therapy with lymphocyte-depleting agents. Has received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 8 weeks prior to study inclusion. Has used any investigational drugs within 30 days of Screening. Has a known hypersensitivity to human immunoglobulin proteins or other components of golimumab. Has received methotrexate within 12 weeks prior to enrollment Has received rectal corticosteroids or rectal 5-aminosalicylic acid (5-ASA) compounds within 2 weeks prior to enrollment (may be commenced if required after Week 6 in the study)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Merck Sharp & Dohme Ltd.
City
Hoddesdon
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
30002864
Citation
Probert CS, Sebastian S, Gaya DR, Hamlin PJ, Gillespie G, Rose A, Tate H, Wheeler C, Irving PM. Golimumab induction and maintenance for moderate to severe ulcerative colitis: results from GO-COLITIS (Golimumab: a Phase 4, UK, open label, single arm study on its utilization and impact in ulcerative Colitis). BMJ Open Gastroenterol. 2018 Jul 7;5(1):e000212. doi: 10.1136/bmjgast-2018-000212. eCollection 2018.
Results Reference
derived

Learn more about this trial

Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)

We'll reach out to this number within 24 hrs