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

NCT02092285 | Completed Phase 4 Results

• 2 other identifiers: 8259-0322013-004583-56
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Week 0), Week 6, Week 30, Week 54

Study Arms (1)

Golimumab

EXPERIMENTAL

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.

Drug: Golimumab

Interventions

Golimumab DRUG

50mg or 100mg solution for injection; subcutaneous injection

Also known as: Simponi®

Golimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Merck Sharp & Dohme Ltd.

Hoddesdon, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30002864 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

golimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: May 9, 2014
• Primary Completion: May 25, 2016
• Study Completion: May 25, 2016
• Last Updated: March 15, 2019
• Results First Posted: October 13, 2017

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)