Trial record 2 of 8 for:    golimumab, ulcerative colitis

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

This study is not yet open for participant recruitment.
Verified April 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02092285
First received: March 18, 2014
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Drug: Golimumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Proportion of Participants Meeting Partial Mayo Score Response Criteria at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Golimumab
The first dose of subcutaneous (SC) golimumab 200 mg will be administered at Visit 2 (Day 0). The second induction dose of SC golimumab 100 mg will be administered two weeks later at Visit 3 (Week 2). Responders at Visit 4 (Week 6) will receive 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) during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
Drug: Golimumab

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 in 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ulcerative colitis for at least 3 months prior to enrollment.
  • 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, surgical sterilization).
  • Women of childbearing potential must test negative for pregnancy at screening and at Week 0.

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. during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02092285

Contacts
Contact: Toll Free Number 1-888-577-8839 ClinicalTrialsDisclosure@merck.com

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02092285     History of Changes
Other Study ID Numbers: 8259-032, 2013-004583-56
Study First Received: March 18, 2014
Last Updated: April 2, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014