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Trial record 2 of 27 for:    golimumab, ulcerative colitis

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02092285
First received: March 18, 2014
Last updated: May 26, 2016
Last verified: May 2016
  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: 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 ]

Enrollment: 205
Study Start Date: May 2014
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Golimumab
The first induction 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) every 4 weeks 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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02092285

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02092285     History of Changes
Other Study ID Numbers: 8259-032
2013-004583-56 ( EudraCT Number )
Study First Received: March 18, 2014
Last Updated: May 26, 2016

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017