Recruitment

Recruitment Status
Completed
Estimated Enrollment
200

Inclusion Criteria

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.
Diagnosis of ulcerative colitis for at least 3 months with moderate-to-severe disease at enrollment.
...
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.
Diagnosis of ulcerative colitis for at least 3 months with moderate-to-severe disease at enrollment.
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).
Must be naïve to anti-tumor necrosis factor (anti-TNF) therapy.
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.
Has a rectal bleeding subscore of 1 or more at baseline.

Exclusion Criteria

Has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
Has evidence of pathogenic bowel infection.
Has a current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
...
Has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
Has evidence of pathogenic bowel infection.
Has a current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
Has received methotrexate within 12 weeks prior to enrollment
Has a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
Has received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 8 weeks prior to study inclusion.
Has ulcerative colitis which is confined to a proctitis (distal 15 cm or less).
Clinical signs of ischaemic colitis, fulminant colitis or toxic megacolon.
Has used any investigational drugs within 30 days of Screening.
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.
Pregnant or lactating, or planning pregnancy while enrolled in the study.
Has had surgery as a treatment for ulcerative colitis, or is likely to require surgery.
Has a current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 3 months of baseline.
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)

Summary

Conditions
Ulcerative Colitis
Type
Interventional
Phase
Phase 4
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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) an...

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).

Inclusion Criteria

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.
Diagnosis of ulcerative colitis for at least 3 months with moderate-to-severe disease at enrollment.
...
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.
Diagnosis of ulcerative colitis for at least 3 months with moderate-to-severe disease at enrollment.
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).
Must be naïve to anti-tumor necrosis factor (anti-TNF) therapy.
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.
Has a rectal bleeding subscore of 1 or more at baseline.

Exclusion Criteria

Has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
Has evidence of pathogenic bowel infection.
Has a current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
...
Has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
Has evidence of pathogenic bowel infection.
Has a current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
Has received methotrexate within 12 weeks prior to enrollment
Has a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
Has received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 8 weeks prior to study inclusion.
Has ulcerative colitis which is confined to a proctitis (distal 15 cm or less).
Clinical signs of ischaemic colitis, fulminant colitis or toxic megacolon.
Has used any investigational drugs within 30 days of Screening.
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.
Pregnant or lactating, or planning pregnancy while enrolled in the study.
Has had surgery as a treatment for ulcerative colitis, or is likely to require surgery.
Has a current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 3 months of baseline.
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)

Tracking Information

NCT #
NCT02092285
Collaborators
Not Provided
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
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