Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Prefilled Syringe delivery of Golimumab; Smartject Device delivery of Golimumab
Intervention description: Golimumab 50 mg solution for subcutaneous injection using prefilled syringe; Golimumab 50 mg solution for subcutaneous injection using Smartject Device.
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to determine whether ulcerative colitis participants prefer delivery
      of golimumab via a prefilled syringe or the Smartject™ device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Anti-tumor necrosis factor (anti-TNF) naive participants with a diagnosis of
             moderate-to-severe ulcerative colitis.

          -  Mayo clinic score >= 6, including endoscopic subscore >=2;

          -  Previous conventional therapy for a period of at least 3 months with aminosalicylates
             and at least 3 months with corticosteroids or 6-mercaptopurine (6-MP) or azathioprine
             (AZA), unless the participant is intolerant to, or has contraindications to these
             treatments;

          -  Anti-TNF experienced participants with an established diagnosis of moderate-to-severe
             ulcerative colitis, either not responding or partially responding to treatment with
             Remicade (infliximab). The participant must also meet the following criteria prior to
             initiating first-line anti-TNF treatment: Mayo score ≥ 6, including an endoscopic
             subscore ≥ 2; and previous conventional therapy of at least 3 months with
             aminosalicylates and at least 3 months with corticosteroids or 6-mercaptopurine (6-MP)
             or azathioprine (AZA), unless the participant is intolerant to or have medical
             contraindications for such therapies (should be documented);

          -  Sexually active women of child-bearing potential must agree to use a medically
             accepted method of contraception while receiving study drug and for 6 months after the
             stop of study drug

        Exclusion Criteria:

          -  Has a history of prior self-injection for any reason;

          -  Has concomitant use of other biologic agents;

          -  Has active tuberculosis (TB) within 12 months prior to the first injection or has
             suspected latent TB as indicated by a positive tuberculin skin test.

          -  Has an active clinical non-tuberculous mycobacterial infection or opportunistic
             infection within 6 months prior to the first injection;

          -  Has had an active infection and/or serious infection within 6 months prior to the
             first study drug administration;

          -  Has had a live viral or bacterial vaccination within 3 months prior to the first study
             injection or Bacillus Calmette-Guerin vaccination within 12 months prior to the first
             study drug injection;

          -  Has evidence of heart failure of New York Heart Association class 3-4;

          -  Has a history of demyelinating disease such as multiple sclerosis or optic neuritis;

          -  Has a history of systemic lupus erythematosus;

          -  Has a history of lymphoproliferative disease, or any unknown malignancy or history of
             malignancy within the prior 5 years, with the exception of non-melanoma skin cancer
             that has been treated with no evidence of recurrence;

          -  Has had an active hepatitis B infection;

          -  Has an allergy or sensitivity to golimumab or its excipients;

          -  Is pregnant or breast feeding;

          -  Is sensitive to latex.