Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)

• Status: Completed
• Trial end date: 2015-10-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Antibodies, Monoclonal; Golimumab

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.