Overview

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.