Clinical trial NCT02155335: Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)
Official title: Preference for a Prefilled Syringe or Smartject™ Device for Delivering SIMPONI (Golimumab) in Patients Suffering From Moderate to Severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ulcerative Colitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections)
timeFrame: Day 0 (post last injection)
measure: Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections)
timeFrame: Day 14 (2 weeks post injections)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Bossuyt P, Baert F, D'Heygere F, Nakad A, Reenaers C, Fontaine F, Franchimont D, Dewit O, Van Hootegem P, Vanden Branden S, Lambrecht G, Ferrante M; Belgian IBD Research and Development Group. Early Mucosal Healing Predicts Favorable Outcomes in Patients With Moderate to Severe Ulcerative Colitis Treated With Golimumab: Data From the Real-life BE-SMART Cohort. Inflamm Bowel Dis. 2019 Jan 1;25(1):156-162. doi: 10.1093/ibd/izy219.