Phase 4
Completed N=100
Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)
Source: ClinicalTrials.gov NCT02155335 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections) — 20.9; 76.9; 2.2 Percentage of Participants
◆ Published Evidence
Established
32citations · ~5 / year
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.
Summary
This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections) |
20.9; 76.9; 2.2 | — |
| PRIMARY Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections) |
26.4; 71.4; 2.2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02155335) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.