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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Ulcerative Colitis

Treatments: Drug: Smartject Device delivery of Golimumab; Drug: Prefilled Syringe delivery of Golimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02155335

8259-027

2014-000656-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Prefilled Syringe→Smartject™ Device

Experimental group

Description:

Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab).

Treatment:

Drug: Prefilled Syringe delivery of Golimumab

Smartject™ Device→ Prefilled Syringe

Experimental group

Description:

Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.

Treatment:

Drug: Smartject Device delivery of Golimumab