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

Preference for a Prefilled Syringe or Smartject™ Device for Delivering SIMPONI (Golimumab) in Patients Suffering From Moderate to Severe Ulcerative Colitis

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Prefilled Syringe delivery of Golimumab; Drug: Smartject Device delivery of Golimumab

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prefilled Syringe→Smartject™ Device; 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).	Drug: Prefilled Syringe delivery of Golimumab; Golimumab 50 mg solution for subcutaneous injection using prefilled syringe
Experimental: Smartject™ Device→ Prefilled Syringe; 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.	Drug: Smartject Device delivery of Golimumab; Golimumab 50 mg solution for subcutaneous injection using Smartject Device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections)	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. Following the completion of the last injection, the participants completed a questionnaire in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.	Day 0 (post last injection)
Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections)	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 than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants completed a questionnaire 2 weeks after the injections in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.	Day 14 (2 weeks post injections)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): October 5, 2015
• Study Completion (Actual): October 5, 2015

Study Registration Dates

• First Submitted: June 2, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 4, 2014

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Antibodies, Monoclonal; Golimumab
• Other Study ID Numbers: 8259-027; 2014-000656-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf