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

NCT02155335 | Completed Phase 4 Results

• 2 other identifiers: 8259-0272014-000656-29
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Prefilled Syringe→Smartject™ Device

EXPERIMENTAL

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

Smartject™ Device→ Prefilled Syringe

EXPERIMENTAL

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

Interventions

Prefilled Syringe delivery of Golimumab DRUG

Golimumab 50 mg solution for subcutaneous injection using prefilled syringe

Prefilled Syringe→Smartject™ Device

Smartject Device delivery of Golimumab DRUG

Golimumab 50 mg solution for subcutaneous injection using Smartject Device.

Smartject™ Device→ Prefilled Syringe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 29920582 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: July 1, 2014
• Primary Completion: October 5, 2015
• Study Completion: October 5, 2015
• Last Updated: March 15, 2019
• Results First Posted: January 9, 2017

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share