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

NCT ID: NCT02155335

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-01
• Study Completion Date: 2015-10-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Prefilled Syringe delivery of Golimumab

Intervention Type: DRUG

Golimumab 50 mg solution for subcutaneous injection using prefilled syringe

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.

Group Type: EXPERIMENTAL

Smartject Device delivery of Golimumab

Intervention Type: DRUG

Golimumab 50 mg solution for subcutaneous injection using Smartject Device.

Interventions

Prefilled Syringe delivery of Golimumab

Golimumab 50 mg solution for subcutaneous injection using prefilled syringe

Intervention Type: DRUG

Smartject Device delivery of Golimumab

Golimumab 50 mg solution for subcutaneous injection using Smartject Device.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 29920582 (View on PubMed)

Other Identifiers

2014-000656-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8259-027

Identifier Type: -

Identifier Source: org_study_id