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Trial record 2 of 21 for:    golimumab, ulcerative colitis

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02155335
First received: June 2, 2014
Last updated: October 14, 2015
Last verified: October 2015
  Purpose
This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.

Condition Intervention Phase
Ulcerative Colitis
Drug: Golimumab Prefilled Syringe
Drug: Golimumab Smartject™ Device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preference for a Prefilled Syringe or Smartject™ Device for Delivering SIMPONI (Golimumab) in Patients Suffering From Moderate to Severe Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or are Undecided [ Time Frame: Up to Week 2 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2014
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Golimumab Prefilled Syringe
Golimumab 50 mg supplied in a prefilled syringe administered four times (two times by the treating physician and 2 times by the participant under the supervision of the treating physician).
Drug: Golimumab Prefilled Syringe
Golimumab 50 mg via subcutaneous injection.
Other Names:
  • SIMPONI
  • MK-8259-027
Experimental: Golimumab Smartject™ Device
Golimumab 50 mg supplied in an auto-injector device administered four times (two times bythe treating physician and 2 times by the participant under the supervision of the treating physician).
Drug: Golimumab Smartject™ Device
Golimumab 50 mg via subcutaneous injection.
Other Names:
  • SIMPONI
  • MK-8259-027

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02155335

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02155335     History of Changes
Other Study ID Numbers: 8259-027  2014-000656-29 
Study First Received: June 2, 2014
Last Updated: October 14, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016