The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) (GO-EASY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01668004
First received: August 1, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

The objective of this study is to determine the difference in the annual incidence rate of uveitis attacks in participants with ankylosing spondylitis (AS) before treatment and after the start of treatment with golimumab.


Condition Intervention Phase
Ankylosing Spondylitis
Biological: Golimumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Phase 4 Study, Investigating the Incidence of Extra-Articular Manifestations in Subjects With Ankylosing Spondylitis Treated With Golimumab; Protocol No. MK-8259-012

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Annual Incidence Rate of Uveitis Attacks in Participants Before Treatment and After the Start of Treatment with Golimumab [ Time Frame: Twelve Months Prior to Enrollment to Study Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Annual Incidence Rate of New-Onset or Flares of Inflammatory Bowel Disease (IBD) and Psoriasis in Participants Before Treatment and After the Start of Treatment With Golimumab [ Time Frame: Twelve Months Prior to Enrollment to Study Month 12 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) Following Treatment With Golimumab [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in the Ankylosing Spondylitis Disease Activity Score (ASDAS) Following Treatment With Golimumab [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Golimumab 50 mg
Golimumab dosed subcutaneously at a dose of 50 mg once monthly for up to 12 months.
Biological: Golimumab
Golimumab 50 mg subcutaneously once monthly.
Other Name: Simponi®

Detailed Description:

This is an open-label, history-controlled, multi-site study of golimumab in participants with AS. For evaluation of the primary study outcome measure, participants will serve as their own control. The period before start of treatment with an anti-tumor necrosis factor (TNF) agent will serve as historical control for the incidence of extra-articular manifestations, with a review of the medical records done for the previous 1-year period.

Each participant will participate in the study for approximately 12 months from the time the participant signs the Informed Consent Form through the final contact. Two to four weeks before study start, each participant will be receiving study treatment for approximately 12 months, depending on the response to golimumab after 3 months. All participants will be followed for a minimum of 12 months, irrespective of the duration of golimumab treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • May not have been treated with golimumab prior to study enrollment
  • Must be able to provide retrospective data concerning extra-articular manifestations and episodes with a recall period of at least 12 months prior to anti-TNF use
  • Must have definite AS according to the modified New York criteria in the Netherlands
  • Must be candidate for treatment with anti-TNF agent according to the

Assessment of SpondyloArthritis International Society (ASAS) consensus

  • Must be able to adhere to dose and visit schedules

Exclusion Criteria:

  • Any exclusion criteria stated in the Summary of Product Characteristics for golimumab
  • Use of any investigational biological or chemical agents within 30 days or 2 half-lives (whichever is longest) of screening
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01668004     History of Changes
Other Study ID Numbers: 8259-012, 2012-002458-21
Study First Received: August 1, 2012
Last Updated: July 2, 2014
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on July 23, 2014