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

NCT01668004 | Completed Phase 4 Results

• 2 other identifiers: 8259-0122012-002458-21
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 start initial anti-TNF therapy and after treatment with golimumab (GLM).

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (2)

• Occurence Rate of Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment

  Uveitis is an extra-articular manifestation of ankylosing spondylitis (AS) involving inflammation of the eye. The occurrence rate (assessed as present/absent) of uveitis attacks was determined over two 1-year long periods regardless of whether the event started during the assessed year: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose.

  Twelve Months Prior to Enrollment to Study Month 12

• Annual Incidence Rate of New Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment

  Uveitis is an extra-articular manifestation of AS involving inflammation of the eye. The annual incidence rate of new uveitis attacks was determined over two 1-year long periods: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose. All participants were counted as contributing a full year of GLM exposure even if discontinuing early. Due to ongoing uveitis cases at time of period entry, participants did not have the same risk of new events during the one year periods. Participants with ongoing uveitis at start of GLM who had the adverse event for the entire treatment period were counted as having the 'new attack' before and no "new attack" after GLM treatment start.

  Twelve Months Prior to Enrollment to Study Month 12

Secondary Outcomes (3)

• Annual Incidence Rate of New-Onset or Flares of Inflammatory Bowel Disease (IBD) and Psoriasis in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment

  Twelve Months Prior to Enrollment to Study Month 12

• Percentage of Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) Responders Following Treatment With GLM

  Baseline (BL), Study Month 3

• Percentage of Ankylosing Spondylitis Disease Activity Score (ASDAS) Responders Following Treatment With GLM

  BL, Study Month 3

Study Arms (1)

GLM 50 mg

EXPERIMENTAL

GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months

Biological: Golimumab

Interventions

Golimumab BIOLOGICAL

GLM 50 mg subcutaneously once monthly.

Also known as: Simponi®

GLM 50 mg

Eligibility Criteria

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

You may qualify if:

• May not have been treated with GLM 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

You may not qualify if:

• Use of any investigational biological or chemical agents within 30 days or 2 half-lives (whichever is longest) of screening

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• van Bentum RE, Heslinga SC, Nurmohamed MT, Gerards AH, Griep EN, Koehorst CBJM, Kok MR, Schilder AM, Verhoef M, van der Horst-Bruinsma IE. Reduced Occurrence Rate of Acute Anterior Uveitis in Ankylosing Spondylitis Treated with Golimumab - The GO-EASY Study. J Rheumatol. 2019 Feb;46(2):153-159. doi: 10.3899/jrheum.180312. Epub 2018 Nov 1.

  PMID: 30385705 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

golimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

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

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 17, 2012
• Study Start: September 3, 2012
• Primary Completion: April 30, 2015
• Study Completion: April 30, 2015
• Last Updated: February 4, 2019
• Results First Posted: August 3, 2016

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share