A Phase-IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of Golimumab (MK-8259 [SCH 900259]) After Treatment Withdrawal, Compared With Continued Treatment (Either Full- or Reduced-Treatment Regimen), In Subjects With Non-Radiographic Axial Spondyloarthritis

Merck Sharp & Dohme LLC71 sites in 7 countries323 target enrollmentNovember 7, 2017

ConditionsSpondyloarthritis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Spondyloarthritis
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 323
Locations: 71
Primary Endpoint: Percentage of Participants Without a Disease Activity Flare During Period 2
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of blinded therapy.

Registry

clinicaltrials.gov

Start Date

November 7, 2017

End Date

March 17, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is not of reproductive potential, or is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner while receiving trial medication or within 6 months after the last dose of trial medication
•Has chronic back pain of ≥3 months duration by history
•Has physician-diagnosed active non-radiographic axial spondyloarthritis (nr-axSpA) with disease duration \<= 5 years
•Meets one of the following criteria:
•Has active inflammation on magnetic resonance imaging (MRI) highly suggestive of sacroiliitis associated with spondyloarthropathy and 1 or more of the following spondyloarthritis (SpA) characteristics:
•Inflammatory back pain
•Arthritis (physician-diagnosed)
•Enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness at examination of the site of the insertion of the Achilles tendon or plantar fascia)
•Dactylitis (physician-diagnosed)
•Psoriasis (physician-diagnosed)

Exclusion Criteria

•Has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 on conventional x-rays
•Is a nursing or pregnant female, or intends to become pregnant within 6 months after receiving trial medication
•Intends to donate eggs (female participants) or sperm (male participants) while receiving trial medication or within 6 months after trial medication
•Has any clinically significant condition or situation that would interfere with the trial evaluations or participation in the trial
•Has ever received any cytotoxic drugs, including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents
•Has received any treatment listed below more recently than the indicated off-drug period prior to Screening
•• Disease-modifying anti-rheumatic drugs (30 days off drug)
•• Live vaccinations (3 months off drug)
•• Investigational medications (30 days or 5 half-lives off drug, whichever is longer)
•• Bacille Calmette-Guerin (BCG) vaccination (12 months off drug)

Outcomes

Primary Outcomes

Percentage of Participants Without a Disease Activity Flare During Period 2

Time Frame: Up to 12 months

Disease flare is defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) at two consecutive visits that both show either absolute score ≥2.1 or a post-withdrawal increase of ≥1.1 relative to baseline prior to the first dose of double-blind treatment in Period 2. The ASDAS is a composite index assessing disease activity in axial spondyloarthropathies that consists of 4 self-assessed parameters and 1 laboratory parameter. The self-assessed parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are individually scored on a numeric scale of 0 to 10, with 0 being low activity/impact and 10 being high activity/impact. The self-assessed criteria and the laboratory value of CRP are combined to provide the total ASDAS score, which has a lower limit of 0.6 and no defined upper limit. A higher score indicates greater disease activity.

Secondary Outcomes

Time to First Disease Flare(Month 3, Month 6, Month 9, and Month 12)
Percentage of Participants Achieving ASAS20 Response (Open-label Retreatment)(Up to 12 months)
Percentage of Participants Achieving ASAS Partial Remission (Double-blind Treatment)(Up to 12 months)
Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis International Society) Response (Double-blind Treatment)(Up to 12 months)
Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment(Up to 3 months following start of retreatment)
Percentage of Participants Achieving ASAS40 Response (Open-label Retreatment)(Up to 12 months)
Percentage of Participants Achieving ASAS Partial Remission (Open-label Retreatment)(Up to 12 months)
Percentage of Participants Achieving ASAS40 Response (Double-blind Treatment)(Up to 12 months)
Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment)(Up to 12 months)
Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2(Up to approximately 15 months)
Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment)(Up to 12 months)
Percentage of Participants Achieving Inactive Disease Status (Open-label Retreatment)(Up to 12 months)
Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2(Up to approximately 12 months)
Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment)(Up to 12 months)