Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis

Sponsor
AbbVie
Study ID
NCT01808118
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    40 mg every other week
  • Placebo — BIOLOGICAL
    every other week

Study Details

The objective of this multicenter, randomized, double-blind study was to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week SC in maintaining remission in subjects with moderate to severe non-radiographic axial spondyloarthritis.

Key Dates

Start date
Apr 16, 2013
Status verified
Apr 2018
Primary completion
Feb 21, 2017
Completion
Apr 14, 2017

Study Design

Enrollment
673 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Double-Blind Adalimumab
    40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.
  • Experimental: Open-label (OL) Adalimumab
    40 mg every other week (eow), Weeks 0-28. If participants flared during the double-blind period, they had an opportunity to receive at least 12 weeks of open-label adalimumab 40 mg eow.
  • Placebo Comparator: Placebo
    Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.

Primary Outcome Measure

Number of Participants Who Did Not Experience a Flare During Period 2 by Week 68 [ Time Frame: From Week 28 through 68 ]

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