A Study Treating Participants With Early Axial Spondyloarthritis (axSpA) Taking an Intense Treatment Approach Versus Routine Treatment

Sponsor
AbbVie
Study ID
NCT02897115
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — BIOLOGICAL
    Administered every other week by subcutaneous injection for up to 48 weeks, depending on participants' disease activity.
  • Non-steroidal Anti-inflammatory Drugs (NSAIDs) — OTHER
    ASAS recommended NSAID doses to treat axial spondyloarthritis.

Study Details

A study comparing a treat-to-target (T2T) intense treatment approach with routine treatment (Standard of Care \[SOC\]) in reducing disease activity in participants with axial spondyloarthritis (axSpA).

Key Dates

Start date
Sep 12, 2016
Status verified
Nov 2018
Primary completion
Dec 21, 2017
Completion
Dec 21, 2017

Study Design

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

Arms

  • Experimental: Treat-to-Target (T2T)
    Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2 or treatment with the chosen NSAID was not tolerated, , participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.
  • Active Comparator: Standard of Care (SOC)
    Participants received treatment as prescribed by their physician according to the local standard of care.

Primary Outcome Measure

Percentage of Participants With an Ankylosing Spondylitis Disease Activity Score (ASDAS) of Inactive Disease at Week 32 [ Time Frame: Week 32 ]

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